Cognitive ChangeNCT03864536
A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions
A study testing Cognitive Prescriptions in people with Cognitive Change and Health Behavior, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Health Behavior, Health Literacy
- What is being tested?
- Cognitive Prescriptions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
the Holly Mears Building/Center for Research on Applied Gerontology
Birmingham, Alabama, 35294
About this study
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.
Read the 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.
- Conditions
- Cognitive Change, Health Behavior, Health Literacy
- Being tested
- Cognitive Prescriptions
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive PrescriptionsBehavioural
Also called CogRx
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.
| Study group | Role | What they receive |
|---|---|---|
| No-contact control | No intervention | No-contact control |
| Psychoeducation control | Active comparator | Receives general psychoeducation on dementia prevalence, prognosis, and risk factors, Receives: 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. Receives: Behavioral: Cognitive Prescriptions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to 3 months
Secondary outcomes (1)
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%. There are 27 items and each item is scored as correct or incorrect. Therefore the scores include a percentage of total items correct, ranging from 0-100 with higher meaning better knowledge.
Measured: change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Jan 2020
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pariya L. Fazeli, PhD, University of Alabama at Birmingham
- Investigators
- Pariya Wheeler, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864536
- Sponsor's protocol ID
- Cognitive Prescriptions
- Status last verified
- Jul 2024
- First submitted
- 28 Feb 2019
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37463839
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions
- ClinicalTrials.gov ID
- NCT03864536
- Acronym / sponsor ID
- Cognitive Prescriptions
- Conditions
- Cognitive Change, Health Behavior, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| No-contact control | No intervention | –No-contact control |
| Psychoeducation control | Active comparator | Behavioral: Cognitive PrescriptionsReceives general psychoeducation on dementia prevalence, prognosis, and risk factors, |
| Psychoeducation + CogRx | Experimental | Behavioral: Cognitive PrescriptionsReceives 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive PrescriptionsAlso: CogRxPersonalized 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. | Behavioural | Psychoeducation + CogRx, Psychoeducation control |
Primary outcome
Leisure Activities Questionnaire Activities Sum
Time frame: change from baseline to 3 months
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.
1 secondary outcome
Dementia Knowledge
Time frame: change from baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37463839Fazeli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pariya Wheeler principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Prescriptions in people with Cognitive Change and Health Behavior, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leisure Activities Questionnaire Activities Sum (time frame: change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.