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

NCT ID: NCT03864536

Last Updated: 2024-07-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-30

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.

Conditions

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Cognitive Change Health Behavior Health Literacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No-contact control

No-contact control

Group Type NO_INTERVENTION

No interventions assigned to this group

Psychoeducation control

Receives general psychoeducation on dementia prevalence, prognosis, and risk factors,

Group Type ACTIVE_COMPARATOR

Cognitive Prescriptions

Intervention Type BEHAVIORAL

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.

Psychoeducation + CogRx

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.

Group Type EXPERIMENTAL

Cognitive Prescriptions

Intervention Type BEHAVIORAL

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.

Interventions

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Cognitive Prescriptions

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CogRx

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Pariya L. Fazeli, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pariya Wheeler

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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the Holly Mears Building/Center for Research on Applied Gerontology

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Fazeli PL, Hopkins C, Vance DE, Wadley V, Li P, Turan B, Wang DH, Bowen PG, Clay OJ. Cognitive prescriptions for reducing dementia risk factors among Black/African Americans: feasibility, acceptability, and preliminary efficacy. Ethn Health. 2024 Jan;29(1):1-24. doi: 10.1080/13557858.2023.2231669. Epub 2023 Jul 18.

Reference Type DERIVED
PMID: 37463839 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Cognitive Prescriptions

Identifier Type: -

Identifier Source: org_study_id

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