Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-27 @ 2:59 AM
Study NCT ID:
NCT03773757
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2018-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Indiana Palliative Excellence in Alzheimer's Care Efforts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sachsg@iu.edu', 'phone': '317-278-5570', 'title': 'Dr. Greg Sachs', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study subjects drawn primarily from two health systems in central Indiana and required to have an English-speaking caregiver. No technical difficulties; targeted enrollment completed on time and intervention and data collection very complete despite coronavirus disease 2019 (COVID-19) pandemic and move to fully remote operations. Low levels of symptoms in patients and caregivers in both arms may have limited ability to demonstrate impact of intervention on these measures.'}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, up to 24 months or the death of the patient', 'description': "Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.", 'eventGroups': [{'id': 'EG000', 'title': 'IN-PEACE Dementia Care Coordination', 'description': 'IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.\n\nIN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 77, 'seriousNumAtRisk': 99, 'deathsNumAffected': 40, 'seriousNumAffected': 50}, {'id': 'EG001', 'title': 'Usual Care', 'description': "The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.", 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 89, 'seriousNumAtRisk': 102, 'deathsNumAffected': 43, 'seriousNumAffected': 61}], 'otherEvents': [{'term': 'Falls', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 70, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 78, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elopements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Accidents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ED Visits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 125, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 212, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 82, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 102, 'numEvents': 113, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IN-PEACE Dementia Care Coordination', 'description': 'IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.\n\nIN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study."}], 'classes': [{'categories': [{'measurements': [{'value': '9.149', 'spread': '0.747', 'groupId': 'OG000'}, {'value': '9.39', 'spread': '0.756', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8719', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Longitudinal measures of NPI-Q patient over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.'}], 'paramType': 'MEAN', 'timeFrame': '0-24 months', 'description': "The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. Each symptom reported as present is scored on a scale of 1-3 with higher scores indicating more severity of the symptom: mild, moderate, or severe. The NPI-Q Patient Symptom and Severity total score is constructed by summing the value of each presenting symptom's severity and ranges from 0-36 with higher scores indicating more severe patient neuropsychiatric symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.'}, {'type': 'SECONDARY', 'title': 'Symptom Management - End of Life for Dementia (SM-EOLD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IN-PEACE Dementia Care Coordination', 'description': 'IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.\n\nIN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study."}], 'classes': [{'categories': [{'measurements': [{'value': '28.36', 'spread': '0.972', 'groupId': 'OG000'}, {'value': '26.133', 'spread': '0.984', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8389', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Longitudinal measures of SM-EOLD over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.'}], 'paramType': 'MEAN', 'timeFrame': '0-24 months', 'description': 'The Symptom Measures in End-of-Life Dementia (SM-EOLD) measures the presence and frequency of 9 symptoms experienced by the person with dementia (PWD) in the previous 90 days per caregiver report: pain, shortness of breath, depression, fear, anxiety, agitation, calm, skin breakdown, and resistance to care. Each symptom is scored on a scale ranging 0 - 5 (daily, several days a week, once a week, 2 or 3 days a month, once a month, never) with higher scores indicating better symptom control. The SM-EOLD total score is constructed by summing the value of each item, and ranges from 0-45 with higher scores indicating better symptom control (comfort).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire (PHQ-8) Caregiver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IN-PEACE Dementia Care Coordination', 'description': 'IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.\n\nIN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study."}], 'classes': [{'categories': [{'measurements': [{'value': '4.472', 'spread': '0.507', 'groupId': 'OG000'}, {'value': '4.522', 'spread': '0.511', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3431', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Longitudinal measures of PHQ-8 over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.'}], 'paramType': 'MEAN', 'timeFrame': '0-24 months', 'description': 'The Patient Health Questionnaire-8 item measures the frequency of depressive symptoms experienced by the caregiver in the last two weeks per caregiver report. Each symptom is scored on a scale of 0-3 (not at all, several days, more than half the days, nearly every day) with higher scores indicating more frequency of depressive symptoms. The PHQ-8 Caregiver total score is constructed by summing the value of each item and ranges from 0-24 with higher scores indicating more frequent depressive symptoms in the caregiver.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.'