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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002370 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| Oregon Clinical and Translational Research Institute | OTHER |
| University of California, Davis | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive healthy participants | Experimental | Participants are 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 wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data is collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continue to wear the actigraph watch and continued to sleep on the sleep sensor, and walk 4-16 weeks with their triads. Triads walk 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) are accessed via the SHARP Walking Application via a group Android tablet device. |
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| Community stakeholder interviewees | No Intervention | Participants are Black/African American adults aged 55 and over who are individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area; Participants in this non-interventional group do not participate in study activities other than a qualitative interview. | |
| Mildly Cognitively Impaired (MCI) participants | Experimental | Participants are 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 wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data is collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continue to wear the actigraph watch and continued to sleep on the sleep sensor, and walk 4-16 weeks with their triads. Triads walk 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) are accessed via the SHARP Walking Application via a group Android tablet device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking conversational reminiscence | Behavioral | Triadic walking with prompted conversational reminiscence |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 weeks |
| 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. | 24 weeks |
| 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. | 24 weeks |
| 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. | 24 weeks |
| 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. | 24 Weeks |
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Inclusion Criteria for walkers:
Self-identified African American,
Age > 65 years old
Reside or resided for >10 years in Portland's historically Black neighborhoods (to be familiar with Memory Markers about this area),
Able to ambulate independently.
Meeting Cognition Criteria
Cognitive function allows independent (or minimally assisted) travel to and from walk locations
In-home reliable broadband internet (for weekly online surveys).
Ability to read, speak, and understand English
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raina Croff, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29961887 | Background | Croff RL, Witter Iv P, Walker ML, Francois E, Quinn C, Riley TC, Sharma NF, Kaye JA. Things Are Changing so Fast: Integrative Technology for Preserving Cognitive Health and Community History. Gerontologist. 2019 Jan 9;59(1):147-157. doi: 10.1093/geront/gny069. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Outcome measure data not collected from participants in the Community Stakeholder Interviewees group | Posted | Mean | Standard Deviation | daily step count | 24 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitively Healthy Participants | Participants were Black/African Americans aged 65 and over who are cognitively healthy according to a baseline Montreal Cognitive Assessment score of 24 or higher. Walkers continuously wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. After up to 8 weeks of baseline data collection, participants walked 1-mile routes in triads, three times a week for 4-16 weeks while engaging in prompted conversational reminiscence recorded for a digital archive. Walking conversational reminiscence: Triadic walking with prompted conversational reminiscence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raina Croff, PhD Study investigator/ KL2 trainee | Oregon Heatlh & Science University | 503-494-2367 | croff@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 17, 2024 | Jul 16, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| BG001 | 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. |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Mildly Cognitively Impaired (MCI) Walkers | 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. |
| OG002 | 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 |
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| 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. | Outcome measure data not collected from participants in the Community Stakeholder Interviewees group | Posted | Mean | Standard Deviation | hours of sleep per night | 24 weeks |
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|
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| 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. | Outcome measure data not collected from participants in the Community Stakeholder Interview group | Posted | Mean | Standard Deviation | seconds to complete weekly survey | 24 weeks |
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| 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. | Outcome measure data not collected from participants in the Community stakeholder interviewees group | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
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| 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. | Outcome measure data not collected from participants in the Community Stakeholder Interviewees group | Posted | Number | percentage of survey completion | 24 Weeks | surveys | surveys |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Mildly Cognitively Impaired (MCI) Participants | Participants were Black/African Americans aged 65 and over who are mildly cognitively impaired according to a baseline Montreal Cognitive Assessment score below 24. Walkers continuously wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. After up to 8 weeks of baseline data collection, participants walked 1-mile routes in triads, three times a week for 4-16 weeks while engaging in prompted conversational reminiscence recorded for a digital archive. Walking conversational reminiscence: Triadic walking with prompted conversational reminiscence | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | 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 | 0 | 4 | 0 | 4 | 0 | 4 |
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