NCT05906667

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

June 7, 2023

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Pre/post Montreal Cognitive Assessment

    24 weeks

Secondary Outcomes (2)

  • Blood pressure

    24 weeks

  • Weight

    24 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

All participants assigned to the experimental group (walking)

Behavioral: Sharing History through Active Reminiscence and Photo-imagery (SHARP)

Interventions

Participants engage in neighborhood walks and conversational reminisce three times per week over 24 weeks

Also known as: SHARP
Intervention Group

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • 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

    BACKGROUND
  • Croff R, Aron S, Wachana A, Fuller P, Mattek N, Towns J, Kaye J. Walking and Social Reminiscence in Gentrifying Neighborhoods: Feasibility and Impact on Cognitive, Physical, and Mental Health Among Older Black Adults in the SHARP Study. Gerontologist. 2024 Sep 1;64(9):gnae019. doi: 10.1093/geront/gnae019.

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: single-arm study; all participants are assigned to the experiment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 18, 2023

Study Start

May 24, 2017

Primary Completion

April 30, 2018

Study Completion

August 30, 2020

Last Updated

June 18, 2023

Record last verified: 2023-05

Locations