NCT05809713Enrolling by invitation
Heart to Heart: BP Control Partners
Carolina Consortium for Improved BP Control in Vulnerable Populations
Source: ClinicalTrials.gov · Last updated 13 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 780 (estimated)
- First submitted
- 30 Mar 2023
- Start date
- 10 Aug 2023
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- East Carolina University
- Diseases
- High blood pressure
- NCT number
- NCT05809713
What you commit to
- Study type: Interventional
- Planned participants: 780
- From 10 Aug 2023 to the primary completion date, 30 Jul 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnancy; female participants will be asked to report pregnancy status during pre-screening and at study baseline. Participants who report pregnancy prior to randomization will be excluded from the study. If the participant becomes pregnant during the study, prescribed medication(s) will be rapidly tapered or immediately discontinued, as indicated and the patient referred back to their primary care provider for follow-up.
Other illness
- dementia, mental illness or any condition that would limit ability to give informed consent
Lab values
- severe chronic kidney disease (eGFR \< 30 ml/min/1.73m2),
Other
- substance abuse,
- difficulty with communication in English without an interpreter,
- rare patients living in very remote areas where cellular- enabled telemonitoring is not feasible will be excluded.
Who the study is looking for
- Hispanic and non-Hispanic black (≥50%) and white (≤50%) adults (\>18yr. old; 40% male)
- diagnosis of essential hypertension,
- a documented history of uncontrolled hypertension (mean SBP ≥ 140 mmHg from primary care office visits over the last year) and
- elevated SBP (≥ 140 mmHg) (average of 2 research-grade measurements) at the time of enrollment.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ECU Family Medicine Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Cape Fear Clinic Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
Related publications
- Design, rationale, and baseline findings from a patient-centered randomized trial of technology-enabled team care: the heart-2-heart BP control partners study.Contemp Clin Trials · 2026 · PMID 42722229
This page is information, not medical advice. Discuss any trial with your doctor.