Efficacy of a Multimodal Brain Health Intervention for Older African Americans

Not Applicable

Completed

Conditions: Cognitive Decline
Cognitive Impairment, Mild

Interventions: Behavioral: Walking conversational reminiscence

Registration Number: NCT04863378

Lead Sponsor: Oregon Health and Science University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 13

Inclusion Criteria

Not provided

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Walkers	Walking conversational reminiscence	Walkers continuously wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. Participants walk 1-mile routes in triads, three times a week for 16 weeks while engaging in prompted conversational reminiscence recorded for a digital archive.

Primary Outcome Measures

Name	Time	Method
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.