Cognitive ChangeEarly Phase 1SHARP-MCINCT05906667
Sharing History Through Active Reminiscence and Photo-imagery - With MCI
A Early Phase 1 study testing Sharing History through Active Reminiscence and Photo-imagery (SHARP) in people with Cognitive Change, run by Oregon Health and Science University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 55 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Sharing History through Active Reminiscence and Photo-imagery (SHARP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2017to 30 Aug 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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).
Read the 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.
- Conditions
- Cognitive Change
- Being tested
- Sharing History through Active Reminiscence and Photo-imagery (SHARP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sharing History through Active Reminiscence and Photo-imagery (SHARP)Behavioural
Also called SHARP
Participants engage in neighborhood walks and conversational reminisce three times per week over 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | All participants assigned to the experimental group (walking) Receives: Behavioral: Sharing History through Active Reminiscence and Photo-imagery (SHARP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Pre/post Montreal Cognitive Assessment
Measured: 24 weeks
Secondary outcomes (2)
Blood pressure
pre/post blood pressure reading
Measured: 24 weeks
Weight
pre/post weight measurement
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start24 May 2017
- Primary completion30 Apr 2018
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm study; all participants are assigned to the experiment
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906667
- Sponsor's protocol ID
- 00016980
- Acronym
- SHARP-MCI
- Status last verified
- May 2023
- First submitted
- 7 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
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.
PubMed 38412543
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sharing History Through Active Reminiscence and Photo-imagery: A Neighborhood Approach to Increase Physical Activity and Social Engagement
- ClinicalTrials.gov ID
- NCT05906667
- Acronym / sponsor ID
- SHARP-MCI / 00016980
- Conditions
- Cognitive Change
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm study; all participants are assigned to the experiment
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Sharing History through Active Reminiscence and Photo-imagery (SHARP)All participants assigned to the experimental group (walking) |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sharing History through Active Reminiscence and Photo-imagery (SHARP)Also: SHARPParticipants engage in neighborhood walks and conversational reminisce three times per week over 24 weeks | Behavioural | Intervention Group |
Primary outcome
Cognitive function
Time frame: 24 weeks
Pre/post Montreal Cognitive Assessment
2 secondary outcomes
Blood pressure
Time frame: 24 weeks
Weight
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- BackgroundCarder, 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
- Derived from this study: PubMed 38412543Croff 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sharing History through Active Reminiscence and Photo-imagery (SHARP) in people with Cognitive Change, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05906667, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.