Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Johns Hopkins University
- Enrollment
- 472
- Locations
- 20
- Primary Endpoint
- Change in systolic blood pressure
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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 18 months
- •Those who no longer consider the practice site the location where they receive primary care
- •Unwillingness to provide informed consent
Outcomes
Primary Outcomes
Change in systolic blood pressure
Time Frame: Baseline and 12 months
Change in systolic blood pressure in millimeters of mercury (mmHg) over a 12 month period.
Secondary Outcomes
- Change in diastolic blood pressure(Baseline and 12 months)