Cognitive Decline, Cognitive Impairment, Mild
Conditions
Keywords
social engagement, neighborhood walking, reminiscence, physical activity, African American, Mild cognitive impairment
Brief summary
This study tests the feasibility, acceptability, and efficacy of a multimodal intervention (walking, social engagement, and reminiscence), including the use of wearable digital biomarkers, for cognitively healthy and mildly cognitively impaired African Americans aged 65 and older.
Detailed description
Cognitively healthy and mildly cognitively impaired participants engage in up to 8 weeks of baseline data collection and 4-16 weeks of triadic neighborhood walking using a group tablet device to access pre-programmed 1-mile routes. GPS (Global Positioning System)-triggered historical images of local Black culture and history along the route prompt conversational reminiscence about Portland, Oregon's historically Black neighborhoods. Digital biomarker technology (a continuously worn actigraph watch and an unobtrusive under-the-mattress sleep sensor) and weekly online surveys via a study Chromebook assess feasibility, acceptability, efficacy, and health outcomes. Intermittent discussions and check-ins with participants, and observational sessions will be used to elicit participant feedback.
Interventions
BEHAVIORALWalking conversational reminiscence
Triadic walking with prompted conversational reminiscence
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Oregon Clinical and Translational Research Institute
University of California, Davis
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
for walkers: 1. Self-identified African American, 2. Age \> 65 years old 3. Reside or resided for \>10 years in Portland's historically Black neighborhoods (to be familiar with Memory Markers about this area), 4. Able to ambulate independently. 5. Meeting Cognition Criteria 1. Participants with MCI (Mild Cognitive Impairment) will meet criteria consistent with the criteria outlined by the NIA-Alzheimer's Association workgroup 2. Participants without cognitive impairment will have a Montreal Cognitive Assessment (MoCA) score \> 24 (and not meet MCI criteria). Participants' cognitive function should allow them to get to and from walk locations independently or with minimal assistance. 6. Cognitive function allows independent (or minimally assisted) travel to and from walk locations 7. In-home reliable broadband internet (for weekly online surveys). 8. Ability to read, speak, and understand English
Exclusion criteria
1. Self-reported or clinically diagnosed dementia 2. Significant disease of the central nervous system 3. Severely depressed (CES-D score \> 16), significantly symptomatic psychiatric disorder 4. Advanced cardiovascular disease that would make walking difficult, including history of congestive heart failure 5. Unstable insulin-dependent diabetes mellitus, received diagnosis Type 1 Diabetes, started insulin within past 3 months, hospitalized for hypoglycemia within past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Average Steps Recorded by Actigraphy Watch | 24 weeks | Daily steps are recorded on a continuously worn actigraphy watch (Withings), which measures 24-hour activity (gross motor activity). |
| Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor | 24 weeks | Emfit QS under-the-mattress sleep sensor measured sleep-wake cycles per 24-hour period. |
| Weekly Health Update Survey Response Time | 24 weeks | 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. |
| Pittsburgh Sleep Quality Index | 24 weeks | 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. |
| Weekly Survey Completion Rate | 24 Weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 5 |
| Community Stakeholder Interviewees 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 | 4 |
| Total | 13 |
Baseline characteristics
| Characteristic | Mildly Cognitively Impaired (MCI) Participants | Community Stakeholder Interviewees | Total | Cognitively Healthy Participants |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 11 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Age, Continuous | 79.2 years STANDARD_DEVIATION 4.36 | 66.5 years STANDARD_DEVIATION 7.73 | 72.54 years STANDARD_DEVIATION 4.18 | 71.1 years STANDARD_DEVIATION 4.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 13 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 5 participants | 4 participants | 13 participants | 4 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 11 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 | 0 / 4 |
Outcome results
Primary
Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor
Emfit QS under-the-mattress sleep sensor measured sleep-wake cycles per 24-hour period.
Time frame: 24 weeks
Population: Outcome measure data not collected from participants in the Community Stakeholder Interviewees group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitively Healthy Walkers | Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor | 6.71 hours of sleep per night | Standard Deviation 1.75 |
| Mildly Cognitively Impaired (MCI) Walkers | Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor | 5.07 hours of sleep per night | Standard Deviation 1.84 |
Primary
Daily Average Steps Recorded by Actigraphy Watch
Daily steps are recorded on a continuously worn actigraphy watch (Withings), which measures 24-hour activity (gross motor activity).
Time frame: 24 weeks
Population: Outcome measure data not collected from participants in the Community Stakeholder Interviewees group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitively Healthy Walkers | Daily Average Steps Recorded by Actigraphy Watch | 2570 daily step count | Standard Deviation 1000 |
| Mildly Cognitively Impaired (MCI) Walkers | Daily Average Steps Recorded by Actigraphy Watch | 1140 daily step count | Standard Deviation 1030 |
Primary
Pittsburgh Sleep Quality Index
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.
Time frame: 24 weeks
Population: Outcome measure data not collected from participants in the Community stakeholder interviewees group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitively Healthy Walkers | Pittsburgh Sleep Quality Index | 7.00 score on a scale | Standard Deviation 4.55 |
| Mildly Cognitively Impaired (MCI) Walkers | Pittsburgh Sleep Quality Index | 5.60 score on a scale | Standard Deviation 3.65 |
Primary
Weekly Health Update Survey Response Time
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.
Time frame: 24 weeks
Population: Outcome measure data not collected from participants in the Community Stakeholder Interview group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitively Healthy Walkers | Weekly Health Update Survey Response Time | 195 seconds to complete weekly survey | Standard Deviation 33.2 |
| Mildly Cognitively Impaired (MCI) Walkers | Weekly Health Update Survey Response Time | 472 seconds to complete weekly survey | Standard Deviation 234 |
Primary
Weekly Survey Completion Rate
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.
Time frame: 24 Weeks
Population: Outcome measure data not collected from participants in the Community Stakeholder Interviewees group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cognitively Healthy Walkers | Weekly Survey Completion Rate | 91 percentage of survey completion |
| Mildly Cognitively Impaired (MCI) Walkers | Weekly Survey Completion Rate | 60 percentage of survey completion |