Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
Study NCT ID:
NCT04418232
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2020-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility of a Systems Approach for Alzheimer's Services Among Latinos Attending Primary Care Practices
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': 'jperales@kumc.edu', 'phone': '913-588-3716', 'title': 'Jaime Perales Puchalt', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Adverse Events were not monitored in any participant population due to this project being minimal risk. instead, the research team monitored unanticipated problems.', 'eventGroups': [{'id': 'EG000', 'title': 'Alianza Latina', 'description': "The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators. This number includes 100 caregivers of 84 care recipients who underwent the Alianza Latina care support intervention; 26 caregivers were part of 10 clusters of 2 (n=5), 3 (n=4), and 4 (n=1) caregivers of the same person with dementia. This number also includes results from 59 primary care providers who underwent a dementia training delivered as standard training by the KU Alzheimer's Disease Research Center. Data for all 3 groups are provided together because they are part of the same intervention, and not interventions that were compared. Mortality only happened among care recipients.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 243, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Provider Recruitment Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.44', 'spread': '2.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the 9 months of the provider intervention period', 'description': 'Metrics of the number of providers who agree to be trained per month', 'unitOfMeasure': 'Providers trained per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Provider Retention Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 9 months of the provider intervention period', 'description': 'Metrics of the percentage of providers who continue to partner with the study team by the end of the provider intervention period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary care providers that are part of Aim 2a'}, {'type': 'PRIMARY', 'title': 'Provider Fidelity Feasibility 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'title': 'not at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'to some degree', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'usually', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'almost always', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'always', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months (end of the provider intervention period)', 'description': 'Percentage of providers able to implement screenings in regular workflow, measured via survey with the question "To what extent were you able to implement screenings in regular workflow" with three response options: "not at all", "to some degree", "usually", "almost always" and "always"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary care providers that are part of Aim 2a'}, {'type': 'PRIMARY', 'title': 'Provider Assessment Feasibility 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 9 months of the provider intervention period', 'description': 'Metrics of the percentage of providers who complete baseline and follow-up surveys about dementia knowledge, attitudes and skills', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary care providers that are part of Aim 2a'}, {'type': 'PRIMARY', 'title': 'Provider Fidelity Feasibility 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.77', 'spread': '3.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the 9 months of the provider intervention period', 'description': 'Metrics of the Number of referrals to Health Navigator per month', 'unitOfMeasure': 'Referrals per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary care providers that are part of Aim 2a'}, {'type': 'PRIMARY', 'title': 'Overall Provider Satisfaction With Training', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Slightly', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Moderately', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'very much', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Extremely', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months (end of the provider intervention period)', 'description': 'Survey question including a 5-item Likert scale on satisfaction with training (not at all to very much)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary care providers that are part of Aim 2a'}, {'type': 'PRIMARY', 'title': 'Importance of Navigators to Providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Slightly', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Moderately', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very much', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Extremely', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months (end of the provider intervention period)', 'description': 'Survey question including a 5-item Likert scale on the perceived importance of Navigators to providers (not at all to very much)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary care providers that are part of Aim 2a (Only among the people who reported using health navigators)'}, {'type': 'PRIMARY', 'title': 'Participant Recruitment Fidelity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 15 months of the whole intervention period', 'description': 'Metrics of percentage of referred Latino dementia