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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Health Behavior; Health Literacy
• Intervention / Treatment: Behavioral: Cognitive Prescriptions

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • the Holly Mears Building/Center for Research on Applied Gerontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No-contact control
Active Comparator: Psychoeducation control; Receives general psychoeducation on dementia prevalence, prognosis, and risk factors,	Behavioral: 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.; Other Names: CogRx
Experimental: 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.	Behavioral: 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.; Other Names: CogRx

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Pariya Wheeler, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: Cognitive Prescriptions

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No