Clinical trial NCT05809713: Heart to Heart: BP Control Partners
Official title: Carolina Consortium for Improved BP Control in Vulnerable Populations
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertension
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of North Carolina, Chapel Hill
First posted: 2023-04-12
Enrollment: 780
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria: Patients with:

* severe chronic kidney disease (eGFR \< 30 ml/min/1.73m2),
* substance abuse,
* difficulty with communication in English without an interpreter,
* dementia, mental illness or any condition that would limit ability to give informed consent
* rare patients living in very remote areas where cellular- enabled telemonitoring is not feasible will be excluded.
* 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.

Primary outcomes:
measure: Change in Systolic Blood Pressure (SBP) level at 6 months follow-up
timeFrame: 6-months
Secondary outcomes:
measure: Change in Systolic Blood Pressure (SBP) level at 12 months follow-up
timeFrame: 12 months
measure: Improved SBP Control at 6 and 12 months
timeFrame: 6 and 12 months follow-up
Other outcomes:
Locations:
city: Greenville
country: United States
facility: ECU Family Medicine Center
state: North Carolina
city: Wilmington
country: United States
facility: Cape Fear Clinic
state: North Carolina
Study officials:
affiliation: East Carolina University Brody School of Medicine
name: Doyle Cummings, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: