Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-08 @ 11:16 AM
Study NCT ID:
NCT03683394
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2018-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Systematic Multi-domain Alzheimer's Risk Reduction Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], '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'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kristine.yaffe@ucsf.edu', 'phone': '(415) 476-7307', 'title': 'Dr. Kristine Yaffe', 'organization': 'The University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Our trial was initiated prior to the COVID-19 pandemic, but the shutdown shortened the enrollment period and necessitated administering the intervention and measuring the outcomes remotely.'}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': '1. Main Ascertainment: All participants are asked to report hospitalizations, new serious medical conditions, and new serious disabilities every three months, via AE form. This constitutes systematic assessment.\n2. Additional Reporting: Participants randomized to the intervention arm report incidental AEs during their coaching visits and phone calls. This constitutes non-systematic assessment. All possibly related, non-serious AEs are listed.\n\nNone of the SAEs are study related.', 'eventGroups': [{'id': 'EG000', 'title': 'SMARRT Intervention', 'description': "The SMARRT intervention team used a standardized procedure to develop an individualized Alzheimer's risk profile for each participant randomized to the SMARRT intervention arm. Participants then met with an interventionist to review their risk profile and develop an initial personalized risk reduction action plan. Targeted areas included: increasing physical, mental and social activities; quitting smoking; healthy diet; controlling cardiovascular risk factors (diabetes, hypertension), including avoiding hypoglycemia in people with diabetes; reducing depressive symptoms; improving sleep; and decreasing use of potentially harmful medications.\n\nSMARRT Intervention: Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period.", 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 14, 'seriousNumAtRisk': 82, 'deathsNumAffected': 3, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Health Education Control', 'description': "Participants in the Health Education arm were mailed general information that addressed factors targeted in the SMARRT intervention, including physical, mental and social engagement; management of cardiovascular risk factors; quitting smoking, healthy diet; depression; sleep; and contraindicated medications. HE participants were not provided with personalized information about their risk of Alzheimer's and dementia.\n\nHealth Education Intervention: Participants randomized to the Health Education (HE) group received mailed materials (typically 1-2 pages) every 3 months. This included general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA).", 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 0, 'seriousNumAtRisk': 90, 'deathsNumAffected': 1, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Non-Serious, Possibly Related', 'notes': 'Calf cramps, joint pain, muscle pulls', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Serious, Possibly Related', 'notes': 'Study-related anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Serious, Possibly Related', 'notes': 'High blood pressure at study visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-serious, Possibly Related', 'notes': 'Rash from activity monitor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Life-Threatening Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Life-Threatening Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cognitive Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMARRT Intervention', 'description': "The SMARRT intervention team used a standardized procedure to develop an individualized Alzheimer's risk profile for each participant randomized to the SMARRT intervention arm. Participants then met with an interventionist to review their risk profile and develop an initial personalized risk reduction action plan. Targeted areas included: increasing physical, mental and social activities; quitting smoking; healthy diet; controlling cardiovascular risk factors (diabetes, hypertension), including avoiding hypoglycemia in people with diabetes; reducing depressive symptoms; improving sleep; and decreasing use of potentially harmful medications.\n\nSMARRT Intervention: Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period."}, {'id': 'OG001', 'title': 'Health Education Control', 'description': "Participants in the Health Education arm were mailed general information that addressed factors targeted in the SMARRT intervention, including physical, mental and social engagement; management of cardiovascular risk factors; quitting smoking, healthy diet; depression; sleep; and contraindicated medications. HE participants were not provided with personalized information about their risk of Alzheimer's and dementia.\n\nHealth Education Intervention: Participants randomized to the Health Education (HE) group received mailed materials (typically 1-2 pages) every 3 months. This included general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA)."}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.42'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.26'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.26', 'pValueComment': 'Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.'}], 'paramType': 'MEAN', 'timeFrame': '2 Years', 'description': 'Cognitive function will be measured by the modified Neuropsychological Test Battery (mNTB) global score, which is a composite z-score, an average of z-scores from tests of several cognitive domains. The total score is reported. Higher values signify higher cognitive performance. A z-score of 0 represents the population mean.