Heart to Heart: BP Control Partners

Hypertension Clinical Trial

Official title:

Carolina Consortium for Improved BP Control in Vulnerable Populations

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05809713
• Other study ID #: IHS-2021C3-25060
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: July 30, 2029

Study information

• Verified date: September 2023
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 780
• Est. completion date: July 30, 2029
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	ECU Family Medicine Center	Greenville	North Carolina
United States	Cape Fear Clinic	Wilmington	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
East Carolina University	Patient-Centered Outcomes Research Institute, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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