N/A
Completed N=13
Efficacy of a Multimodal Brain Health Intervention for Older African Americans
Cognitive Impairment, Mild · Cognitive Decline
Source: ClinicalTrials.gov NCT04863378 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Daily Average Steps Recorded by Actigraphy Watch — 2570; 1140 daily step count
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Average Steps Recorded by Actigraphy Watch |
2570; 1140 | — |
| PRIMARY Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor |
6.71; 5.07 | — |
| PRIMARY Weekly Health Update Survey Response Time |
195; 472 | — |
| PRIMARY Pittsburgh Sleep Quality Index |
7.00; 5.60 | — |
| PRIMARY Weekly Survey Completion Rate |
91; 60 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04863378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.