- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05906667
Sharing History Through Active Reminiscence and Photo-imagery - With MCI (SHARP-MCI)
June 7, 2023 updated by: Oregon Health and Science University
Sharing History Through Active Reminiscence and Photo-imagery: A Neighborhood Approach to Increase Physical Activity and Social Engagement
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
All participants assigned to the experimental group (walking)
|
Participants engage in neighborhood walks and conversational reminisce three times per week over 24 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: 24 weeks
|
Pre/post Montreal Cognitive Assessment
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: 24 weeks
|
pre/post blood pressure reading
|
24 weeks
|
Weight
Time Frame: 24 weeks
|
pre/post weight measurement
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2017
Primary Completion (Actual)
April 30, 2018
Study Completion (Actual)
August 30, 2020
Study Registration Dates
First Submitted
June 7, 2023
First Submitted That Met QC Criteria
June 7, 2023
First Posted (Estimated)
June 16, 2023
Study Record Updates
Last Update Posted (Estimated)
June 16, 2023
Last Update Submitted That Met QC Criteria
June 7, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 00016980
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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