dyads who enroll in Health Navigator services', 'unitOfMeasure': 'Percentage of dyads', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow because this variable reports the dyads who end up enrolling (100) out of the ones referred (127)'}, {'type': 'PRIMARY', 'title': 'Participant Retention Fidelity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 6 months of the Navigator intervention period', 'description': 'Metrics of percentage of referred Latino dementia dyads followed up at six months', 'unitOfMeasure': 'Percentage of dyads', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow because this variable reports the dyads who are followed up (88) out of the ones referred (127)'}, {'type': 'PRIMARY', 'title': 'Participant Assessment Fidelity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 6 months of the Navigator intervention period', 'description': 'Metrics of the percentage of planned baseline and follow-up survey ratings completed', 'unitOfMeasure': 'Percent of dyads', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are dyads (caregivers and, when possible, care recipients)'}, {'type': 'PRIMARY', 'title': 'Participant Treatment Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 6 months of the Navigator intervention period', 'description': 'Metrics of the percentage of referred Latino dementia dyads who attend at least 50% of Health Navigator visits', 'unitOfMeasure': 'Percentage of dyads', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are dyads (caregivers and, when possible, care recipients)'}, {'type': 'PRIMARY', 'title': 'Overall Participant Satisfaction With the Clinic Side of the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Somehow', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Very', 'measurements': [{'value': '52', 'groupId': 'OG000'}]}, {'title': 'Extremely', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Does not know', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after baseline', 'description': "Survey question including a 5-item Likert scale on caregivers' satisfaction with clinic services (not at all to very much)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are caregivers'}, {'type': 'PRIMARY', 'title': 'Overall Participant Satisfaction With the Navigator Side of the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Somehow', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Very', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'Extremely', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after baseline', 'description': 'Survey question to the caregiver including a 5-item Likert scale on satisfaction with Navigator services (not at all to very much)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are caregivers'}, {'type': 'PRIMARY', 'title': 'Participant Suggestions of Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'title': 'Responded', 'measurements': [{'value': '88', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after baseline', 'description': 'Survey question to the caregiver including an open-ended question about which aspects of the intervention they would change', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are caregivers'}, {'type': 'PRIMARY', 'title': 'Practitioner Adherence to Guideline Recommendations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months after baseline', 'description': '10-item checklist administered to the dyads asking about the implementations of different aspects of dementia service guidelines', 'unitOfMeasure': 'Guideline Items in the checklist covered', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '87 respondents'}, {'type': 'SECONDARY', 'title': "Patients' Behavioral Symptoms", 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '6.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months from baseline', 'description': 'Brief version of the Neuropsychiatry Inventory Questionnaire: This is a validated clinical instrument for evaluating psychopathology in dementia. If any of the 12 neuropsychiatric symptoms is present, caregivers rate their loved one\'s severity on a three-point scale (mild-severe). For example, if the caregiver responds yes to "is the patient resistive to help from others at times, or hard to handle?", the following question would follow: "rate the severity of the symptom". An overall severity summary score is calculated by adding the severity scores of all items, ranging from 0 to 36, and higher scores mean higher severity.', 'unitOfMeasure': 'Change in units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are caregivers on behalf of care recipients'}, {'type': 'SECONDARY', 'title': "Patients' Depression", 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'spread': '3.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months from baseline', 'description': 'Short Geriatric Depression Scale: This scale measures depressive symptomatology, and consists of 15 yes vs no questions. Of the 15 items, 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. A summary score is obtained ranging from 0 to 15, with higher scores meaning more severe depressive symptomatology.', 'unitOfMeasure': 'Change in units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are caregivers on behalf of care recipients or care recipients themselves when possible'}, {'type': 'SECONDARY', 'title': "Patients' Quality of Life", 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '6.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months from baseline', 'description': "Quality of Life in Alzheimer's Disease: The Quality of Life in Alzheimer's Disease is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better quality of life.", 'unitOfMeasure': 'Change in units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are caregivers on behalf of care recipients or care recipients themselves when possible'}, {'type': 'SECONDARY', 'title': "Caregivers' Quality of Life", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.79', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months from baseline', 'description': 'In general, how satisfied are you with your life?" with a 4-point scale from 1 (Very Satisfied) to 4 (Very Dissatisfied)', 'unitOfMeasure': 'Change in units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are caregivers on their behalf'}, {'type': 'SECONDARY', 'title': "Caregivers' Depression", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.43', 'spread': '6.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months from baseline', 'description': '10-item Center for Epidemiologic Studies-Depression scale (CES-D-10): This is a 10-item, self-report rating scale that measures characteristic symptoms of depression in the past week (e.g. depression, loneliness, restless sleep). Each item is rated on a 4-point scale, from 0 (rarely or none of the time) to 3 (most or all of the time) with positively worded items (items 5 and 8) reverse scored. Items yield summary scores that range from 0 to 30, with higher scores indicating higher severity. An example of an item is: "I was bothered by things that usually don\'t bother me"', 'unitOfMeasure': 'Change in units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are caregivers on their behalf'}, {'type': 'SECONDARY', 'title': "Caregivers' Burden", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'spread': '4.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months from baseline', 'description': 'Short Zarit Burden Interview: This caregiver burden scale has 6 items that address the perceived impact of the act of providing care on the physical health, emotional health, social activities and financial situation of the caregiver. Each item has five response options ranging from "never" to "nearly always". A total score is obtained by adding scores in all items, with a range from 0 to 24. Higher scores mean higher burden.', 'unitOfMeasure': 'Change in units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants responding to these are caregivers on their behalf'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina were:\n\n1. Primary care provider education: This training was informed by the Health Belief Model and Social Learning Theory and included clinically-focused lectures, case examples with discussion, videos and materials. Topics included dementia detection and diagnosis, treatment, and care, early detection, patient empowerment, and cultural competence. The modality of all training events was live and online via videoconferences.\n2. Coordinated care: This program provided Latino dementia patients with enhanced chronic care through bilingual Health Navigators. Alianza Latina is a six-month bilingual intervention, designed to cater to the unique needs of Latino caregivers. It integrates CuidaTEXT, an SMS program, with monthly phone consultations facilitated by a trained coach from the research team. These consultations aim to identify unaddressed needs and provide necessary support. Participants in CuidaTEXT receive scheduled messages and can also request on-demand assistance by texting. CuidaTEXT entails sending 1-3 automated daily messages covering various aspects such as logistics, dementia education, self-care, social support, end-of-life care, managing dementia-related behaviors, and problem-solving strategies. Additionally, participants could text keyword-based queries for immediate assistance on the above-mentioned topics and engage in live chat sessions with the coach for further guidance upon request.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': "This number includes 100 caregivers of 84 care recipients who underwent the Alianza Latina care support intervention; 26 caregivers were part of 10 clusters of 2 (n=5), 3 (n=4), and 4 (n=1) caregivers of the same person with dementia.\n\nThis number also includes results from 59 primary care providers who underwent a dementia training delivered as standard training by the KU Alzheimer's Disease Research Center.", 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}]}, {'type': 'COMPLETED', 'comment': "This number includes 88 caregivers of 73 care recipients who completed the Alianza Latina study.\n\nThis number also includes results from 11 primary care providers who completed the 6-month survey after the dementia training delivered as standard training by the KU Alzheimer's Disease Research Center.", 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}]}], 'preAssignmentDetails': 'This study includes 100 dyads. Each dyad is formed by a unique caregiver and a care recipient. Ten care recipients are in more than one dyad, as more than one of their caregivers participated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Care recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Primary care providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Care recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '78.2', 'spread': '10.2', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52.0', 'spread': '10.2', 'groupId': 'BG000'}]}]}, {'title': 'Primary care providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49.5', 'spread': '12.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers)'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Care recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Primary care providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Care recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Primary care providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Care recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}, {'title': 'Primary care providers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed in row differs from overall because we are reporting different samples (care recipients, caregivers and primary care providers).'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Caregivers' relation to care recipients", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Children', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Partner', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Children-in-law', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "Number analyzed in row differs from overall because it only refers to caregivers' relation to care recipients."}, {'title': 'Dementia diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'title': "Alzheimer's dementia", 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Unspecified dementia', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Vascular dementia', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': "Lewy Bodies/Parkinson's dementia", 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Mixed dementia', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Frontotemporal dementia', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Mild Cognitive Impairment', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed in row differs from overall, because analyses only refer to care recipients.'}, {'title': 'Years of education', 'classes': [{'title': 'Care recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '20.4', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed in row differs from overall because we are reporting different samples (care recipients and caregivers).'}], 'populationDescription': 'Analyses include the 59 primary care providers from aim 2a, and the 100 caregivers and 84 care recipients that form the 100 dyads from Aim 2b. Each dyad is formed by a unique caregiver and a care recipient. Ten care recipients are in more than one dyad, as more than one of their caregivers participated in the study. For clarity of results, baseline variables refer to care recipients unless the variable name states that it refers to a different sample (caregiver or primary care provider).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-06', 'size': 321512, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-02T10:40', 'hasProtocol': True}, {'date': '2022-02-02', 'size': 176626, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-02T10:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2020-06-02', 'resultsFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-18', 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provider Recruitment Feasibility', 'timeFrame': 'During the 9 months of the provider intervention period', 'description': 'Metrics of the number of providers who agree to be trained per month'}, {'measure': 'Provider Retention Feasibility', 'timeFrame': 'During the 9 months of the provider intervention period', 'description': 'Metrics of the percentage of providers who continue to partner with the study team by the end of the provider intervention period'}, {'measure': 'Provider Fidelity Feasibility 1', 'timeFrame': '9 months (end of the provider intervention period)', 'description': 'Percentage of providers able to implement screenings in regular workflow, measured via survey with the question "To what extent were you able to implement screenings in regular workflow" with three response options: "not at all", "to some degree", "usually", "almost always" and "always"'}, {'measure': 'Provider Assessment Feasibility 1', 'timeFrame': 'During the 9 months of the provider intervention period', 'description': 'Metrics of the percentage of providers who complete baseline and follow-up surveys about dementia knowledge, attitudes and skills'}, {'measure': 'Provider Fidelity Feasibility 2', 'timeFrame': 'During the 9 months of the provider intervention period', 'description': 'Metrics of the Number of referrals to Health Navigator per month'}, {'measure': 'Overall Provider Satisfaction With Training', 'timeFrame': '9 months (end of the provider intervention period)', 'description': 'Survey question including a 5-item Likert scale on satisfaction with training (not at all to very much)'}, {'measure': 'Importance of Navigators to Providers', 'timeFrame': '9 months (end of the provider intervention period)', 'description': 'Survey question including a 5-item Likert scale on the perceived importance of Navigators to providers (not at all to very much)'}, {'measure': 'Participant Recruitment Fidelity', 'timeFrame': 'During the 15 months of the whole intervention period', 'description': 'Metrics of percentage of referred Latino dementia dyads who enroll in Health Navigator services'}, {'measure': 'Participant Retention Fidelity', 'timeFrame': 'During the 6 months of the Navigator intervention period', 'description': 'Metrics of percentage of referred Latino dementia dyads followed up at six months'}, {'measure': 'Participant Assessment Fidelity', 'timeFrame': 'During the 6 months of the Navigator intervention period', 'description': 'Metrics of the percentage of planned baseline and follow-up survey ratings completed'}, {'measure': 