High Blood Pressure, Hypertension
Conditions
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.
Interventions
BEHAVIORALLINKED-BP Program
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.
Sponsors
American Heart Association
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure | Baseline and 12 months | Change in systolic blood pressure in millimeters of mercury (mmHg) over a 12 month period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in diastolic blood pressure | Baseline and 12 months | Change in diastolic blood pressure in millimeters of mercury (mmHg) over a 12 month period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYvonne Commodore-Mensah, PhD, MHS, RN
JHU School Of Nursing
Outcome results
None listed