A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions

Study Overview
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Brief Summary
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The goal of this R21 study is to explore the feasibility and preliminary efficacy of individualized cognitive prescriptions (CogRxs) in improving engagement in healthy behaviors and other outcomes in middle-aged AAs and to gain feedback on future implementation of the program.

Detailed Description
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A pre-post experimental design will be used, in which 150 AA participants aged 50-65 will complete a baseline assessment of cognitive testing and data-driven assessment of deficiencies across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity). Participants will be randomized to either: psychoeducation + CogRx, psychoeducation only, or no contact control. The psychoeducation and CogRx groups will receive general psychoeducation on dementia prevalence, prognosis, and risk factors, while the CogRx group will also receive personalized information on their risk factor profile and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home. Motivational reminders as well as adherence and self-efficacy questions will be administered via text-messaging over the 3-months. Participants will return for 3-month and 6-month follow-ups. Specific Aim 1 (proximal outcomes) is to determine whether the CogRx condition is superior to psychoeducation alone in improving engagement in healthy lifestyle behaviors. Specific Aim 2 (distal outcomes) is to compare the three conditions on a brief battery of cognitive and psychological measures. The Exploratory Aim is to gather feedback for future implementation of this program, including cultural considerations, barriers and facilitators to engagement, and likelihood of continuing the program.

Official Title
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A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions

Conditions
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Cognitive Change, Health Behavior, Health Literacy

Intervention / Treatment
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* Behavioral: Cognitive Prescriptions


Participation Criteria
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Eligibility Criteria
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Inclusions: Must be African American Must be age 50 to 65 Must have a working cell phone with unlimited texting Must be ambulatory Exclusions: No neurological (including dementia diagnosis) or severe psychiatric (e.g., schizophrenia or bipolar disorder) disorders No insomnia Telephone Interview for Cognitive Status (TICS) score ≤20

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A pre-post experimental design will be used, in which 150 AA participants aged 50-65 will complete a baseline assessment of cognitive testing and data-driven assessment of deficiencies across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity). Participants will be randomized to either: psychoeducation + CogRx, psychoeducation only, or no-contact control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No-contact control<br>No-contact control | |
| Active Comparator: Psychoeducation control<br>Receives general psychoeducation on dementia prevalence, prognosis, and risk factors, | Behavioral: Cognitive Prescriptions<br>* Personalized information on their risk factor profile across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity) and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home.<br>* Other names: CogRx;|
| Experimental: Psychoeducation + CogRx<br>Receives same general psychoeducation on dementia and will also receive personalized information on their risk factor profile and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home. | Behavioral: Cognitive Prescriptions<br>* Personalized information on their risk factor profile across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity) and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home.<br>* Other names: CogRx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Behavior Composite Score | Physical activity, cognitive activity, diet, sleep, and social activity are the primary outcome, as the goal of the intervention is to improve behaviors the participant is determined to have deficiencies in at baseline. Since the intervention is tailored, outcomes are unique (e.g., one persons intervention might consist of improving physical activity and diet, whereas another might focus on cognitive activity and sleep). The following self-reported questionnaires will be used: Physical activity (the International Physical Activity Questionnaire), Diet (the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) questionnaire), Social Activity (the Duke Social Support Inventory), Sleep (the Pittsburg Sleep Quality Index (PSQI)), Cognitive Activity (a modified Florida Cognitive Activities Scale). Cutoffs will be used to create dichotomies for each domain such that 1=optimal and 0=suboptimal, which will be summed to create a Health Behavior composite (scores ranging from 0-5). | change from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dementia Knowledge | Scores on the Dementia Knowledge Assessment Scale (DKAS-27) which assesses knowledge about risk factors and prognosis of dementia. Scores include percentage correct for the 27 items, with scores ranging from 0-100%. | change from baseline to 3 months |