\n\nTreatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment (6, 12, 18, and 24 months), with average treatment effects (ATEs) estimated by the average of the four visit-specific between-group differences in adjusted mean change from baseline.\n\nChanges made to the protocol due to Covid-19, i.e., switching to telephone data collection, will likely limit our ability to examine cognitive change effectively, as several of the most important cognitive tests cannot be administered via telephone.', 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were all members of Kaiser Permanente Washington (KPWA), an integrated healthcare delivery system in the Seattle area. Eligible participants were KPWA members aged 70-89, who had at least two of the following dementia risk factors targeted by the intervention: physical inactivity, uncontrolled hypertension, poor sleep, taking a prescription medication that may adversely affect cognition, high depressive symptoms, uncontrolled diabetes, social isolation, and current smoking.'}, {'type': 'SECONDARY', 'title': 'Change in Targeted Risk Factors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMARRT Intervention', 'description': "The SMARRT intervention team used a standardized procedure to develop an individualized Alzheimer's risk profile for each participant randomized to the SMARRT intervention arm. Participants then met with an interventionist to review their risk profile and develop an initial personalized risk reduction action plan. Targeted areas included: increasing physical, mental and social activities; quitting smoking; healthy diet; controlling cardiovascular risk factors (diabetes, hypertension), including avoiding hypoglycemia in people with diabetes; reducing depressive symptoms; improving sleep; and decreasing use of potentially harmful medications.\n\nSMARRT Intervention: Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period."}, {'id': 'OG001', 'title': 'Health Education Control', 'description': "Participants in the Health Education arm were mailed general information that addressed factors targeted in the SMARRT intervention, including physical, mental and social engagement; management of cardiovascular risk factors; quitting smoking, healthy diet; depression; sleep; and contraindicated medications. HE participants were not provided with personalized information about their risk of Alzheimer's and dementia.\n\nHealth Education Intervention: Participants randomized to the Health Education (HE) group received mailed materials (typically 1-2 pages) every 3 months. This included general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA)."}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '-0.01', 'upperLimit': '0.13'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.12', 'upperLimit': '0.02'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.21', 'pValueComment': 'Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.'}], 'paramType': 'MEAN', 'timeFrame': '2 Years', 'description': 'A composite Z-score for risk factors based on the following: the Rapid Assessment of Physical Activity for Older Adult (RAPA), steps per day averaged over 7 days; blood pressure measures averaged for each six-month period for participants with hypertension; the Pittsburgh Sleep Quality Index (PSQI); use of potentially harmful prescription medications; the Center for Epidemiologic Studies - Depression Scale (CES-D); hemoglobin A1c (HbA1c) values averaged over a 12-month time period; the Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Activities, Short Form; and self-reported smoking. Higher score indicates greater risk factor burden. A z-score of 0 represents the population mean.\n\nTreatment effects were estimated using LMMs for the changes from baseline to each follow-up assessment (6, 12, 18, and 24 months), with ATEs estimated by the average of the four visit-specific between-group differences in adjusted mean change from baseline.', 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were all members of Kaiser Permanente Washington (KPWA), an integrated healthcare delivery system in the Seattle area. Eligible participants were KPWA members aged 70-89, who had at least two of the following dementia risk factors targeted by the intervention: physical inactivity, uncontrolled hypertension, poor sleep, taking a prescription medication that may adversely affect cognition, high depressive symptoms, uncontrolled diabetes, social isolation, and current smoking.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMARRT Intervention', 'description': "The SMARRT intervention team used a standardized procedure to develop an individualized Alzheimer's risk profile for each participant randomized to the SMARRT intervention arm. Participants then met with an interventionist to review their risk profile and develop an initial personalized risk reduction action plan. Targeted areas included: increasing physical, mental and social activities; quitting smoking; healthy diet; controlling cardiovascular risk factors (diabetes, hypertension), including avoiding hypoglycemia in people with diabetes; reducing depressive symptoms; improving sleep; and decreasing use of potentially harmful medications.\n\nSMARRT Intervention: Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period."}, {'id': 'OG001', 'title': 'Health Education Control', 'description': "Participants in the Health Education arm were mailed general information that addressed factors targeted in the SMARRT intervention, including physical, mental and social engagement; management of cardiovascular risk factors; quitting smoking, healthy diet; depression; sleep; and contraindicated medications. HE participants were not provided with personalized information about their risk of Alzheimer's and dementia.\n\nHealth Education Intervention: Participants randomized to the Health Education (HE) group received mailed materials (typically 1-2 pages) every 3 months. This included general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA)."