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Completed

NCT Number: NCT04863378

Efficacy of a Multimodal Brain Health Intervention for Older African Americans

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.

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Key information

Conditions

Cognitive Impairment, Mild Behavior Cognition Disorders Cognitive Decline Cognitive Dysfunction Mental Disorders Motor Activity Neurocognitive Disorders

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Participants with MCI (Mild Cognitive Impairment) will meet criteria consistent with the criteria outlined by the NIA-Alzheimer's Association workgroup
  • 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.
  • 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

  • Self-reported or clinically diagnosed dementia
  • Significant disease of the central nervous system
  • Severely depressed (CES-D score > 16), significantly symptomatic psychiatric disorder
  • Advanced cardiovascular disease that would make walking difficult, including history of congestive heart failure
  • Unstable insulin-dependent diabetes mellitus, received diagnosis Type 1 Diabetes, started insulin within past 3 months, hospitalized for hypoglycemia within past 6 months.

Treatment and study plan

Walking conversational reminiscence

Behavioral

Triadic walking with prompted conversational reminiscence

Other names: SHARP: Sharing History through Active Reminiscence and Photo-imagery

Primary outcomes

  1. Daily Average Steps Recorded by Actigraphy Watch

    Time frame: 24 weeks

    Daily steps are recorded on a continuously worn actigraphy watch (Withings), which measures 24-hour activity (gross motor activity).

  2. Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor

    Time frame: 24 weeks

    Emfit QS under-the-mattress sleep sensor measured sleep-wake cycles per 24-hour period.

  3. Weekly Health Update Survey Response Time

    Time frame: 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.

  4. Pittsburgh Sleep Quality Index

    Time frame: 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.

  5. Weekly Survey Completion Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • Oregon Clinical and Translational Research Institute
  • University of California, Davis

Registry information

Official study title

Efficacy of a Technology-Based Multimodal Brain Health Intervention for Older African Americans: The SHARP Study

Acronym: SHARP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2021
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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