Heart to Heart: BP Control Partners

NCT05809713 | Enrolling By Invitation

• 1 other identifier: IHS-2021C3-25060
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 2

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. 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. 2.Assess the potential for heterogeneity of treatment effects by race, age, sex, and social deprivation index (secondary).
3. 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).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Systolic Blood Pressure (SBP) level at 12 months follow-up

  12 months

• Improved SBP Control at 6 and 12 months

  6 and 12 months follow-up

Study Arms (2)

Technology enabled Team Care

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

Technology-enabled Team Care OTHER

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.

Technology enabled Team Care

Enhanced Usual Care OTHER

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Carolina University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

ECU Family Medicine Center

Greenville, North Carolina, 27834, United States

Location

Cape Fear Clinic

Wilmington, North Carolina, 28401, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Doyle Cummings, Pharm.D.

  East Carolina University Brody School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized trial

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2029
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

US (2)