Cognitive ImpairmentNCT06914947
Brain Health Together: Development and Pilot Test
An observational study of Cognitive Impairment and Subjective Cognitive Decline, run by University of California, San Francisco at 1 site in United States.
Trial summary
The objectives of this study were to develop and pilot-test Brain Health Together (BHT), a 12-week, virtual-group program that combines our evidence-based, mind-body, group movement program with brain health education and coaching to reduce dementia risk through targeting modifiable risk factors among older adults… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Subjective Cognitive Decline, Mild Cognitive Impairment (MCI)
- What is being tested?
- Brain Health Together
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 11 Oct 2022
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Our study population included people who were active participants in the Moving Together program as well as a purposeful sample of individuals who were not familiar with the Moving Together program. Together these individuals' perceptions would facilitate further examination and identification of challenges in understanding and managing MCI. Pilot Inclusion Criteria: * Mild cognitive impairment or subjective cognitive decline * English language proficiency * Active participants in Moving Together (Intervention Arm) Pilot Exclusion Criteria: * wheelchair user; medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually delivered multicomponent intervention * moderate/severe dementia severity
Who may be able to join
- Mild cognitive impairment or subjective cognitive decline
- English language proficiency
- Active participants in Moving Together (Intervention Arm)
Who cannot join
- wheelchair user
- medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually-delivered multicomponent intervention
- moderate/severe dementia severity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Brain Health Together: Use of Human-centered Design to Develop and Pilot a Virtual Group Brain Health Program
The objectives of this study were to develop and pilot-test Brain Health Together (BHT), a 12-week, virtual-group program that combines our evidence-based, mind-body, group movement program with brain health education and coaching to reduce dementia risk through targeting modifiable risk factors among older adults with cognitive impairment.
Read the detailed description
Our study design for developing, pilot-testing, and refining the BHT program was conducted in 2 phases. In Phase 1, the investigators used a human-centered design approach to deeply understand and respond to the needs, challenges, and motivations of potential users when developing the BHT program. In Phase 2, the investigators performed a pilot study to refine BHT program content and assess acceptability and potential feasibility.
- Being tested
- Brain Health Together
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Health TogetherBehavioural
Each week, the program included a 1-hour group brain health education class, a 1-hour group Moving Together class, and a 30-minute individual brain health coaching session (total: 2.5 hours/week). Before the first session, participants were asked to complete a brief online survey about lifestyle behaviors and medical conditions related to dementia risk. The first 4 brain health education classes focused on general content to introduce and reinforce the concept that healthy lifestyle behaviors and management of chronic medical conditions can improve cognitive function, delay cognitive decline, and potentially prevent dementia. Another goal was to introduce participants to health coaching and to help participants each set specific, measurable, achievable, realistic, time-limited (SMART) goals to improve brain health. The remaining 8 weeks were adjusted to accommodate participant feedback in the early portion of the pilot study.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm Pilot | 12-week pilot study with data collection and analysis at the completion of the initial 4 weeks of the program and at the completion of 12 weeks. Receives: Behavioral: Brain Health Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
To examine feasibility, the investigators tracked participant attendance, calculated as the mean±standard deviation (SD) of sessions completed by each participant.
Measured: 12 weeks
Acceptability
The investigators asked participants how likely they are to recommend BHT to others on a scale from 0 (not at all likely) to 10 (extremely likely) and calculated a net promoter score as the percentage of promoters (scores of 9 or 10) minus the percentage of detractors (scores of 0 to 6).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2025
- Study start30 Sep 2021
- Primary completion6 Sep 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914947
- Sponsor's protocol ID
- R44AG074727-B
- Other IDs
- R44AG074727
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the small number of participants and the exploratory nature of this trial, participants could potentially be identifiable.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Health Together: Use of Human-centered Design to Develop and Pilot a Virtual Group Brain Health Program
- ClinicalTrials.gov ID
- NCT06914947
- Acronym / sponsor ID
- R44AG074727-B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 7 Apr 2025 (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 objectives of this study were to develop and pilot-test Brain Health Together (BHT), a 12-week, virtual-group program that combines our evidence-based, mind-body, group movement program with brain health education and coaching to reduce dementia risk through targeting modifiable risk factors among older adults with cognitive impairment.
Detailed description
Our study design for developing, pilot-testing, and refining the BHT program was conducted in 2 phases. In Phase 1, the investigators used a human-centered design approach to deeply understand and respond to the needs, challenges, and motivations of potential users when developing the BHT program. In Phase 2, the investigators performed a pilot study to refine BHT program content and assess acceptability and potential feasibility.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm Pilot | – | Behavioral: Brain Health Together12-week pilot study with data collection and analysis at the completion of the initial 4 weeks of the program and at the completion of 12 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Our study population included people who were active participants in the Moving Together program as well as a purposeful sample of individuals who were not familiar with the Moving Together program. Together these individuals' perceptions would facilitate further examination and identification of challenges in understanding and managing MCI. Pilot Inclusion Criteria: * Mild cognitive impairment or subjective cognitive decline * English language proficiency * Active participants in Moving Together (Intervention Arm) Pilot Exclusion Criteria: * wheelchair user; medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually delivered multicomponent intervention * moderate/severe dementia severity
Key inclusion criteria (3 listed)
- Mild cognitive impairment or subjective cognitive decline
- English language proficiency
- Active participants in Moving Together (Intervention Arm)
Key exclusion criteria (3 listed)
- wheelchair user
- medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually-delivered multicomponent intervention
- moderate/severe dementia severity
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 |
|---|---|---|
| Brain Health TogetherEach week, the program included a 1-hour group brain health education class, a 1-hour group Moving Together class, and a 30-minute individual brain health coaching session (total: 2.5 hours/week). Before the first session, participants were asked to complete a brief online survey about lifestyle behaviors and medical conditions related to dementia risk. The first 4 brain health education classes focused on general content to introduce and reinforce the concept that healthy lifestyle behaviors and management of chronic medical conditions can improve cognitive function, delay cognitive decline, and potentially prevent dementia. Another goal was to introduce participants to health coaching and to help participants each set specific, measurable, achievable, realistic, time-limited (SMART) goals to improve brain health. The remaining 8 weeks were adjusted to accommodate participant feedback in the early portion of the pilot study. | Behavioural | Single-arm Pilot |
Primary outcome
Intervention Feasibility
Time frame: 12 weeks
To examine feasibility, the investigators tracked participant attendance, calculated as the mean±standard deviation (SD) of sessions completed by each participant.
Acceptability
Time frame: 12 weeks
The investigators asked participants how likely they are to recommend BHT to others on a scale from 0 (not at all likely) to 10 (extremely likely) and calculated a net promoter score as the percentage of promoters (scores of 9 or 10) minus the percentage of detractors (scores of 0 to 6).
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 10 Apr 2025.
- Individual participant dataSharing planned: No. Given the small number of participants and the exploratory nature of this trial, participants could potentially be identifiable.
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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?
An observational study of Cognitive Impairment and Subjective Cognitive Decline, run by University of California, San Francisco 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 3 inclusion and 3 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 10 Apr 2025. 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.
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?
Intervention Feasibility (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2025.