NCT03864536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

July 29, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

February 28, 2019

Results QC Date

March 17, 2023

Last Update Submit

July 25, 2024

Conditions

Cognitive ChangeHealth BehaviorHealth Literacy

Outcome Measures

Primary Outcomes (1)

  • Leisure Activities Questionnaire Activities Sum

    The full measure is a 30-item survey asking about frequency of activities across 4 domains (cognitive, physical, social, and passive), in which higher scores reflect greater engagement in each type of activity (participants rate on Likert scale how often they perform each activity, 0=never/occasionally to 7=daily). The results below reflect a sum of cognitive, physical, and social activities (19 total activities). The total possible sum range is 0 to 133.

    change from baseline to 3 months

Secondary Outcomes (1)

  • Dementia Knowledge

    change from baseline to 3 months

Study Arms (3)

No-contact control

NO INTERVENTION

No-contact control

Psychoeducation control

ACTIVE COMPARATOR

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

Behavioral: Cognitive Prescriptions

Psychoeducation + CogRx

EXPERIMENTAL

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

Interventions

Cognitive PrescriptionsBEHAVIORAL

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.

Also known as: CogRx
Psychoeducation + CogRxPsychoeducation control

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

the Holly Mears Building/Center for Research on Applied Gerontology

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

    PMID: 37463839DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Pariya Wheeler
Organization
UAB
plfazeli@uab.edu
2052423924

Study Officials

  • Pariya Wheeler

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 6, 2019

Study Start

January 1, 2020

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

July 29, 2024

Results First Posted

July 29, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)