Clinical trial NCT04863378: Efficacy of a Multimodal Brain Health Intervention for Older African Americans
Official title: Efficacy of a Technology-Based Multimodal Brain Health Intervention for Older African Americans: The SHARP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment, Mild
Cognitive Decline
Keywords: social engagement
neighborhood walking
reminiscence
physical activity
African American
Mild cognitive impairment
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: Oregon Clinical and Translational Research Institute
name: University of California, Davis
First posted: 2021-04-28
Enrollment: 13
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria for walkers:

1. Self-identified African American,
2. Age \> 65 years old
3. Reside or resided for \>10 years in Portland's historically Black neighborhoods (to be familiar with Memory Markers about this area),
4. Able to ambulate independently.
5. Meeting Cognition Criteria

   1. Participants with MCI (Mild Cognitive Impairment) will meet criteria consistent with the criteria outlined by the NIA-Alzheimer's Association workgroup
   2. 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.
6. Cognitive function allows independent (or minimally assisted) travel to and from walk locations
7. In-home reliable broadband internet (for weekly online surveys).
8. Ability to read, speak, and understand English

Exclusion Criteria:

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

Primary outcomes:
measure: Daily Average Steps Recorded by Actigraphy Watch
timeFrame: 24 weeks
measure: Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor
timeFrame: 24 weeks
measure: Weekly Health Update Survey Response Time
timeFrame: 24 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 24 weeks
measure: Weekly Survey Completion Rate
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Raina Croff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.