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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05906667
Other study ID # 00016980
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date May 24, 2017
Est. completion date August 30, 2020

Study information

Verified date May 2023
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date August 30, 2020
Est. primary completion date April 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 95 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Carder, P., Croff, R., Tuttle, A., Towns, J. (2022) Walking and Talking: Recommendations for Doing Mobile Interviews with Older Adults. Journal of Aging and Environment, DOI: 10.1080/26892618.2022.2030844

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive function Pre/post Montreal Cognitive Assessment 24 weeks
Secondary Blood pressure pre/post blood pressure reading 24 weeks
Secondary Weight pre/post weight measurement 24 weeks
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