}, {'type': 'SECONDARY', 'title': 'Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IN-PEACE Dementia Care Coordination', 'description': 'IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.\n\nIN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study."}], 'classes': [{'categories': [{'measurements': [{'value': '9.282', 'spread': '1.063', 'groupId': 'OG000'}, {'value': '10.148', 'spread': '1.073', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6612', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Longitudinal measures of NPI-Q caregiver distress over 24 months were compared between the two groups using mixed effects model including a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.'}], 'paramType': 'MEAN', 'timeFrame': '0-24 months', 'description': "The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. If the symptom was reported as present, then the caregiver rated the level of distress they experienced related to the patient's symptom on a scale of 0-5 with higher scores indicating more distress. The NPI-Q Caregiver Distress total score is constructed by summing the value of each distress item and ranges from 0-60 with higher scores indicating more caregiver distress.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.'}, {'type': 'SECONDARY', 'title': 'Emergency Department Visits and Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IN-PEACE Dementia Care Coordination', 'description': 'IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.\n\nIN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study."}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Zero-Inflated Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A zero-inflated Poisson (ZIP) model was used to compare the mean numbers of hospitalization/ED events between the two groups. The ZIP model consists of a combination of a standard Poisson distribution for count data and a binary logistic regression model to account for additional zero events exceeding what would be expected from an underlying Poisson distribution.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-24 months', 'description': 'Combined measure of counts of emergency department (ED) visits and hospital admissions drawn from hospital reported data in the Indiana Network for Patient Care (INPC) database, managed by the Indiana Health Information Exchange (IHIE). As pre-specified, this data only includes the patient from each dyad and not the caregiver.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified, this data only includes the patient from each dyad and not the caregiver.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IN-PEACE Dementia Care Coordination', 'description': 'IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.\n\nIN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': "The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '204'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': "Recruitment started on 3/14/2019 and ended on 12/21/2020. Recruitment locations included two health systems and personal referrals at a caregiver symposium within a 50-mile radius of Indianapolis. Initially, recruitment included an in-person approach in the medical clinic followed by in-person enrollment in the caregiver's home. After the Institutional Review Board (IRB) approved verbal consent 3/17/2020, all recruitment took place over the phone.", 'preAssignmentDetails': 'Data values reported in the Participant Flow represent individual participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IN-PEACE Dementia Care Coordination', 'description': 'IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.\n\nIN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': "The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Patient Participants', 'categories': [{'measurements': [{'value': '83.7', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '83.4', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '83.6', 'spread': '7.9', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver Participants', 'categories': [{'measurements': [{'value': '60.8', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Patient Participants', 'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver Participants', 'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Patient Participants', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver Participants', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'During baseline, the question was asked: What ethnic group would you consider yourself to be a member? Responses available were: Hispanic or Latino, Not Hispanic or Latino, or Refused to answer.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'African American: PWD', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'African American: Caregiver', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'White: PWD', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'White: Caregiver', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Others: PWD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Others: Caregiver', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Refused to Answer: PWD', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Refused to Answer: Caregiver', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregivers chose 1 or more options for race for themselves and the person with dementia (PWD): American Indian or Alaskan Native, Asian, Pacific Islander, African American (not Hispanic), Filipino, White or Refused to answer. To ensure statistical power for analyses, those who chose African American as at least one race they identified with are counted as African American. Other combinations not included in African American or White are counted as Others.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'All dyads (patient and caregiver) were enrolled within 50-mile radius of metropolitan Indianapolis, Indiana area.', 'unitOfMeasure': 'Dyad: Patient and Caregiver', 'denomUnitsSelected': 'Dyad: Patient and Caregiver'}, {'title': 'Education', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'PWD', 'categories': [{'title': 'High School or Less', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Some college or college degree', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Post graduate', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'did not answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver', 'categories': [{'title': 'High School or Less', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Some college or college degree', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Post graduate', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'did not answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregivers were asked to identify their own education level and the education level of the person with dementia (PWD): high school or less, some college or college degree, post graduate.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Marital Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'PWD', 'categories': [{'title': 'Divorced/Separated', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Married/Living together', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Never Married', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Widowed', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver', 'categories': [{'title': 'Divorced/Separated', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Married/Living together', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Never Married', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Widowed', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregivers chose marital status for themselves and for person with dementia (PWD): Single never married, Married, Widowed, Divorced, Separated, or Living together.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Income', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'PWD : Under $24,999', 'categories': [{'title': 'Yes', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'PWD : $25,000 - 49,999', 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}, {'title': 'PWD : $50,000 - 99,999', 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': 'PWD : $100,000 and over', 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}, {'title': 'PWD : Do not wish to answer', 'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}, {'title': 'PWD : Caregiver is the spouse', 'categories': [{'title': 'Yes', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver : Under $24,999', 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver : $25,000 - 49,999', 'categories': [{'title': 'Yes', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver : $50,000 - 99,999', 'categories': [{'title': 'Yes', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver : $100,000 and over', 'categories': [{'title': 'Yes', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'Caregiver : Do not wish to answer', 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregivers chose income range for themselves as well as the person with dementia (PWD): under $24,999, $25,000-49,999, $50,000-99,999, $100,000 and over, do not wish to answer.\n\nIf the caregiver relationship to the PWD was spouse, then the income range chosen for the caregiver counted as that of the PWD.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Caregiver Relationship to Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'title': 'Spouse/Partner', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Daughter/Son/Daughter-in-Law/Son-in-Law', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Grandchild', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Other relationship', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregivers identified their relationship to the person with dementia (PWD): spouse/partner, daughter/son/daughter-in-law/son-in-law, grandchild, or other relationship.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Patient Institution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'title': 'Eskenazi', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'IU Health', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'St. Vincent', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patient institution data was pulled from INPC to database or supplied by caregivers who self-referred at events: Eskenazi, IU Health, or St. Vincent.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Functional Assessment Staging Tool for Dementia (FAST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Moderate (FAST=5)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Severe (FAST=6-7)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Caregivers responded "yes" or "no" to 12 questions regarding the functional ability of the person with dementia (PWD). Each question aligned with the stages in the FAST tool. Scoring calculated if PWD was stage 5 (moderate) through stages 6 (severe) and 7 (very severe).', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Patient Medical Conditions (Comorbidities)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Asthma, emphysema, or chronic bronchitis', 'categories': [{'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}, {'title': 'High blood pressure or hypertension', 'categories': [{'title': 'Yes', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'High blood sugar or diabetes', 'categories': [{'title': 'Yes', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}, {'title': 'Arthritis or rheumatism (inflammation of the joints)', 'categories': [{'title': 'Yes', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Angina, heart failure, or other types of heart disease', 'categories': [{'title': 'Yes', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}, {'title': "Stroke, seizures, Parkinson's disease, or another neurological condition", 'categories': [{'title': 'Yes', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Liver disease', 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}, {'title': 'Kidney or renal disease', 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}, {'title': 'Cancer', 'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Caregivers responded "yes" or "no" if a doctor or another health care worker had diagnosed or treated the person with dementia (PWD) with the following medical problems in the past 3 years. Nine groups of medical issues were listed and a "yes" was counted if at least one item from a group was a "yes." Caregivers were instructed not to count the PWD Alzheimer\'s or dementia diagnosis as "another neurological condition" in the 6th item.