Trial Outcomes & Findings for Efficacy of a Multimodal Brain Health Intervention for Older African Americans (NCT NCT04863378)
NCT ID: NCT04863378
Last Updated: 2025-01-06
Results Overview
Daily steps are recorded on a continuously worn actigraphy watch (Withings), which measures 24-hour activity (gross motor activity).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-01-06
Participant Flow
Participants of the Community Stakeholder Interviewees group are identified via a consultation between the study team and representatives from UC Davis Alzheimer's Disease Center and the AAMLO
Participant milestones
| Measure |
Cognitively Healthy Participants
Participants were Black/African American adults aged 65 or over who are cognitively healthy according to a baseline Montreal Cognitive Assessment score of 24 or higher. Participants continuously wore an actigraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
|
Mildly Cognitively Impaired (MCI) Participants
Participants were Black/African American adults aged 65 or over who are mildly cognitively impaired according to a baseline Montreal Cognitive Assessment score below 24. Participants continuously wore an actigraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
|
Community Stakeholder Interviewees
Participants were Black/African American adults aged 55 and over who were individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of a Multimodal Brain Health Intervention for Older African Americans
Baseline characteristics by cohort
| Measure |
Cognitively Healthy Participants
n=4 Participants
Participants were Black/African American adults aged 65 or over who are cognitively healthy according to a baseline Montreal Cognitive Assessment score of 24 or higher. Participants continuously wore an actigraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
|
Mildly Cognitively Impaired (MCI) Participants
n=5 Participants
Participants were Black/African American adults aged 65 or over who are mildly cognitively impaired according to a baseline Montreal Cognitive Assessment score below 24. Participants continuously wore an actigraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
|
Community Stakeholder Interviewees
n=4 Participants
Participants were Black/African American adults aged 55 and over were individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 4.64 • n=5 Participants
|
79.2 years
STANDARD_DEVIATION 4.36 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 7.73 • n=5 Participants
|
72.54 years
STANDARD_DEVIATION 4.18 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 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
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Outcome measure data not collected from participants in the Community Stakeholder Interviewees group
Daily steps are recorded on a continuously worn actigraphy watch (Withings), which measures 24-hour activity (gross motor activity).
Outcome measures
| Measure |
Cognitively Healthy Walkers
n=4 Participants
Participants were Black/African American adults aged 65 or over who have healthy cognition. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
Walking conversational reminiscence: Triadic walking with prompted conversational reminiscence
|
Mildly Cognitively Impaired (MCI) Walkers
n=5 Participants
Participants were Black/African American adults aged 65 or over who are mildly cognitively impaired. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
|
Community Stakeholder Interviewees
Participants were Black/African American adults aged 55 and over who were individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area
|
|---|---|---|---|
|
Daily Average Steps Recorded by Actigraphy Watch
|
2570 daily step count
Standard Deviation 1000
|
1140 daily step count
Standard Deviation 1030
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Outcome measure data not collected from participants in the Community Stakeholder Interviewees group
Emfit QS under-the-mattress sleep sensor measured sleep-wake cycles per 24-hour period.
Outcome measures
| Measure |
Cognitively Healthy Walkers
n=4 Participants
Participants were Black/African American adults aged 65 or over who have healthy cognition. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
Walking conversational reminiscence: Triadic walking with prompted conversational reminiscence
|
Mildly Cognitively Impaired (MCI) Walkers
n=5 Participants
Participants were Black/African American adults aged 65 or over who are mildly cognitively impaired. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
|
Community Stakeholder Interviewees
Participants were Black/African American adults aged 55 and over who were individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area
|
|---|---|---|---|
|
Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor
|
6.71 hours of sleep per night
Standard Deviation 1.75
|
5.07 hours of sleep per night
Standard Deviation 1.84
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Outcome measure data not collected from participants in the Community Stakeholder Interview group
Participants completed a brief health update survey every week via their home computer or phone. Response time (the time it took each participant to complete the survey) was recorded in seconds.
Outcome measures
| Measure |
Cognitively Healthy Walkers
n=4 Participants
Participants were Black/African American adults aged 65 or over who have healthy cognition. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
Walking conversational reminiscence: Triadic walking with prompted conversational reminiscence
|
Mildly Cognitively Impaired (MCI) Walkers
n=5 Participants
Participants were Black/African American adults aged 65 or over who are mildly cognitively impaired. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
|
Community Stakeholder Interviewees
Participants were Black/African American adults aged 55 and over who were individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area
|
|---|---|---|---|
|
Weekly Health Update Survey Response Time
|
195 seconds to complete weekly survey
Standard Deviation 33.2
|
472 seconds to complete weekly survey
Standard Deviation 234
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Outcome measure data not collected from participants in the Community stakeholder interviewees group
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire assessing sleep quality and sleep disturbances over a 1-month time period. The PQSI is composed of 19 query items, a combination of open-ended questions and Likert-type scales which are scored from 0 (no difficulty) to 3 (severe difficulty), and includes 7 sleep components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global score is calculated from the sum of scores for each of the seven components. Total scores range from 0 to 21, a higher score indicates more acute sleep disturbances.
Outcome measures
| Measure |
Cognitively Healthy Walkers
n=4 Participants
Participants were Black/African American adults aged 65 or over who have healthy cognition. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
Walking conversational reminiscence: Triadic walking with prompted conversational reminiscence
|
Mildly Cognitively Impaired (MCI) Walkers
n=5 Participants
Participants were Black/African American adults aged 65 or over who are mildly cognitively impaired. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
|
Community Stakeholder Interviewees
Participants were Black/African American adults aged 55 and over who were individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area
|
|---|---|---|---|
|
Pittsburgh Sleep Quality Index
|
7.00 score on a scale
Standard Deviation 4.55
|
5.60 score on a scale
Standard Deviation 3.65
|
—
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Outcome measure data not collected from participants in the Community Stakeholder Interviewees group
Healthy and mildly cognitively impaired participants completed a weekly online health update survey, receiving weekly reminders to complete it. Survey completion rates and completion times over the study's duration is another measure of cognitive change.
Outcome measures
| Measure |
Cognitively Healthy Walkers
n=67 surveys
Participants were Black/African American adults aged 65 or over who have healthy cognition. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
Walking conversational reminiscence: Triadic walking with prompted conversational reminiscence
|
Mildly Cognitively Impaired (MCI) Walkers
n=58 surveys
Participants were Black/African American adults aged 65 or over who are mildly cognitively impaired. Participants continuously wore an ActiGraph watch to assess activity level. Daily sleep behavior was captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data was collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continued to wear the actigraph watch and continued to sleep on the sleep sensor, and walked 4-16 weeks with their triads. Triads walked 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) were accessed via the SHARP Walking Application via a group Android tablet device.
|
Community Stakeholder Interviewees
Participants were Black/African American adults aged 55 and over who were individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area
|
|---|---|---|---|
|
Weekly Survey Completion Rate
|
91 percentage of survey completion
|
60 percentage of survey completion
|
—
|
Adverse Events
Cognitively Healthy Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mildly Cognitively Impaired (MCI) Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community Stakeholder Interviewees
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
Raina Croff, PhD Study investigator/ KL2 trainee
Oregon Heatlh & Science University
Phone: 503-494-2367
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place