}], 'classes': [{'categories': [{'measurements': [{'value': '12.69', 'groupId': 'OG000', 'lowerLimit': '9.44', 'upperLimit': '15.93'}, {'value': '11.58', 'groupId': 'OG001', 'lowerLimit': '8.36', 'upperLimit': '14.79'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.08', 'ciUpperLimit': '2.14', 'pValueComment': 'Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.'}], 'paramType': 'MEAN', 'timeFrame': '2 Years', 'description': 'Measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. Higher score indicates better global health and quality of life; range = 0 to 20.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were all members of Kaiser Permanente Washington (KPWA), an integrated healthcare delivery system in the Seattle area. Eligible participants were KPWA members aged 70-89, who had at least two of the following dementia risk factors targeted by the intervention: physical inactivity, uncontrolled hypertension, poor sleep, taking a prescription medication that may adversely affect cognition, high depressive symptoms, uncontrolled diabetes, social isolation, and current smoking.'}, {'type': 'SECONDARY', 'title': "Number of Participants With Mild Cognitive Impairment, Alzheimer's Disease, and Dementia", 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMARRT Intervention', 'description': "The SMARRT intervention team used a standardized procedure to develop an individualized Alzheimer's risk profile for each participant randomized to the SMARRT intervention arm. Participants then met with an interventionist to review their risk profile and develop an initial personalized risk reduction action plan. Targeted areas included: increasing physical, mental and social activities; quitting smoking; healthy diet; controlling cardiovascular risk factors (diabetes, hypertension), including avoiding hypoglycemia in people with diabetes; reducing depressive symptoms; improving sleep; and decreasing use of potentially harmful medications.\n\nSMARRT Intervention: Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period."}, {'id': 'OG001', 'title': 'Health Education Control', 'description': "Participants in the Health Education arm were mailed general information that addressed factors targeted in the SMARRT intervention, including physical, mental and social engagement; management of cardiovascular risk factors; quitting smoking, healthy diet; depression; sleep; and contraindicated medications. HE participants were not provided with personalized information about their risk of Alzheimer's and dementia.\n\nHealth Education Intervention: Participants randomized to the Health Education (HE) group received mailed materials (typically 1-2 pages) every 3 months. This included general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA)."}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.19', 'ciUpperLimit': '2.19', 'pValueComment': 'Adjusted for age and sex.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'In an exploratory outcome, we examined incidence of a low CASI score or a diagnosis of MCI or dementia by treatment group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 Years', 'description': "Number of participants at follow up visits with Mild Cognitive Impairment, Alzheimer's Disease, and/or Dementia or with a low score on the Cognitive Abilities Screening Instrument (CASI) (\\<27 consistent with cognitive impairment). Lower score indicates poorer cognition; range is 0-33.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were all members of Kaiser Permanente Washington (KPWA), an integrated healthcare delivery system in the Seattle area. Eligible participants were KPWA members aged 70-89, who had at least two of the following dementia risk factors targeted by the intervention: physical inactivity, uncontrolled hypertension, poor sleep, taking a prescription medication that may adversely affect cognition, high depressive symptoms, uncontrolled diabetes, social isolation, and current smoking.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SMARRT Intervention', 'description': "The SMARRT intervention team used a standardized procedure to develop an individualized Alzheimer's risk profile for each participant randomized to the SMARRT intervention arm. Participants then met with an interventionist to review their risk profile and develop an initial personalized risk reduction action plan. Targeted areas included: increasing physical, mental and social activities; quitting smoking; healthy diet; controlling cardiovascular risk factors (diabetes, hypertension), including avoiding hypoglycemia in people with diabetes; reducing depressive symptoms; improving sleep; and decreasing use of potentially harmful medications.\n\nSMARRT Intervention: Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period."}, {'id': 'FG001', 'title': 'Health Education Control', 'description': "Participants in the Health Education arm were mailed general information that addressed factors targeted in the SMARRT intervention, including physical, mental and social engagement; management of cardiovascular risk factors; quitting smoking, healthy diet; depression; sleep; and contraindicated medications. HE participants were not provided with personalized information about their risk of Alzheimer's and dementia.\n\nHealth Education Intervention: Participants randomized to the Health Education (HE) group received mailed materials (typically 1-2 pages) every 3 months. This included general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SMARRT Intervention', 'description': "The SMARRT intervention team used a standardized procedure to develop an individualized Alzheimer's risk profile for each participant randomized to the SMARRT intervention arm. Participants then met with an interventionist to review their risk profile and develop an initial personalized risk reduction action plan. Targeted areas included: increasing physical, mental and social activities; quitting smoking; healthy diet; controlling cardiovascular risk factors (diabetes, hypertension), including avoiding hypoglycemia in people with diabetes; reducing depressive symptoms; improving sleep; and decreasing use of potentially harmful medications.\n\nSMARRT Intervention: Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period."}, {'id': 'BG001', 'title': 'Health Education Control', 'description': "Participants in the Health Education arm were mailed general information that addressed factors targeted in the SMARRT intervention, including physical, mental and social engagement; management of cardiovascular risk factors; quitting smoking, healthy diet; depression; sleep; and contraindicated medications. HE participants were not provided with personalized information about their risk of Alzheimer's and dementia.\n\nHealth Education Intervention: Participants randomized to the Health Education (HE) group received mailed materials (typically 1-2 pages) every 3 months. This included general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA)."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '75.6', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '75.7', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education, years', 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '16.4', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '16.2', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Years of formal education completed. For example, 12 years = High School Graduate.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Elixhauser comorbidity score', 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Elixhauser Comorbidity Index (Elixhauser, 1998) is a risk score that measures the overall severity of comorbid illnesses (using diagnostic codes). Scores can range from 0 to 31. Higher scores represent higher severity of comorbid illnesses in the year prior to baseline and are associated with higher risk of mortality and hospital resource use.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Risk Factors', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Average number of risk factors present at baseline, out of a total of 8 risk factors.', 'unitOfMeasure': 'Risk Factors', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-26', 'size': 582233, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-26T16:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized after baseline assessments to the SMARRT intervention arm or Health Education (HE) control arm. Randomization will be stratified by clinic, race/ethnicity (non-Hispanic white vs. non-white or Hispanic) and age (70-79, 80-89).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2018-09-20', 'resultsFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2018-09-21', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-24', 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Change', 'timeFrame': '2 Years', 'description': 'Cognitive function will be measured by the modified Neuropsychological Test Battery (mNTB) global score, which is a composite z-score, an average of z-scores from tests of several cognitive domains. The total score is reported. Higher values signify higher cognitive performance. A z-score of 0 represents the population mean.\n\nTreatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment (6, 12, 18, and 24 months), with average treatment effects (ATEs) estimated by the average of the four visit-specific between-group differences in adjusted mean change from baseline.\n\nChanges made to the protocol due to Covid-19, i.e., switching to telephone data collection, will likely limit our ability to examine cognitive change effectively, as several of the most important cognitive tests cannot be administered via telephone.'}], 'secondaryOutcomes': [{'measure': 'Change in Targeted Risk Factors', 'timeFrame': '2 Years', 'description': 'A composite Z-score for risk factors based on the following: the Rapid Assessment of Physical Activity for Older Adult (RAPA), steps per day averaged over 7 days; blood pressure measures averaged for each six-month period for participants with hypertension; the Pittsburgh Sleep Quality Index (PSQI); use of potentially harmful prescription medications; the Center for Epidemiologic Studies - Depression Scale (CES-D); hemoglobin A1c (HbA1c) values averaged over a 12-month time period; the Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Activities, Short Form; and self-reported smoking. Higher score indicates greater risk factor burden. A z-score of 0 represents the population mean.\n\nTreatment effects were estimated using LMMs for the changes from baseline to each follow-up assessment (6, 12, 18, and 24 months), with ATEs estimated by the average of the four visit-specific between-group differences in adjusted mean change from baseline.'}, {'measure': 'Quality of Life Measure', 'timeFrame': '2 Years', 'description': 'Measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. Higher score indicates better global health and quality of life; range = 0 to 20.'}, {'measure': "Number of Participants With Mild Cognitive Impairment, Alzheimer's Disease, and Dementia", 'timeFrame': '2 Years', 'description': "Number of participants at follow up visits with Mild Cognitive Impairment, Alzheimer's Disease, and/or Dementia or with a low score on the Cognitive Abilities Screening Instrument (CASI) (\\<27 consistent with cognitive impairment). Lower score indicates poorer cognition; range is 0-33."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Alzheimer Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Alzheimer's Disease International. World Alzheimer Report 2015: The Global Impact of Dementia, An Analysis of Prevalence, Incidence, Cost and Trends. London: Alzheimer's Disease International (ADI); 2015."}, {'pmid': '21414557', 'type': 'BACKGROUND', 'citation': "Alzheimer's Association. 2011 Alzheimer's disease facts and figures. Alzheimers Dement. 2011 Mar;7(2):208-44. doi: 10.1016/j.jalz.2011.02.004."}, {'pmid': '29318278', 'type': 'BACKGROUND', 'citation': 'Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. 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Hillsdale, N.J.: Lawrence Earlbaum Associates; 1988.'}, {'pmid': '17397440', 'type': 'BACKGROUND', 'citation': 'Li C, Friedman B, Conwell Y, Fiscella K. Validity of the Patient Health Questionnaire 2 (PHQ-2) in identifying major depression in older people. J Am Geriatr Soc. 2007 Apr;55(4):596-602. doi: 10.1111/j.1532-5415.2007.01103.x.'}, {'pmid': '18752852', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.'}, {'pmid': '38010725', 'type': 'DERIVED', 'citation': 'Yaffe K, Vittinghoff E, Dublin S, Peltz CB, Fleckenstein LE, Rosenberg DE, Barnes DE, Balderson BH, Larson EB. Effect of Personalized Risk-Reduction Strategies on Cognition and Dementia Risk Profile Among Older Adults: The SMARRT Randomized Clinical Trial. JAMA Intern Med. 2024 Jan 1;184(1):54-62. doi: 10.1001/jamainternmed.2023.6279.'}]}, 'descriptionModule': {'briefSummary': "The primary goal of this randomized controlled trial (RCT) is to pilot-test a personalized, pragmatic, multi-domain Alzheimer's disease risk reduction intervention in a U.S. integrated healthcare delivery system.", 'detailedDescription': "We propose to randomize 200 higher-risk older adults (age 70-89 with low-normal performance on cognitive testing and 2+ modifiable risk factors that will be targeted by our intervention) to a two-year Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT) intervention or a Health Education (HE) control.\n\nThe SMARRT team will work with participants randomized to the intervention arm to develop a tailored action plan to address risk reduction. Targeted areas will include: increasing physical, mental and social activities; controlling cardiovascular risk factors (diabetes, hypertension); quitting smoking; reducing depressive symptoms; improving sleep; neuroprotective diet; and decreasing use of potentially harmful medications. HE participants will receive periodic handouts on these topics by mail.\n\nChanges made to the protocol due to COVID-19, i.e. switching to telephone data collection, will likely limit our ability to examine cognitive change effectively, as several of the most important cognitive tests cannot be administered via telephone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 70-89 Years of Age\n* Fluent in the English Language\n* Low-normal performance on a brief telephone cognitive screen, measured using the Cognitive Abilities Screening Instruments (CASI). Low-normal scores are defined as 26-29.\n* Has at least two additional risk factors that will be targeted by the intervention.\n\nExclusion Criteria:\n\n* Residing in a skilled nursing or rehabilitation facility\n* Receiving palliative care or hospice services\n* Charlson comorbidity index score of greater than 5\n* Bipolar illness or schizophrenia\n* Current alcohol or drug use disorder\n* Receiving chronic opioid therapy\n* Parkinson's disease, amyotrophic lateral sclerosis, or multiple sclerosis\n* Severe visual or hearing impairment\n* Requests not to be contacted or not to have their medical record reviewed for research\n* Prior evidence of dementia"}, 'identificationModule': {'nctId': 'NCT03683394', 'acronym': 'SMARRT', 'briefTitle': "Systematic Multi-domain Alzheimer's Risk Reduction Trial", 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot', 'orgStudyIdInfo': {'id': '1R01AG057508', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG057508', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SMARRT Intervention', 'description': "The SMARRT intervention team will use a standardized procedure to develop an individualized Alzheimer's risk profile for each participant randomized to the SMARRT intervention arm. Participants will then meet in-person with an interventionist to review their risk profile and develop an initial personalized risk reduction action plan. For the few participants enrolled during COVID, initial interventionist visits were conducted by phone. Targeted areas will include: increasing physical, mental and social activities; quitting smoking; healthy diet; controlling cardiovascular risk factors (diabetes, hypertension), including avoiding hypoglycemia in people with diabetes; reducing depressive symptoms; improving sleep; and decreasing use of potentially harmful medications.", 'interventionNames': ['Behavioral: SMARRT Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education Intervention', 'description': "Participants in the Health Education arm will be mailed general information that will address factors that will be targeted in the SMARRT intervention, including physical, mental and social engagement; management of cardiovascular risk factors; quitting smoking, healthy diet; depression; sleep; and contraindicated medications. HE participants will not be provided with personalized information about their risk of Alzheimer's and dementia.", 'interventionNames': ['Behavioral: Health Education Intervention']}], 'interventions': [{'name': 'SMARRT Intervention', 'type': 'BEHAVIORAL', 'description': 'Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period.', 'armGroupLabels': ['SMARRT Intervention']}, {'name': 'Health Education Intervention', 'type': 'BEHAVIORAL', 'description': "Participants randomized to the Health Education (HE) group will receive mailed materials (typically 1-2 pages) every 3 months. This will include general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA).", 'armGroupLabels': ['Health Education Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Washington Health Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Sascha Dublin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}, {'name': 'Kristine Yaffe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}