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Montreal Cognitive Assessment (MoCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '11.4', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '10.9', 'spread': '4.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The MoCA was administered to support FAST stage screening results and caregiver self-report of the person with dementia's (PWD) cognitive decline. Scores for the MoCA range from 0-30 with 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The MoCA was administered with person with dementia (PWD) if caregiver gave permission. In some cases, the PWD was unable to take the test. When the IRB approved protocol amendment 12 to recruit fully remote and with verbal consent only, the MoCA was no longer administered during baseline.The total MoCAs administered for the study was 32.'}, {'title': 'Neuropsychiatric Inventory Questionnaire (NPI-Q: PWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '9.4', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '9.7', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. Each symptom reported as present is scored on a scale of 1-3 with higher scores indicating more severity of the symptom: mild, moderate, or severe. The NPI-Q Patient Symptom and Severity total score is constructed by summing the value of each presenting symptom's severity and ranges from 0-36 with higher scores indicating more severe patient neuropsychiatric symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Symptom Measures in End-of-Life Dementia (SM-EOLD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '9', 'groupId': 'BG000'}, {'value': '28.8', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '8.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Symptom Measures in End-of-Life Dementia (SM-EOLD) measures the presence and frequency of 9 symptoms experienced by the person with dementia (PWD) in the previous 90 days per caregiver report: pain, shortness of breath, depression, fear, anxiety, agitation, calm, skin breakdown, and resistance to care. Each symptom is scored on a scale ranging from 0 to 5: never, once a month, 2 or 3 days a month, once a week, several days a week, daily. The SM-EOLD score is constructed by summing the value of each item, and ranges from 0-45 with higher scores indicating less symptom control (comfort).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Physical Self-Maintenance Scale/Activities of Daily Living (PSMS/ADLs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '1.1', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Physical Self-Maintenance Scale/Activities of Daily Living (PSMS/ADLs) measures the level of functioning of the person with dementia (PWD) in 6 basic and 7 instrumental ADLs in the previous 90 days per caregiver report. Only the 6 basic ADLs were included in analyses: toileting, bathing, dressing, grooming, physical ambulation, and feeding. Each ADL is scored as either 1 (independent in that activity) or 0 (needs assistance). The total score is constructed by summing the value of each of these 6 items and ranges from 0-6 with higher scores indicating less impairment and more independence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Neuropsychiatric Inventory Questionnaire (NPI-Q: Caregiver Distress)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '10.4', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '10.6', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. If the symptom was reported as present, then the caregiver rated the level of distress they experienced related to the patient's symptom on a scale of 0-5 with higher scores indicating more distress. The NPI-Q Caregiver Distress total score is constructed by summing the value of each distress item and ranges from 0-60 with higher scores indicating more caregiver distress.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Patient Health Questionnaire (PHQ-8: Caregiver)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '4.1', 'spread': '4', 'groupId': 'BG001'}, {'value': '3.9', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Patient Health Questionnaire-8 item measures the frequency of depressive symptoms experienced by the caregiver in the last two weeks per caregiver report. Each symptom is scored on a scale of 0-3 (not at all, several days, more than half the days, nearly every day) with higher scores indicating more frequency of depressive symptoms. The PHQ-8 Caregiver total score is constructed by summing the value of each item and ranges from 0-24 with higher scores indicating more frequent depressive symptoms in the caregiver.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Caregiver Strain Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'units': 'Dyad: Patient and Caregiver', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '6.8', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Caregiver Strain Index is a screening instrument which can be used to identify strain of carers, assess their ability to go on caring and to identify areas where support may be needed. Caregivers responded "yes" or "no" to 13 questions. The total score is determined by a count of the "Yes" answers. Scores may range from 0-13; a score of 7 or greater indicates a high level of stress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Dyad: Patient and Caregiver', 'populationDescription': 'These variables were collected for all participant dyads (patient plus caregiver) randomized to either the usual care arm or dementia care coordination arm. Some variables may not total overall participants if caregiver opted not to answer that item.