Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure

Study Overview
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Brief Summary
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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.

Official Title
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Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure

Conditions
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Hypertension, High Blood Pressure

Intervention / Treatment
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* Behavioral: LINKED-BP Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age as of the date of data extraction Self-identify as non-Hispanic white, non-Hispanic African-American or Hispanic Have elevated BP (120-129/<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) (defined by AHA's 2017 hypertension clinical guidelines) Receives primary medical care at one of the participating community health centers and primary care practices Exclusion Criteria: Age <18 years Prescribed antihypertensive medication Diagnosis of end-stage renal disease (ESRD) Condition which interferes with outcome measurement (e.g., dialysis) Serious medical condition which either limits life expectancy or requires active management (e.g., cancer) Patients with serious cognitive impairment or other conditions preventing their participation in the intervention Upper arm circumference >50 cm (maximum limit of the extra-large BP cuff) Those planning to leave the practice or move out of the geographic area in 24 months Those who no longer consider the practice site the location where they receive primary care Unwillingness to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LINKED-BP Program<br>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. | Behavioral: LINKED-BP Program<br>* 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.<br>|
| No Intervention: Enhanced Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |