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ThumpThump Pilot Study

ThumpThump Pilot Study: Partnering With Communities to Improve Brain and Heart Care

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This pilot study tests a community program to help people check and manage high blood pressure. It is for 150 adults age 40 or older who live in Derby, Connecticut, whether or not they have high blood pressure. Everyone will get a home blood pressure cuff, and the study will help show whether a larger trial is possible.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Live in Derby, Connecticut.
  • Be age 40 or older.
  • Be able to agree to join after learning about the study, or have a legally authorized person agree for you.
  • Speak English or Spanish.

Who can't join

  • Definitely plan to move out of Derby in the next 6 months.
  • Are pregnant or plan to become pregnant in the next 6 months.
  • Are in another clinical trial that does not allow taking part in PROSPER at the same time.
  • Have a condition that the study doctor believes makes joining unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

CT