Technology-Enabled Team Care for High Blood Pressure
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, a pharmacist will work with you to adjust your medications as needed to manage your blood pressure.
What data supports the effectiveness of the treatment Technology-enabled Team Care for High Blood Pressure?
Is Technology-Enabled Team Care for High Blood Pressure safe for humans?
How is the Technology-enabled Team Care treatment for high blood pressure different from other treatments?
Technology-enabled Team Care is unique because it involves a team of healthcare professionals, like nurses and pharmacists, working together to manage high blood pressure, rather than relying on a single doctor. This collaborative approach aims to improve blood pressure control more effectively than traditional methods.1241112
What is the purpose of this trial?
The goal of this clinical trial is to compare a new model of care that uses cellular-enabled home blood pressure (BP) telemonitoring and combines it with team-based BP control using a pharmacist to help manage BP medications and to give patients advice on diet and exercise, to an enhanced usual care group that only receives the monitoring device and basic instructions, in individuals with a history of uncontrolled hypertension. The main question\[s\] it aims to answer are:1. Among patients with a history of uncontrolled hypertension, evaluate the impact of team-based care using technology-enabled monitoring on improving goal-directed systolic blood pressure (SBP) levels relative to enhanced usual care (primary).2. Assess the potential for heterogeneity of treatment effects by race, age, sex, and social deprivation index (secondary).3. Examine the impact of the intervention on hypertension self-efficacy, medication adherence, timeliness of medication change, satisfaction with care, adoption of home BP monitoring, and the change in mean BP in diverse patients, many of whom have adverse social determinants of health (SDOH) (secondary/exploratory).Both groups will be asked to check their BP at home using a cellular-enabled home BP monitoring device that's provided. Patients in the Technology enabled Team Care (TTC) intervention group will have regular phone calls from a clinically trained and experienced pharmacist that works with their doctor/provider and who has reviewed their home BP readings. This pharmacist will help them adjust their medicines, provide brief nutrition and physical activity advice, and may refer them for help with any social challenges (not enough proper food, transportation problems, etc.) that they may be experiencing. An enhanced usual care group will serve as the comparison group and will receive the BP cuff monitoring device and basic instructions but will not receive ongoing monitoring or team care as described above.Researchers will compare the effect of the TTC intervention model to enhanced usual care to assess the impact on SBP levels at 6 and 12 months follow-up, as well as on a variety of patient-reported outcomes.
Research Team
Doyle Cummings, Pharm.D.
Principal Investigator
East Carolina University Brody School of Medicine
Eligibility Criteria
This trial is for adults over 18 with a history of uncontrolled high blood pressure, particularly Hispanic and non-Hispanic black (majority) and white individuals. Participants must have had an average systolic BP of at least 140 mmHg in the past year and speak English without needing an interpreter. Those with severe kidney disease, dementia, substance abuse issues, or pregnant women are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ongoing team-based, pharmacist-led telephonic management of uncontrolled high blood pressure involving cellular-enabled home BP monitoring, medications, diet and exercise, and referral for social problems
Follow-up
Participants are monitored for changes in systolic blood pressure and other outcomes at 6 and 12 months
Treatment Details
Interventions
- Enhanced Usual Care
- Technology-enabled Team Care
Find a Clinic Near You
Who Is Running the Clinical Trial?
East Carolina University
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of North Carolina, Chapel Hill
Collaborator