Heart to Heart: BP Control Partners

Carolina Consortium for Improved BP Control in Vulnerable Populations

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension
• Intervention / Treatment: Other: Technology-enabled Team Care; Other: Enhanced Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 780
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • ECU Family Medicine Center
    • Wilmington, North Carolina, United States, 28401
      • Cape Fear Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Technology enabled Team Care; 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	Other: Technology-enabled Team Care; Patients randomized to the TTC arm will receive telehealth-enabled team-based care. The team will include a physician and/or advanced practice provider, a pharmacist with Certified Pharmacist Practitioner (CPP) status or similar skills in NC, and will incorporate brief nutritionist-directed lifestyle behaviors counseling (DASH diet; exercise) initially delivered every other week by phone for two months, followed by monthly calls (once SBP values achieve individualized goal and remain stable for 14 days) over 12 months supported by cellular enabled home BP monitoring.
Active Comparator: Enhanced Usual Care; Home BP monitoring device provided along with BP log, basic diet and exercise instruction, and care provided by the patient's usual doctor/provider	Other: Enhanced Usual Care; Patients randomized to the enhanced usual care (EUC) arm will receive telehealth enabled home BP monitoring equipment including set-up and instruction and basic hypertension-specific lifestyle (diet, exercise) instruction and materials at baseline, but will not receive telehealth-enabled team-based care, active home BP monitoring by a pharmacist, or detailed DASH intensive lifestyle counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure (SBP) level at 6 months follow-up	Change from baseline visit to six-months follow-up visit in measured SBP	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure (SBP) level at 12 months follow-up	Change from baseline visit to 12-months follow-up visit in measured SBP	12 months
Improved SBP Control at 6 and 12 months	Proportion with SBP < 140 mmHg in TTC intervention vs. enhanced usual care (EUC) pts. at 6 and 12 mo.	6 and 12 months follow-up

Collaborators and Investigators

• Sponsor: East Carolina University
• Collaborators: Patient-Centered Outcomes Research Institute; University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Doyle Cummings, Pharm.D., East Carolina University Brody School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2029

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IHS-2021C3-25060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Investigators will work with IRB and study sponsors to define a data sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No