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Clinical Trials/NCT03864536
NCT03864536CompletedNot Applicable

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

University of Alabama at Birmingham2 sites in 1 country39 target enrollmentStarted: January 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
39
Locations
2
Primary Endpoint
Leisure Activities Questionnaire Activities Sum

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Leisure Activities Questionnaire Activities Sum

Time Frame: change from baseline to 3 months

The full measure is a 30-item survey asking about frequency of activities across 4 domains (cognitive, physical, social, and passive), in which higher scores reflect greater engagement in each type of activity (participants rate on Likert scale how often they perform each activity, 0=never/occasionally to 7=daily). The results below reflect a sum of cognitive, physical, and social activities (19 total activities). The total possible sum range is 0 to 133.

Secondary Outcomes

  • Dementia Knowledge(change from baseline to 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pariya L. Fazeli, PhD

Assistant Professor

University of Alabama at Birmingham

Study Sites (2)

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