'Participant Treatment Adherence', 'timeFrame': 'During the 6 months of the Navigator intervention period', 'description': 'Metrics of the percentage of referred Latino dementia dyads who attend at least 50% of Health Navigator visits'}, {'measure': 'Overall Participant Satisfaction With the Clinic Side of the Intervention', 'timeFrame': '6 months after baseline', 'description': "Survey question including a 5-item Likert scale on caregivers' satisfaction with clinic services (not at all to very much)"}, {'measure': 'Overall Participant Satisfaction With the Navigator Side of the Intervention', 'timeFrame': '6 months after baseline', 'description': 'Survey question to the caregiver including a 5-item Likert scale on satisfaction with Navigator services (not at all to very much)'}, {'measure': 'Participant Suggestions of Improvement', 'timeFrame': '6 months after baseline', 'description': 'Survey question to the caregiver including an open-ended question about which aspects of the intervention they would change'}, {'measure': 'Practitioner Adherence to Guideline Recommendations', 'timeFrame': '6 months after baseline', 'description': '10-item checklist administered to the dyads asking about the implementations of different aspects of dementia service guidelines'}], 'secondaryOutcomes': [{'measure': "Patients' Behavioral Symptoms", 'timeFrame': 'Baseline and 6 months from baseline', 'description': 'Brief version of the Neuropsychiatry Inventory Questionnaire: This is a validated clinical instrument for evaluating psychopathology in dementia. If any of the 12 neuropsychiatric symptoms is present, caregivers rate their loved one\'s severity on a three-point scale (mild-severe). For example, if the caregiver responds yes to "is the patient resistive to help from others at times, or hard to handle?", the following question would follow: "rate the severity of the symptom". An overall severity summary score is calculated by adding the severity scores of all items, ranging from 0 to 36, and higher scores mean higher severity.'}, {'measure': "Patients' Depression", 'timeFrame': 'Baseline and 6 months from baseline', 'description': 'Short Geriatric Depression Scale: This scale measures depressive symptomatology, and consists of 15 yes vs no questions. Of the 15 items, 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. A summary score is obtained ranging from 0 to 15, with higher scores meaning more severe depressive symptomatology.'}, {'measure': "Patients' Quality of Life", 'timeFrame': 'Baseline and 6 months from baseline', 'description': "Quality of Life in Alzheimer's Disease: The Quality of Life in Alzheimer's Disease is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better quality of life."}, {'measure': "Caregivers' Quality of Life", 'timeFrame': 'Baseline and 6 months from baseline', 'description': 'In general, how satisfied are you with your life?" with a 4-point scale from 1 (Very Satisfied) to 4 (Very Dissatisfied)'}, {'measure': "Caregivers' Depression", 'timeFrame': 'Baseline and 6 months from baseline', 'description': '10-item Center for Epidemiologic Studies-Depression scale (CES-D-10): This is a 10-item, self-report rating scale that measures characteristic symptoms of depression in the past week (e.g. depression, loneliness, restless sleep). Each item is rated on a 4-point scale, from 0 (rarely or none of the time) to 3 (most or all of the time) with positively worded items (items 5 and 8) reverse scored. Items yield summary scores that range from 0 to 30, with higher scores indicating higher severity. An example of an item is: "I was bothered by things that usually don\'t bother me"'}, {'measure': "Caregivers' Burden", 'timeFrame': 'Baseline and 6 months from baseline', 'description': 'Short Zarit Burden Interview: This caregiver burden scale has 6 items that address the perceived impact of the act of providing care on the physical health, emotional health, social activities and financial situation of the caregiver. Each item has five response options ranging from "never" to "nearly always". A total score is obtained by adding scores in all items, with a range from 0 to 24. Higher scores mean higher burden.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The research team will train primary care practitioners from Kansas City clinics to enhance skills in cultural competence, dementia detection, treatment and referral to a Health Navigator among Latinos 65 and older with dementia. The Health Navigator will provide patient/caregiver dyads referred by Alianza Latina providers with care management, psychosocial support and links to relevant community resources. Outcomes include feasibility and acceptability of 1) PCP training and 2) patient and caregiver dementia care.', 'detailedDescription': "Alzheimer's disease and related dementias (ADRD) are a major cause of mortality and disability in later life and cost the US healthcare system more than cancer or heart disease. The National Alzheimer's Plan Act and the National Institutes of Health have identified ADRD disparities among ethnic minorities as a public health priority. Latinos with ADRD experience substantial disparities with reduced rates of early diagnosis and lower quality care compared to their non-Latino white peers, which put them at an increased risk for steeper cognitive decline, morbidity, mortality and higher caregiver burden. A number of barriers conspire to create these disparities including a lack of an evidence-based strategy to address ADRD in clinics, patient and primary care provider (PCP) reduced ADRD knowledge, negative attitudes regarding ADRD, PCP's lack of time, cultural and language barriers and health insurance status. To improve healthcare delivery to Latinos with ADRD, researchers need to redesign current ADRD detection and care systems to follow evidence-based recommendations for early detection and culturally appropriate chronic care.