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Tests pharmacist-led team care with home blood pressure monitoring for uncontrolled hypertension

Tests pharmacist phone support with home blood pressure checks in adults with high blood pressure.

Key facts

Who runs it
East Carolina University
Where
Greenville and Wilmington, United StatesSee the 2 sites
Trial code
Registry title
Heart to Heart: BP Control Partners
Status
Enrolling by invitation
People taking part
780 people, planned
Started
10 Aug 2023
Expected to end
30 Jul 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Technology-enabled Team Care
  • Enhanced Usual Care
Record updated
13 September 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with high blood pressure that has stayed uncontrolled. It tests home blood pressure monitoring with pharmacist support against enhanced usual care.

Age
Adults over 18 years old (the registry minimum age is 19 years).
Sex
All sexes can join; about 40% of participants are planned to be male.
Disease stage
Diagnosis of essential hypertension, with a documented history of uncontrolled blood pressure (mean SBP ≥ 140 mmHg at primary care visits over the last year) and SBP ≥ 140 mmHg at enrollment (average of 2 research-grade measurements).

Main reasons for not taking part

  • Severe chronic kidney disease (eGFR < 30 ml/min/1.73m2)
  • Substance abuse
  • Difficulty communicating in English without an interpreter
  • Dementia, mental illness or any condition that limits the ability to give informed consent
  • Pregnancy before randomization

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • dementia, mental illness or any condition that would limit ability to give informed consent
  • severe chronic kidney disease (eGFR < 30 ml/min/1.73m2),
  • 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

Where in United States

  • ECU Family Medicine CenterGreenville, United StatesEnrolling by invitation
  • Cape Fear ClinicWilmington, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Technology enabled Team CareTreatment being tested

    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

  • Enhanced Usual CareExisting treatment, for comparison

    Home BP monitoring device provided along with BP log, basic diet and exercise instruction, and care provided by the patient's usual doctor/provider

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Carolina Consortium for Improved BP Control in Vulnerable Populations
Plain-language title
Tests pharmacist-led team care with home blood pressure monitoring for uncontrolled hypertensionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
13 September 2023