Clinical trial NCT03864536: A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions
Official title: A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Health Behavior
Health Literacy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 39
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Leisure Activities Questionnaire Activities Sum
timeFrame: change from baseline to 3 months
Secondary outcomes:
measure: Dementia Knowledge
timeFrame: change from baseline to 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: the Holly Mears Building/Center for Research on Applied Gerontology
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Pariya Wheeler
role: PRINCIPAL_INVESTIGATOR
References: