Efficacy of a Multimodal Brain Health Intervention for Older African Americans

NCT04863378 | Completed Results

• 2 other identifiers: STUDY00022363KL2TR002370
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment, Mild; Cognitive Decline

Keywords

social engagement; neighborhood walking; reminiscence; physical activity; African American; Mild cognitive impairment

Outcome Measures

Primary Outcomes (5)

• Daily Average Steps Recorded by Actigraphy Watch

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

  24 weeks

• Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor

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

  24 weeks

• Weekly Health Update Survey Response Time

  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.

  24 weeks

• Pittsburgh Sleep Quality Index

  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.

  24 weeks

• Weekly Survey Completion Rate

  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.

  24 Weeks

Study Arms (3)

Cognitive healthy participants

EXPERIMENTAL

Participants are Black/African American adults aged 65 or over who are cognitively healthy according to a baseline Montreal Cognitive Assessment score of 24 or higher. Participants continuously wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data is collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continue to wear the actigraph watch and continued to sleep on the sleep sensor, and walk 4-16 weeks with their triads. Triads walk 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) are accessed via the SHARP Walking Application via a group Android tablet device.

Behavioral: Walking conversational reminiscence

Community stakeholder interviewees

NO INTERVENTION

Participants are Black/African American adults aged 55 and over who are individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area; Participants in this non-interventional group do not participate in study activities other than a qualitative interview.

Mildly Cognitively Impaired (MCI) participants

EXPERIMENTAL

Participants are Black/African American adults aged 65 or over who are mildly cognitively impaired according to a baseline Montreal Cognitive Assessment score below 24. Participants continuously wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data is collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continue to wear the actigraph watch and continued to sleep on the sleep sensor, and walk 4-16 weeks with their triads. Triads walk 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) are accessed via the SHARP Walking Application via a group Android tablet device.

Behavioral: Walking conversational reminiscence

Interventions

Walking conversational reminiscence BEHAVIORAL

Triadic walking with prompted conversational reminiscence

Also known as: SHARP: Sharing History through Active Reminiscence and Photo-imagery

Cognitive healthy participants; Mildly Cognitively Impaired (MCI) participants

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 29961887 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Raina Croff, PhD Study investigator/ KL2 trainee
• Organization: Oregon Heatlh & Science University

croff@ohsu.edu

503-494-2367

Study Officials

• Raina Croff, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 28, 2021
• Study Start: February 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: October 1, 2023
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)