Cognitive ChangeEarly Phase 1SHARPNCT05906654
Sharing History Through Active Reminiscence and Photo-imagery (SHARP) Pilot Program
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.
Trial summary
SHARP is a neighborhood-based and technology-supported approach to brain health for older Black adults that integrates walking and image-prompted social reminiscence to maintain or improve brain health. Read more about this study
- Who is it for?
- Ages 55 to 99 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
- 21 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2016to 30 Jul 2018
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified African American
- > 55 years old
- A long-time resident (>10 cumulative years) of Portland's historically black neighborhoods (currently or in within the last 10 years)
- Without symptoms of and without a diagnosis of Alzheimer's Disease (they must be preclinical subjects),
- Without serious cognitive impairment and must score > 24 on the age-education adjusted Mini-Mental State Exam
- Has internet access in the home.
- Able to ambulate independently, without walking aids
- Able to sustain walking at a moderate pace for 45 minutes.
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.
About this study
Official title: Oregon Healthy Brain Research Network Collaborative Center (OrHBRN): Sharing History Through Active Reminiscence and Photo-imagery (SHARP) Pilot Program
SHARP is a neighborhood-based and technology-supported approach to brain health for older Black adults that integrates walking and image-prompted social reminiscence to maintain or improve brain health.
Read the detailed description
The SHARP study tests the feasibility, usability, and cultural relevance of an android application-supported walking study for brain health among older Black adults. The SHARP walking application enables the seamless integration of the brain-healthy behaviors of walking, social engagement, and reminiscence. Methods: Over the course of 24 weeks in the rapidly gentrifying historically Black neighborhoods of Portland, Oregon, triads aim to complete three 1-mile walks per week. The SHARP application is preprogrammed with 72 themed, 1-mile routes, accessible via a group tablet device. At three points along each route, GPS-triggered "Memory Markers" (historical images of local Black culture) appear on the walking application, serving as prompts for conversational reminiscence as triads walk. Walking reminiscence sessions are recorded for inclusion into a digital oral history archive.
- 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
Behavioral intervention to increase physical and social activity. In triads, participants walk 1-mile neighborhood routes three times per week and engage in image-based conversational reminiscence.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants engage in walking and conversational reminiscence three times per week 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.
Feasibility
Program readiness scale - how close is the program to being ready to deploy to other older Black Americans?
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 start5 Feb 2016
- Primary completion25 Apr 2017
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 21 individuals without cognitive impairment engage in the study intervention over 24 weeks
- Enrolment
- 21 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
- NCT05906654
- Sponsor's protocol ID
- 00011936
- Acronym
- SHARP
- 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
- No
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 RL, Witter Iv P, Walker ML, Francois E, Quinn C, Riley TC, Sharma NF, Kaye JA. Things Are Changing so Fast: Integrative Technology for Preserving Cognitive Health and Community History. Gerontologist. 2019 Jan 9;59(1):147-157. doi: 10.1093/geront/gny069.
PubMed 29961887Croff 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
- Oregon Healthy Brain Research Network Collaborative Center (OrHBRN): Sharing History Through Active Reminiscence and Photo-imagery (SHARP) Pilot Program
- ClinicalTrials.gov ID
- NCT05906654
- Acronym / sponsor ID
- SHARP / 00011936
- Conditions
- Cognitive Change
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 5 Feb 2016 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 30 Jul 2018 (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.
SHARP is a neighborhood-based and technology-supported approach to brain health for older Black adults that integrates walking and image-prompted social reminiscence to maintain or improve brain health.
Detailed description
The SHARP study tests the feasibility, usability, and cultural relevance of an android application-supported walking study for brain health among older Black adults. The SHARP walking application enables the seamless integration of the brain-healthy behaviors of walking, social engagement, and reminiscence. Methods: Over the course of 24 weeks in the rapidly gentrifying historically Black neighborhoods of Portland, Oregon, triads aim to complete three 1-mile walks per week. The SHARP application is preprogrammed with 72 themed, 1-mile routes, accessible via a group tablet device. At three points along each route, GPS-triggered "Memory Markers" (historical images of local Black culture) appear on the walking application, serving as prompts for conversational reminiscence as triads walk. Walking reminiscence sessions are recorded for inclusion into a digital oral history archive.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
- Model description
- 21 individuals without cognitive impairment engage in the study intervention over 24 weeks
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Sharing History through Active Reminiscence and Photo-imagery (SHARP)Participants engage in walking and conversational reminiscence three times per week |
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-identified African American
- > 55 years old
- A long-time resident (>10 cumulative years) of Portland's historically black neighborhoods (currently or in within the last 10 years)
- Without symptoms of and without a diagnosis of Alzheimer's Disease (they must be preclinical subjects),
- Without serious cognitive impairment and must score > 24 on the age-education adjusted Mini-Mental State Exam
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: SHARPBehavioral intervention to increase physical and social activity. In triads, participants walk 1-mile neighborhood routes three times per week and engage in image-based conversational reminiscence. | Behavioural | Intervention Group |
Primary outcome
Feasibility
Time frame: 24 weeks
Program readiness scale - how close is the program to being ready to deploy to other older Black Americans?
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
- Results publication: PubMed 29961887Croff RL, Witter Iv P, Walker ML, Francois E, Quinn C, Riley TC, Sharma NF, Kaye JA. Things Are Changing so Fast: Integrative Technology for Preserving Cognitive Health and Community History. Gerontologist. 2019 Jan 9;59(1):147-157. doi: 10.1093/geront/gny069.
- 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: No
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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.
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.
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 8 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.
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?
Feasibility (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 NCT05906654, which also lists 3 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.