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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864536
• Other study ID #: Cognitive Prescriptions
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: November 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Dementia
• Health Behavior
• Health Literacy

Intervention

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.

Locations

Country	Name	City	State
United States	the Holly Mears Building/Center for Research on Applied Gerontology	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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