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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Improved SBP Control at 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria: Patients with:
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| Name | Affiliation | Role |
|---|---|---|
| Doyle Cummings, Pharm.D. | East Carolina University Brody School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECU Family Medicine Center | Greenville | North Carolina | 27834 | United States | ||
| Cape Fear Clinic |
Investigators will work with IRB and study sponsors to define a data sharing plan
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized trial
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| 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. |
|
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 |
| Wilmington |
| North Carolina |
| 28401 |
| United States |