Who Can Join

Screening Process

Enroll in the Study

Meet with a Pressure Check health advocates at one of our partnered CBOs to enroll in the study. After signing consent, you’ll receive a free blood pressure cuff and Stel device. We will teach you how to take your blood pressure at home and transmit the readings using the Stel device. You’ll take a survey asking questions about your physical, mental, and social well-being. And we’ll set you up with appointments based on one of the 3 care plans that we are comparing.

Your Blood Pressure Story

Whether you've just discovered you have high blood pressure or have been managing hypertension for a while, you are welcome to join the study if you meet the other criteria.

Blood Pressure Status

Specifically, we're looking for participants with an average resting blood pressure of 135/85 mmHg or higher. This will be determined by three consecutive blood pressure readings taken at the study site, with the last two readings used to calculate your average blood pressure.

Age

Adults aged 18 years or older

You might be ineligible if..

1 - You Are Expecting or Are Pregnant: Due to the specialized care required, pregnant individuals are not included.

2 - Advanced Kidney Disease: Those with end-stage renal disease on dialysis are also excluded.

3 - Cancer Treatment: Individuals currently receiving active chemotherapy are not eligible, as they require specialized medical care.

Enrollment Process

“Enrolling in the PRESSURE CHECK Study is straightforward and designed with your convenience in mind. Begin by getting your blood pressure screened at one of our community-based organization (CBO) partners. If your screening indicates that you have elevated blood pressure we’ll ask you a few more questions to confirm that you meet the study’s criteria. Once eligible, you’ll be guided through an informed consent process where all aspects of your participation are explained, and all your questions are addressed. With consent, you become a valuable member of the PRESSURE CHECK community, embarking on a journey of health monitoring and support. Our team will be with you at every step, ensuring a smooth and supportive experience as we work together towards better health outcomes.”

Participant Responsibilities

  • Measure your blood pressure twice daily: once in the morning before noon and once in the evening before midnight— using the provided BP cuff and Stel Hub

  • Please ensure that it is not used by anyone else to maintain the accuracy of your health records.

  • Attend your follow-up appointments at the Community-Based Organization (CBO) you enrolled with at 6, 12, and 18 months.

  • Stay in regular communication with the study team.

  • Keep the BP cuff- it’s yours, but return your Stel device to the CBO at 6 months

    • Meet with us every 2 weeks for the first 3 months

    • Then monthly for the 2nd 3 months.

    • After 6 months, you graduate! Congratulations.

    • Come back for your 6 month visit

FAQs

  • What is the research component? I will not be a “guinea pig.”

    The research component aims to identify the most effective method for managing blood pressure. It involves community-based screening, providing participants with home blood pressure cuffs, and testing three follow-up strategies: with your primary care provider, a specialized medical team focused on blood pressure, or a specialized team plus a community health worker. No experimental medications or treatments are used.

  • Can I withdraw from the study, and if so, how?

    Yes, you can withdraw from the study at any time without any penalty. To withdraw, you simply need to inform the study team.

  • Are there any restrictions on the use of the Automated Blood Pressure Monitoring device?

    Only the enrolled participant should use the blood pressure cuff for the first 6 months of the study. The device is for personal use only and is not to be shared.

  • How will the results of the study be shared with participants?

    Participants will receive a personal communication about the study results, including links to publications and press releases about the study.

  • Is the care I receive today in place of my primary care provider or other medical team?

    No, the care received in this program is in addition to the care you currently receive. We will help you manage your blood pressure for 6 months. You should continue going to your primary care provider and other doctors as you normally would. We will communicate with your PCP so they are aware of the care you received through Pressure Check.

  • How and when will compensation be distributed?

    Gift cards will be handed out after completing study visits by the research staff, you will receive a receipt and instructions on how to activate your card.

  • What measures are in place to protect my privacy?

    Your contact information is stored securely at study sites and is used only for study-related communication. All study data are anonymized with a unique identification number for each participant, ensuring your personal identity remains private. After the study concludes, all records are maintained securely for the duration required by the Institutional Review Board (IRB) and other regulatory guidelines.When the study is completed, all databases are de-identified, which means any information that could be used to identify you is removed, ensuring your anonymity in any subsequent data analyses or reports.

  • What is the purpose of this RBPM / Remote Blood Pressure Monitoring Arm of the study?

    The purpose is to evaluate the effectiveness of monitoring and managing high blood pressure using a combination of home blood pressure monitoring and telehealth visits.

  • How much time will I need to dedicate to the study?

    You will need to check your blood pressure at home tadd that checking BP twice a day, at least 3 times per week. These appointments will be every other week for the first 3 months, then monthly for the second 3 months. After 6 months we will graduate you from the program. We will communicate with your PCP at the start and end of the 6-month period, updating them about any changes to your medications or care plan that occurred during the study. Overall, you should expect to spend a small amount of time each day.

  • Is there any compensation for participating?

    Participants will be compensated $50 for the enrollment visit. You will additionally receive $75 after completing the 6 month visit BP readings, survey, and return of the Stel device (you keep the BP cuff). You will additionally receive $25 after completing the 12 month visit and another $25 for completing the 18 month visit.

  • How and to whom should I report any adverse events or safety concerns?

    Adverse events like new healthcare issues can be sent to the contact page on the website and a study staff member will get in contact with you within 2 business days. To streamline a response, please complete the contact form of the site you enrolled at.

  • Are there any risks associated with participating in the study?

    There are minimal risks involved in this study. The primary risk is related to the inconvenience of daily blood pressure monitoring and the possibility of experiencing anxiety or stress if your readings are high. However, these risks are generally low, and the study team will guide you on how to manage any concerns.

Study Timeline

Embark on a journey of health discovery, our study is a multi-year effort to improve blood pressure management, and here’s how our timeline unfolds!

  • Study Launch: We officially began our quest in September 2023.

  • Enrollment Opens: March 2024 marks the start of participant enrollment — your opportunity to join us begins here.

  • Years of Discovery: Our study is divided into yearly segments, each with specific goals:

    Year 1: We kick off with pre-implementation and initial recruitment efforts.

    Year 2-5: We continue to recruit participants while rolling out our interventions.

    Follow-Up: After the intervention phase, we will have follow-up periods to monitor and evaluate the long-term impacts of our study.

  • Closing the Chapter: By July 2028, we aim to complete the study, with follow-up concluding in August 2027. This is when we will analyze the data and share our findings with the world.

Your participation could make a significant impact on not only your health but also on future healthcare practices. Keep an eye on our progress bar and milestones — join us and be a part of this crucial research!

Progress Tracker

(As of June 3, 2024)