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SHARP-MCI: Sharing History Through Active Reminiscence and Photo-imagery - With MCI

Sponsor
Oregon Health and Science University (Other)
Overall Status
Completed
CT.gov ID
NCT05906667
Collaborator
(none)
23
Enrollment
1
Location
1
Arm
39.2
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The SHARP-MCI study tests impact of walking and social reminiscence on cognitive function, blood pressure, and weight among healthy Black Americans and those experiencing mild cognitive impairment (MCI).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sharing History through Active Reminiscence and Photo-imagery (SHARP)
 Early Phase 1

Detailed Description

For 6 months (24 weeks), triads of healthy and MCI Black adults aged 55 and over walk 3x/week (1 mile) in Portland's historically Black neighborhoods. Triads follow GPS-mapped routes accessible via the SHARP walking application on a group tablet device. At three points along each route, GPS-triggered "Memory Markers" (historical images of local Black culture and life from1940-2010) appear on the tablet screen serving as a conversational reminisce prompt as the triad walks. At baseline and 24 weeks, cognitive function is measured via the Montreal Cognitive Assessment (MoCA), and weight and blood pressure are measured. Pre-post health surveys rate activity levels, days feeling downhearted/blue, energy level, and health status. Program evaluation surveys at month 1, 3, 6 assess mood, pace and dose of walking, prompt effectiveness, program readiness, and liklihood to recommend program to others. Focus groups at month 1, 3, 6 evaluate participants' program experience and needed changes.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single-arm study; all participants are assigned to the experimentsingle-arm study; all participants are assigned to the experiment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Sharing History Through Active Reminiscence and Photo-imagery: A Neighborhood Approach to Increase Physical Activity and Social Engagement
Actual Study Start Date :
May 24, 2017
Actual Primary Completion Date :
Apr 30, 2018
Actual Study Completion Date :
Aug 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

All participants assigned to the experimental group (walking)

Behavioral: Sharing History through Active Reminiscence and Photo-imagery (SHARP)
Participants engage in neighborhood walks and conversational reminisce three times per week over 24 weeks
Other Names:
  • SHARP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive function [24 weeks]

      Pre/post Montreal Cognitive Assessment

    Secondary Outcome Measures

    1. Blood pressure [24 weeks]

      pre/post blood pressure reading

    2. Weight [24 weeks]

      pre/post weight measurement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Self-identified African American

    • 55 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. Participants (n=7) with MCI will meet criteria consistent with those defined by Jak et al. 2009 and with criteria outlined by the NIA-Alzheimer's Association workgroup (2011)

    • Participants without cognitive impairment (n=14) will have an MMSE score > 24 (and not meet MCI criteria).

    • Participants' cognitive function should allow them to get to/ from walk locations independently or with minimal assistance

    Exclusion Criteria:

    • Serious or unstable medical condition (such as, but not limited to, cardiovascular disease, pulmonary disease, or severe arthritis) where participation in the trial would, in the opinion of the investigator, pose a significant health risk to the subject.

    • Diagnosis of Alzheimer's disease, vascular dementia, Parkinson's disease, or other dementing illness.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT05906667
    Other Study ID Numbers:
    • 00016980
    First Posted:
    Jun 18, 2023
    Last Update Posted:
    Jun 18, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 18, 2023