Trial Outcomes & Findings for A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions (NCT NCT03864536)
NCT ID: NCT03864536
Last Updated: 2024-07-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
change from baseline to 3 months
Results posted on
2024-07-29
Participant Flow
Participant milestones
| Measure |
No-contact Control
No-contact control, has no contact for 3 months
|
Psychoeducation Control
Receives general psychoeducation on dementia prevalence, prognosis, and risk factors
|
Psychoeducation + CogRx
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.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
13
|
|
Overall Study
COMPLETED
|
14
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multidomain Approach to Preventing Dementia in African Americans: Cognitive Prescriptions
Baseline characteristics by cohort
| Measure |
No-contact Control
n=14 Participants
No-contact control, no contact for 3 months
|
Psychoeducation Control
n=12 Participants
Receives general psychoeducation on dementia prevalence, prognosis, and risk factors.
|
Psychoeducation + CogRx
n=13 Participants
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.
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.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
56.08 years
STANDARD_DEVIATION 5.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
TICS-telephone interview for cognitive status
|
35.2 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
33.4 units on a scale
STANDARD_DEVIATION 3.4 • n=7 Participants
|
35.2 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
34.67 units on a scale
STANDARD_DEVIATION 3.55 • n=4 Participants
|
|
Marital Status
In relationship
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Marital Status
Single, Divorced, or Widowed
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Employment Status
Working full or part time
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Employment Status
Not working (unemployed, retired, on disability)
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: change from baseline to 3 monthsThe 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.
Outcome measures
| Measure |
No-contact Control
n=13 Participants
No-contact control, no contact for 3 months
|
Psychoeducation Control
n=10 Participants
Receives general psychoeducation on dementia prevalence, prognosis, and risk factors.
|
Psychoeducation + CogRx
n=12 Participants
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.
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.
|
|---|---|---|---|
|
Leisure Activities Questionnaire Activities Sum
|
1.45 score on a scale
Interval -5.41 to 8.32
|
4.45 score on a scale
Interval -3.23 to 12.14
|
11.25 score on a scale
Interval 4.1 to 18.4
|
SECONDARY outcome
Timeframe: change from baseline to 3 monthsScores 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.
Outcome measures
| Measure |
No-contact Control
n=13 Participants
No-contact control, no contact for 3 months
|
Psychoeducation Control
n=10 Participants
Receives general psychoeducation on dementia prevalence, prognosis, and risk factors.
|
Psychoeducation + CogRx
n=12 Participants
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.
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.
|
|---|---|---|---|
|
Dementia Knowledge
|
10 score on a scale
Interval 1.0 to 19.0
|
27 score on a scale
Interval 16.0 to 37.0
|
19 score on a scale
Interval 9.0 to 28.0
|
Adverse Events
No-contact Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychoeducation Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychoeducation + CogRx
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place