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

Primary Purpose

Cognitive Change, Health Behavior, Health Literacy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Prescriptions
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Change

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • the Holly Mears Building/Center for Research on Applied Gerontology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

No-contact control

Psychoeducation control

Psychoeducation + CogRx

Arm Description

No-contact control

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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%.

Full Information

First Posted
February 28, 2019
Last Updated
November 30, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03864536
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Health Behavior, Health Literacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No-contact control
Arm Type
No Intervention
Arm Description
No-contact control
Arm Title
Psychoeducation control
Arm Type
Active Comparator
Arm Description
Receives general psychoeducation on dementia prevalence, prognosis, and risk factors,
Arm Title
Psychoeducation + CogRx
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Prescriptions
Other Intervention Name(s)
CogRx
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Behavior Composite Score
Description
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).
Time Frame
change from baseline to 3 months
Secondary Outcome Measure Information:
Title
Dementia Knowledge
Description
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%.
Time Frame
change from baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pariya Wheeler
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Holly Mears Building/Center for Research on Applied Gerontology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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