HypertensionNCT05809713
Heart to Heart: BP Control Partners
A study testing Technology-enabled Team Care in people with Hypertension, run by East Carolina University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Technology-enabled Team Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2023to 30 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
ECU Family Medicine Center
Greenville, North Carolina, 27834
Cape Fear Clinic
Wilmington, North Carolina, 28401
About this study
Official title: 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:
- 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).
- Assess the potential for heterogeneity of treatment effects by race, age, sex, and social deprivation index (secondary).
- 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).
Read more
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.
- Conditions
- Hypertension
- Being tested
- Technology-enabled Team Care, Enhanced Usual Care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-enabled Team CareOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-months
Secondary outcomes (2)
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
Measured: 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.
Measured: 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start10 Aug 2023
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial
- Masking
- None (open label)
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Doyle Cummings, Pharm.D., Principal investigator, East Carolina University Brody School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809713
- Sponsor's protocol ID
- IHS-2021C3-25060
- Status last verified
- Sep 2023
- First submitted
- 30 Mar 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Investigators will work with IRB and study sponsors to define a data sharing plan
Publications
Cummings DM, Halladay J, Warner C, Richman E, Hart S, Sastre L, Pullen-Smith B, Peri K, Howard G; Heart to Heart Study Writing Group. Design, rationale, and baseline findings from a patient-centered randomized trial of technology-enabled team care: the heart-2-heart BP control partners study. Contemp Clin Trials. 2026 Sep 10:108469. doi: 10.1016/j.cct.2026.108469. Online ahead of print.
PubMed 42722229
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carolina Consortium for Improved BP Control in Vulnerable Populations
- ClinicalTrials.gov ID
- NCT05809713
- Acronym / sponsor ID
- IHS-2021C3-25060
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of North Carolina, Chapel Hill
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- Assess the potential for heterogeneity of treatment effects by race, age, sex, and social deprivation index (secondary).
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| Technology enabled Team Care | Experimental | Other: Technology-enabled Team CareOngoing 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 Care | Active comparator | Other: Enhanced Usual CareHome BP monitoring device provided along with BP log, basic diet and exercise instruction, and care provided by the patient's usual doctor/provider |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-enabled Team CarePatients 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. | Other | Technology enabled Team Care |
| Enhanced Usual CarePatients 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. | Other | Enhanced Usual Care |
Primary outcome
Change in Systolic Blood Pressure (SBP) level at 6 months follow-up
Time frame: 6-months
Change from baseline visit to six-months follow-up visit in measured SBP
2 secondary outcomes
Change in Systolic Blood Pressure (SBP) level at 12 months follow-up
Time frame: 12 months
Improved SBP Control at 6 and 12 months
Time frame: 6 and 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 42722229Cummings DM, Halladay J, Warner C, Richman E, Hart S, Sastre L, Pullen-Smith B, Peri K, Howard G; Heart to Heart Study Writing Group. Design, rationale, and baseline findings from a patient-centered randomized trial of technology-enabled team care: the heart-2-heart BP control partners study. Contemp Clin Trials. 2026 Sep 10:108469. doi: 10.1016/j.cct.2026.108469. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Investigators will work with IRB and study sponsors to define a data sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doyle Cummings, Pharm.D. principal investigator
East Carolina University Brody School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-enabled Team Care in people with Hypertension, run by East Carolina University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (SBP) level at 6 months follow-up (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.