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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The LINKED-BP Program is a patient-centered, multi-level intervention linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo) that links with all Bluetooth-enabled validated blood pressure (BP) devices, support from community health workers (CHWs), and BP measurement training at community health centers serving high-risk adults to prevent stage 2 hypertension (BP ≥ 140/90 mm Hg). The LINKED-BP Program study will recruit a total of 600 adults (30 from each practice) with elevated BP (120-129/<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) across 20 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors (HBPM) and will be managed by the patients' primary care clinicians as usual; and (2) the LINKED-BP Program or "intervention arm," which will include training of patients on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. The intervention period for each study participant is 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LINKED-BP Program | Experimental | Patients in the LINKED-BP Program will be trained to measure their BP with an Omron 10 series device. Patients who have smartphones will download the patient facing app and receive a unique link from the study team. Patients who do not own a smartphone will be provided one with a data plan for the duration of the study. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal. CHWs will support patients by: (1) providing education on how to manage BP through self-monitoring and practicing dietary modification and exercise; (2) reinforcing positive BP self-management through follow-up encounters; (3) assisting with linkages to existing clinical and administrative services; and (4) link participants with community resources to address health-related social needs. The staff in each participating community health center practice will be trained in blood pressure measurement best practices. |
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| Enhanced Usual Care | No Intervention | Patients in the Enhanced Usual Care Arm, will receive care as usual from thier primary care provider and will be trained to measure their BP with an Omron 10 series device. The staff in each participating community health center practice will be trained in blood pressure measurement best practices. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LINKED-BP Program | Behavioral | The intervention arm will include training on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. Patients will be trained to measure their BP in the morning and evening for 7 days. Patients enter data using Bluetooth device transmission or manual entry. Guidance is provided on accurate BP measurement. The app stores and securely relays data to the cloud. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal. Other components of usual care at the practices may include dietary counseling, on-site clinical pharmacists, social workers, case managers as needed for BP follow up, and assistance with medications and appointments as needed. The intervention period for each study participant is 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure | Change in systolic blood pressure in millimeters of mercury (mmHg) over a 12 month period. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in diastolic blood pressure | Change in diastolic blood pressure in millimeters of mercury (mmHg) over a 12 month period. | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Commodore-Mensah, PhD, MHS, RN | JHU School Of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Community Physicians I Street | Washington D.C. | District of Columbia | 20005 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37061796 | Derived | Commodore-Mensah Y, Liu X, Ogungbe O, Ibe C, Amihere J, Mensa M, Martin SS, Crews D, Carson KA, Cooper LA, Himmelfarb CR. Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program. Am J Hypertens. 2023 Apr 15;36(5):273-282. doi: 10.1093/ajh/hpad001. |
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| Unity Upper Cardozo Health Center |
| Washington D.C. |
| District of Columbia |
| 20009 |
| United States |
| Unity Brentwood Health Center | Washington D.C. | District of Columbia | 20018 | United States |
| Unity East of the River | Washington D.C. | District of Columbia | 20019 | United States |
| Unity Minnesota Avenue Health Center | Washington D.C. | District of Columbia | 20019 | United States |
| Unity Parkside Health Center | Washington D.C. | District of Columbia | 20019 | United States |
| Unity Anacostia Health Center | Washington D.C. | District of Columbia | 20020 | United States |
| Johns Hopkins Community Physicians Remington | Baltimore | Maryland | 21211 | United States |
| Johns Hopkins Community Physicians Bowie | Bowie | Maryland | 20715 | United States |
| Johns Hopkins Community Physicians Brandywine | Brandywine | Maryland | 20613 | United States |
| Choptank Fassett Magee Medical and Cambridge Dental Center | Cambridge | Maryland | 21613 | United States |
| Choptank Denton Health Center | Denton | Maryland | 21629 | United States |
| Johns Hopkins Community Physicians Greater Dundalk | Dundalk | Maryland | 21222 | United States |
| Choptank Easton Health Center | Easton | Maryland | 21601 | United States |
| Choptank Federalsburg Medical and Dental Center | Federalsburg | Maryland | 21632 | United States |
| Johns Hopkins Community Physicians Fulton | Fulton | Maryland | 20759 | United States |
| Choptank Goldsboro | Goldsboro | Maryland | 21636 | United States |
| Johns Hopkins Community Physicians White Marsh | Nottingham | Maryland | 21236 | United States |
| Choptank Bay Hundred | Saint Michaels | Maryland | 21663 | United States |
| Johns Hopkins Community Physicans Charles County-White Plains | White Plains | Maryland | 20695 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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