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-10', 'size': 301636, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-26T11:34', 'hasProtocol': True}, {'date': '2018-03-29', 'size': 198049, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-21T12:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2018-11-21', 'resultsFirstSubmitDate': '2024-01-01', 'studyFirstSubmitQcDate': '2018-12-11', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-06', 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity', 'timeFrame': '0-24 months', 'description': "The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. Each symptom reported as present is scored on a scale of 1-3 with higher scores indicating more severity of the symptom: mild, moderate, or severe. The NPI-Q Patient Symptom and Severity total score is constructed by summing the value of each presenting symptom's severity and ranges from 0-36 with higher scores indicating more severe patient neuropsychiatric symptoms."}], 'secondaryOutcomes': [{'measure': 'Symptom Management - End of Life for Dementia (SM-EOLD)', 'timeFrame': '0-24 months', 'description': 'The Symptom Measures in End-of-Life Dementia (SM-EOLD) measures the presence and frequency of 9 symptoms experienced by the person with dementia (PWD) in the previous 90 days per caregiver report: pain, shortness of breath, depression, fear, anxiety, agitation, calm, skin breakdown, and resistance to care. Each symptom is scored on a scale ranging 0 - 5 (daily, several days a week, once a week, 2 or 3 days a month, once a month, never) with higher scores indicating better symptom control. The SM-EOLD total score is constructed by summing the value of each item, and ranges from 0-45 with higher scores indicating better symptom control (comfort).'}, {'measure': 'Patient Health Questionnaire (PHQ-8) Caregiver', 'timeFrame': '0-24 months', 'description': 'The Patient Health Questionnaire-8 item measures the frequency of depressive symptoms experienced by the caregiver in the last two weeks per caregiver report. Each symptom is scored on a scale of 0-3 (not at all, several days, more than half the days, nearly every day) with higher scores indicating more frequency of depressive symptoms. The PHQ-8 Caregiver total score is constructed by summing the value of each item and ranges from 0-24 with higher scores indicating more frequent depressive symptoms in the caregiver.'}, {'measure': 'Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress', 'timeFrame': '0-24 months', 'description': "The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. If the symptom was reported as present, then the caregiver rated the level of distress they experienced related to the patient's symptom on a scale of 0-5 with higher scores indicating more distress. The NPI-Q Caregiver Distress total score is constructed by summing the value of each distress item and ranges from 0-60 with higher scores indicating more caregiver distress."}, {'measure': 'Emergency Department Visits and Hospitalizations', 'timeFrame': '0-24 months', 'description': 'Combined measure of counts of emergency department (ED) visits and hospital admissions drawn from hospital reported data in the Indiana Network for Patient Care (INPC) database, managed by the Indiana Health Information Exchange (IHIE). As pre-specified, this data only includes the patient from each dyad and not the caregiver.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '11001602', 'type': 'RESULT', 'citation': 'Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.'}, {'pmid': '11723370', 'type': 'RESULT', 'citation': 'Volicer L, Hurley AC, Blasi ZV. Scales for evaluation of End-of-Life Care in Dementia. Alzheimer Dis Assoc Disord. 2001 Oct-Dec;15(4):194-200. doi: 10.1097/00002093-200110000-00005.'}, {'pmid': '15550799', 'type': 'RESULT', 'citation': 'Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.'}, {'pmid': '39878993', 'type': 'DERIVED', 'citation': 'Sachs GA, Johnson NM, Gao S, Torke AM, Hickman SE, Pemberton A, Vrobel A, Pan M, West J, Kroenke K. Palliative Care Program for Community-Dwelling Individuals With Dementia and Caregivers: The IN-PEACE Randomized Clinical Trial. JAMA. 2025 Mar 18;333(11):962-971. doi: 10.1001/jama.2024.25845.'}, {'pmid': '37149000', 'type': 'DERIVED', 'citation': "Holtz LR, Kroenke K, Gao S, Hickman SE, Torke AM, Johnson NM, Pemberton A, Vrobel A, Pan M, Sachs GA. Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE): Protocol for a randomized controlled trial in persons with advanced dementia. Contemp Clin Trials. 2023 Jul;130:107217. doi: 10.1016/j.cct.2023.107217. Epub 2023 May 4."}]}, 'descriptionModule': {'briefSummary': "The overarching goal of this research is to improve the care of community dwelling patients with dementia and their family caregivers through an innovative model of supportive care that combines an existing, evidence-based intervention for dementia care with an innovative intervention for palliative care in dementia. The intervention projects this care into the homes of patients and caregivers, empowering caregivers, and integrating with ongoing care. IN-PEACE will enroll 200 patient-caregiver dyads, randomizing 100 dyads each to the intervention and usual care arms and follow for 24 months with quarterly outcome assessments. The core of the multi-component intervention is regular, proactive telephone contact by a dementia care coordinator (DCC; social worker or RN) to anticipate and identify patients' symptoms and caregivers needs and address by utilizing specific, evidence-based protocols. Protocols cover basic dementia care, caregiver distress, neuropsychiatric symptoms, pain, navigating the hospital, feeding difficulties, and transition to hospice. The intervention also involves advance care planning and support with caregivers tailored to decisions faced in dementia care, highlighting where palliative care options can replace the default that often results in burdensome treatments.