N/A
N=13
Efficacy of a Multimodal Brain Health Intervention for Older African Americans
Cognitive Impairment, Mild · Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT04863378 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Daily Average Steps Recorded by Actigraphy Watch — 2570; 1140 daily step count
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Walking conversational reminiscence (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jun 2023
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 | — |
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.
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.