Heart to Heart: BP Control Partners
Public ClinicalTrials.gov record NCT05809713. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Carolina Consortium for Improved BP Control in Vulnerable Populations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05809713
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 780 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 9, 2023
- Primary completion
- Jul 29, 2027
- Completion
- Jul 29, 2029
- Last update posted
- Sep 12, 2023
2023 – 2029
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ECU Family Medicine Center | Greenville | North Carolina | 27834 | — |
| Cape Fear Clinic | Wilmington | North Carolina | 28401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05809713, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 12, 2023 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05809713 live on ClinicalTrials.gov.