\n\nThe primary aim of IN-PEACE is to test the effect of the intervention on patients' neuropsychiatric symptoms. Other aims include testing the effect of IN-PEACE on patients' overall symptom outcomes, caregiver mood and distress, and the provision of burdensome treatments to patients (hospitalizations and emergency room visits).", 'detailedDescription': 'Dementia is an increasingly prevalent, costly and burdensome condition. The dramatic aging of the US population is creating a dementia "epidemic" that our health care system is poorly prepared to handle. More than 5 million people are affected by Alzheimer\'s disease (AD) and related dementias in 2016, with that number estimated to nearly triple to 13.8 million by 2050. The direct health care costs alone for dementia care are projected to increase from $236 billion in 2016 to more than $1 trillion in 2050. In addition to cognitive and functional deterioration, patients with dementia experience behavioral and psychological complications such as agitation and depression. Family caregivers of patients with dementia experience higher levels of anxiety, depression, chronic fatigue, and an increased mortality risk.\n\nDementia and palliative care are national research priorities. Both dementia and palliative care have been identified as priority conditions for research and quality improvement by numerous organizations such as the Institute of Medicine, National Quality Forum, the Centers for Medicare and Medicaid Services, and Agency for Healthcare Research and Quality and National Institute on Aging. In addition, a workgroup developing milestones for care and support under the U.S. National Alzheimer\'s Plan has explicitly stated that palliative care needs to be incorporated throughout the course of caring for patients and families affected by dementia.\n\n2.0 Rationale and Specific Aims\n\nAim 1: To test the effect of the IN-PEACE intervention on patients\' neuropsychiatric symptoms (e.g., agitation/aggression, anxiety, repetitive behaviors). Mixed effects models will be used to compare repeated Neuropsychiatric Inventory Questionnaire (NPI-Q) scores obtained at 3, 6, 9, 12, 15, 18, 21, and 24 months. Repeatedly measured NPI-Q scores will be the dependent variable in the model.\n\nAim 2: To test the effect of the IN-PEACE intervention on patients\' overall symptom outcomes. Analyses in this aim will use repeatedly measured Symptom Measures in End-of-Life Dementia (SM-EOLD) scores over 24 months of follow-up as the dependent variable in the mixed effects model, similarly to the approach described for Aim 1.\n\nAim 3: To test the effect of the IN-PEACE intervention on caregivers\' distress and mood. Aim 3 analyses will use repeatedly measured caregiver NPI-Q distress scores and caregiver Patient Health Questionnaire (PHQ-9) over 24 months of follow-up as the dependent variables in separate mixed effects models, similar to the approach for Aim 1.\n\nAim 4: Evaluate the effect of the IN-PEACE intervention on ER/hospital use. ER/hospitalization events will be obtained from accessing electronic medical records maintained by the Indiana Health Information Exchange (IHIE) and the Indiana Network for Patient Care (INPC). Poisson regression models will be used to compare rates of any ER/hospitalization event between the two groups while adjusting for dementia severity and significant baseline variables that differ between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Community-dwelling and living in the Indianapolis metropolitan area; Patient with an established diagnosis of dementia of any etiology; Dementia in the moderate (FAST stage 5) to severe stage (FAST 6-7); and English-speaking Primary caregiver informant enrolled in study.\n\nExclusion Criteria: Patient with dementia residing in a nursing facility or receiving hospice care; Patient or Caregiver with long-standing history of severe mental illness or Psychiatric disorder preexisting the dementia diagnosis. Initially, non-English speaking patients were excluded. On April 14, 2020, Institutional Review Board (IRB) Amendment eliminated this exclusion so non-English speaking patients could be enrolled as long as their Caregiver was English-speaking and able to complete assessments.'}, 'identificationModule': {'nctId': 'NCT03773757', 'acronym': 'IN-PEACE', 'briefTitle': "Indiana Palliative Excellence in Alzheimer's Care Efforts", 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': "Indiana Palliative Excellence in Alzheimer's Care Efforts- Randomized Control Trial", 'orgStudyIdInfo': {'id': '1707549593'}, 'secondaryIdInfos': [{'id': '1R01AG057733-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG057733-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IN-PEACE Dementia Care Coordination', 'description': 'In-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.', 'interventionNames': ['Behavioral: IN-PEACE Dementia Care Coordination']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': "The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study."}], 'interventions': [{'name': 'IN-PEACE Dementia Care Coordination', 'type': 'BEHAVIORAL', 'description': 'Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.', 'armGroupLabels': ['IN-PEACE Dementia Care Coordination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Sandra Eskenazi Center for Brain Care Innovation', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Greg A Sachs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regenstrief Institute, Inc.', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Division Chief General Internal Medicine and Geriatrics', 'investigatorFullName': 'Greg Sachs', 'investigatorAffiliation': 'Indiana University'}}}}