What is this research about?
Someone who has already had a stroke is at risk of having another. The best way to prevent another stroke is to control high blood pressure. However, 70-80 percent of stroke survivors have high blood pressure and urgently need more help controlling their blood pressure.
This study will compare two ways to control high blood pressure in the first six months after a stroke. The first way is to teach the patient to use a Bluetooth-enabled blood pressure cuff at home and to provide clinical care remotely. The second way is to measure the patient’s blood pressure frequently at a clinic and provide clinical care in person.
Who can this research help?
Stroke survivors and doctors can use the results from this study to decide on the best way to prevent another stroke. Stroke survivors who are at the highest risk of having uncontrolled blood pressure and another stroke are: African Americans, the elderly, and people with physical or cognitive disabilities. This study will help show which way to control high blood pressure works best for different groups of people. Health insurance administrators can use the results from this study to help stroke survivors optimize their overall health.
What is the research team doing?
The research team is testing two different ways to achieve healthy blood pressure after a stroke. Adult stroke survivors who are discharged home from the hospital and have high blood pressure are eligible to participate. Study participants will also need to be fluent in English or Spanish and have a smartphone with broadband access.
Nurses at nine hospitals that includes seven participating in PCORnet®, the National Patient-Centered Clinical Research Network, will identify eligible patients before they are discharged and invite them to a clinic that specializes in post-stroke care. At this clinic visit, researchers will confirm eligibility and invite them to be in the study. The team plans to enroll 3,200 people in the study.
People who consent to be in the study will be assigned at random to one of two groups. Both groups will receive intensive blood pressure management for six months so there is a benefit to being in each group.
Patients in one group, Intensive Tailored Telehealth Management (ITTM), will get:
- Care from a healthcare team to make blood pressure medication adjustments every two months by telemedicine
- A comprehensive care plan that focuses on blood pressure
- A professional health coach over the phone to help them manage medications and make changes to their diet and exercise, tailored to their care plan. Health reports will be sent to the patient and healthcare team.
- A Bluetooth blood pressure cuff that takes measurements at home and sends reports to the patient and healthcare team, as well as a watch that tracks steps per day
- Referral to community resources for any social or physical needs
Patients in the other group, Intensive Clinic Management (ICM), will get:
- In-person care from a healthcare team to make blood pressure medication adjustments once a month, until the patient’s blood pressure is in the healthy range, and then every two months
- A care plan for blood pressure and other stroke risk factors
- General health coaching from a coach related to diet, exercise, and stopping cigarette smoking
- Blood pressure logs
The study team will look at:
- The proportion of patients with healthy blood pressure, and how much patients’ blood pressure changed. A researcher will average three automated blood pressure measurements at a clinic visit at the start of the study and after six months.
- Death or hospitalization due to heart attack or stroke through electronic health records using the PCORnet Common Data Model, after one year
- Patients’ knowledge, skill, and confidence to manage their health using a validated survey after six months.
The team is partnering with:
- Social service providers
- IT experts
- Health system leaders who work with health insurance companies
- State policy makers
These research partners will help:
- Design the study and the study materials
- Ensure both ways of managing and measuring blood pressure are satisfactory to patients and clinicians
- Ensure patients and clinicians can use the technology
- Recruit patients
- Ensure there is an efficient workflow for clinicians and they follow all steps in the protocols
- Interpret the data and share results with the public
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.