Preventive MedicineThumpThumpNCT07865247
ThumpThump Pilot Study
A study testing : Implementation strategy to improve hypertension care in geopolitically defined communities in people with Preventive Medicine and Hypertension, run by Yale University at 1 site in United States.
Trial summary
Brain disease and heart disease are the leading causes of death and disability in the US; at least 60% of cases can be attributed to modifiable risk factors such as hypertension, dyslipidemia, and poor-quality diet. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preventive Medicine, Hypertension
- What is being tested?
- : Implementation strategy to improve hypertension care in geopolitically defined communities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,680 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resident of Derby, Connecticut
- Age ≥40 years
- Able to provide informed consent or has a LAR who could consent
- Ability to speak English or Spanish
Who cannot join
- Definite intent to move out of town in the next 6 months
- Pregnancy or intention to become pregnant in the next 6 months.
- Participation in another clinical trial that prohibits co-participation in PROSPER.
- Considered by the investigator to have a condition that precludes safe participation in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale University
Derby, Connecticut, 06418
Walter N. Kernan, M.D., 203-530-1756, walter.kernan@yale.edu
Catherin M. VISCOLI, Ph.D., 203-927-0443, catherine.viscoli@yale.edu
About this study
Official title: ThumpThump Pilot Study: Partnering With Communities to Improve Brain and Heart Care
Brain disease and heart disease are the leading causes of death and disability in the US; at least 60% of cases can be attributed to modifiable risk factors such as hypertension, dyslipidemia, and poor-quality diet. Our mission is to deliver high-quality preventive care to whole geopolitically defined communities, reaching every resident. ThumpThump is a novel implementation strategy that 1) uses sociology, marketing, and behavioral science to engage residents and 2) adapts population health methods from high-functioning health systems to geopolitically defined communities. ThumpThump is starting with hypertension in Derby, CT in collaboration with city residents and city leaders.
The ThumpThump Pilot Study will estimate the likelihood that a large, definitive trial of ThumpThump can succeed. The pilot study will enroll 150 residents who are at least 40 years of age. Specific aims are: 1) demonstrate ThumpThump can reach residents of Derby, 2) measure and achieve fidelity to standard hypertension care, and 3) measure success in applying our implementation strategy. The pilot is a one-arm trial.
Proven population health methods from high-functioning health systems will be used to first classify participants according to hypertension (none, controlled, uncontrolled) and then help those in need get to goal. Home blood pressure cuffs will be given to all participants. Participants with no or controlled hypertension will have blood pressure re-measured at three and six months. Participants with uncontrolled hypertension will be offered two options: 1) to continue care from their personal healthcare professional or 2) to receive hypertension care directly from our team. With either method, the study will continue to monitor their blood pressure regularly. If they continue to receive care from their personal professional, participants will be offered support in following that professional's plan and the study will communicate and coordinate with their professional as appropriate. If they chose our team, a treatment algorithm will be used to help them get to their BP goal. Community health workers will be employed for participant enrollment and follow-up care (e.g., health education, blood pressure monitoring, treatment implementation, and navigation within health systems). Team care will include working with local health care professionals and institutions to advance a mutual mission, not replace their function. If successful, funds for a definitive trial will be sought with the long-term goal of targeting more risk factors and expanding to more communities.
- Conditions
- Preventive Medicine, Hypertension
- Being tested
- : Implementation strategy to improve hypertension care in geopolitically defined communities
- Keywords
- Hypertension, Community care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
: Implementation strategy to improve hypertension care in geopolitically defined communitiesOther
The implementation strategy has two stages. The first stage uses methods to reach adult residents of Derby for blood pressure measurement and enrollment in the PROSPER Clinical Trial for hypertension care (i.e., marketing to change how residents regard hypertension and cardiovascular health, social contagion techniques based on social network science to draw residents to PROSPER and develop interest in cardiovascular health, and financial incentives). The second stage adapts implementation methods developed for high performing practices and health systems to improve delivery of evidence-based hypertension care in a different context, which is the community (e.g., task-shifting and team care, standardized and client centered care, and audit and feedback with rapid small cycles of change).
| Study group | Role | What they receive |
|---|---|---|
| Hypertension care | Other | Implementation strategy to improve hypertension care in geopolitically defined communities Receives: Other: : Implementation strategy to improve hypertension care in geopolitically defined communities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement of adult residents of Derby (reach)
Enrollment of 150 residents of the city of Derby
Measured: 3 months from start of study
Fidelity to evidence-based hypertension classification
Proportion of enrolled subjects who complete hypertension classification
Measured: 3 months from start of study
Fidelity to evidence-based hypertension treatment
Proportion of enrolled subjects with uncontrolled hypertension who receive guideline-directed hypertension treatment within 2 months of treatment initiation
Measured: 2 months from initiation of hypertension therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start14 Oct 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive MedicineStudies of the same condition, open and under way.
- More trials run by Yale 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PROSPER is a multi-stage implementation study with an implementation and effectiveness aims designed to improve the uptake of hypertension care in geopolitically defined communities.
- Masking
- None (open label)
- Enrolment
- 3,680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter N. Kernan, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865247
- Sponsor's protocol ID
- 2000037069
- Acronym
- ThumpThump
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThumpThump Pilot Study: Partnering With Communities to Improve Brain and Heart Care
- ClinicalTrials.gov ID
- NCT07865247
- Acronym / sponsor ID
- ThumpThump / 2000037069
- Conditions
- Preventive Medicine, Hypertension
- Keywords
- Hypertension, Community care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,680 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 8 Oct 2026 (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.
Brain disease and heart disease are the leading causes of death and disability in the US; at least 60% of cases can be attributed to modifiable risk factors such as hypertension, dyslipidemia, and poor-quality diet. Our mission is to deliver high-quality preventive care to whole geopolitically defined communities, reaching every resident. ThumpThump is a novel implementation strategy that 1) uses sociology, marketing, and behavioral science to engage residents and 2) adapts population health methods from high-functioning health systems to geopolitically defined communities. ThumpThump is starting with hypertension in Derby, CT in collaboration with city residents and city leaders.
The ThumpThump Pilot Study will estimate the likelihood that a large, definitive trial of ThumpThump can succeed. The pilot study will enroll 150 residents who are at least 40 years of age. Specific aims are: 1) demonstrate ThumpThump can reach residents of Derby, 2) measure and achieve fidelity to standard hypertension care, and 3) measure success in applying our implementation strategy. The pilot is a one-arm trial.
Proven population health methods from high-functioning health systems will be used to first classify participants according to hypertension (none, controlled, uncontrolled) and then help those in need get to goal. Home blood pressure cuffs will be given to all participants. Participants with no or controlled hypertension will have blood pressure re-measured at three and six months. Participants with uncontrolled hypertension will be offered two options: 1) to continue care from their personal healthcare professional or 2) to receive hypertension care directly from our team. With either method, the study will continue to monitor their blood pressure regularly. If they continue to receive care from their personal professional, participants will be offered support in following that professional's plan and the study will communicate and coordinate with their professional as appropriate. If they chose our team, a treatment algorithm will be used to help them get to their BP goal. Community health workers will be employed for participant enrollment and follow-up care (e.g., health education, blood pressure monitoring, treatment implementation, and navigation within health systems). Team care will include working with local health care professionals and institutions to advance a mutual mission, not replace their function. If successful, funds for a definitive trial will be sought with the long-term goal of targeting more risk factors and expanding to more communities.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PROSPER is a multi-stage implementation study with an implementation and effectiveness aims designed to improve the uptake of hypertension care in geopolitically defined communities.
| Arm | Type | Receives |
|---|---|---|
| Hypertension care | Other | Other: : Implementation strategy to improve hypertension care in geopolitically defined communitiesImplementation strategy to improve hypertension care in geopolitically defined communities |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resident of Derby, Connecticut
- Age ≥40 years
- Able to provide informed consent or has a LAR who could consent
- Ability to speak English or Spanish
Key exclusion criteria (4 listed)
- Definite intent to move out of town in the next 6 months
- Pregnancy or intention to become pregnant in the next 6 months.
- Participation in another clinical trial that prohibits co-participation in PROSPER.
- Considered by the investigator to have a condition that precludes safe participation in the trial
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 |
|---|---|---|
| : Implementation strategy to improve hypertension care in geopolitically defined communitiesThe implementation strategy has two stages. The first stage uses methods to reach adult residents of Derby for blood pressure measurement and enrollment in the PROSPER Clinical Trial for hypertension care (i.e., marketing to change how residents regard hypertension and cardiovascular health, social contagion techniques based on social network science to draw residents to PROSPER and develop interest in cardiovascular health, and financial incentives). The second stage adapts implementation methods developed for high performing practices and health systems to improve delivery of evidence-based hypertension care in a different context, which is the community (e.g., task-shifting and team care, standardized and client centered care, and audit and feedback with rapid small cycles of change). | Other | Hypertension care |
Primary outcome
Engagement of adult residents of Derby (reach)
Time frame: 3 months from start of study
Enrollment of 150 residents of the city of Derby
Fidelity to evidence-based hypertension classification
Time frame: 3 months from start of study
Proportion of enrolled subjects who complete hypertension classification
Fidelity to evidence-based hypertension treatment
Time frame: 2 months from initiation of hypertension therapy
Proportion of enrolled subjects with uncontrolled hypertension who receive guideline-directed hypertension treatment within 2 months of treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
Walter N. Kernan, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing : Implementation strategy to improve hypertension care in geopolitically defined communities in people with Preventive Medicine and Hypertension, run by Yale 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walter N. Kernan, M.D. (203-530-1756, walter.kernan@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement of adult residents of Derby (reach) (time frame: 3 months from start of study). The study lists 3 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 8 Oct 2026.