\n\nThe overall aim of this proposal is to enhance the delivery of ADRD services to Latinos in primary care through a scalable systems approach that includes evidence-based recommendations. Primary care clinics are the ideal setting to provide ADRD services, as 93% of older Latinos have a usual source of healthcare. The novel systems approach (Alianza Latina/Latino Alliance) will enhance timely ADRD diagnosis and optimal care to minimize behavioral symptoms and cognitive decline among Latinos in a linguistically and culturally-appropriate way. Alianza Latina will use the Collaborative Care Framework that capitalizes on PCPs and Health Navigators. 1) PCPs will undergo evidence-based training to enhance timely and culturally appropriate diagnosis and implement it in their work routine. 2) PCPs will detect, treat and refer Latino ADRD patients to a bilingual Health Navigator to provide chronic care management, which will reduce PCP time burden.\n\nAim 2: Test the feasibility and acceptability of Alianza Latina. Aim 2.a: The research team will train PCPs from Kansas City clinics to enhance skills in cultural competence, ADRD detection, treatment and referral to a Health Navigator among Latinos 65 and older with ADRD. Aim 2.b. The Health Navigator will provide patients/caregiver dyads referred by Alianza Latina PCPs with care management, psychosocial support and links to relevant community resources. The research team will assess the feasibility and acceptability of 1) PCP training and 2) patient and caregiver ADRD care. Caregivers will be enrolled in a text messaging program, called CuidaTEXT, that will educate about memory and thinking problems, solve problems that are common among families with memory and thinking problems, send reminders for appointments and medications, and improve communication with the PCP, family, friends, and other resources."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for care recipients within the dyad:\n\n* Identify as Latino\n* Community dwelling\n* Diagnosed with mild cognitive impairment or dementia\n* Have a caregiver 18 years old or older\n* Have co-participant with access to a privately-owned cell phone with a flat fee for text messages\n\nInclusion Criteria for primary care providers:\n\n* Be 18 years old or older\n* Work as a primary care provider in the US\n\nExclusion Criteria for care recipients within the dyad:\n\n* Not identify as Latino\n* Not community dwelling\n* Not diagnosed with mild cognitive impairment or dementia\n* Not having a caregiver 18 years old or older\n* Not having a co-participant with access to a privately-owned cell phone with a flat fee for text messages\n\nExclusion Criteria for primary care providers:\n\n* Younger than 18 years old\n* Not work as a primary care provider in the US'}, 'identificationModule': {'nctId': 'NCT04418232', 'briefTitle': "Feasibility of a Systems Approach for Alzheimer's Services Among Latinos Attending Primary Care Practices", 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': "Feasibility of a Novel Systems Approach for Improving Utilization of Alzheimer's Disease Services Among Latinos Attending Primary Care Practices", 'orgStudyIdInfo': {'id': 'STUDY00145615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alianza Latina', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.', 'interventionNames': ['Combination Product: Alianza Latina']}], 'interventions': [{'name': 'Alianza Latina', 'type': 'COMBINATION_PRODUCT', 'description': 'The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.', 'armGroupLabels': ['Alianza Latina']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66103', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Jaime Perales Puchalt, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KUMC'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'February 1, 2025', 'ipdSharing': 'YES', 'description': "The final dataset will include patients' and caregivers' demographic and behavioral data from interviews as well as metrics and feasibility information provided by the primary care providers. Along with the dataset, we will create a code book documenting all variables. Study participants may find their diagnosis information potentially stigmatizing, and may prefer that these diagnoses remain entirely confidential. Although the data analytic files will not have direct identifiers (only study identification numbers), the possibility of deductive disclosure of subjects with certain clinical characteristics may remain. To safeguard against the unlikely event of deductive disclosure, we will only make the data files and codebook available to other researchers on a case-by-case basis.", 'accessCriteria': 'Researchers requesting data will need to complete a request form outlining intended use of the data, and agree to use the data solely for this intended purpose. Prior to data release, researchers requesting data will be required to sign a confidentiality agreement specifying that they will not identify any individual participant, that they will use secure technology to safeguard the data, and that they will destroy or return the data after their analyses are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}