The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 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 and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
425
The intervention arm will include training on home blood pressure monitoring, Sphygmo blood pressure telemonitoring app, Community Health Worker visit for education, counseling on lifestyles modification and Pharmacist to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.
Unity Health Care
Washington D.C., District of Columbia, United States
RECRUITINGJohns Hopkins Community Physicians
Baltimore, Maryland, United States
RECRUITINGChoptank Community Health Systems
Denton, Maryland, United States
ACTIVE_NOT_RECRUITINGBlood Pressure Control as assessed by percentage of participants with controlled Blood Pressure
Percent of patients with controlled Blood Pressure (\<140/90 mm Hg).
Time frame: 12 months
Change in Systolic Blood Pressure
Change from baseline in mean systolic blood pressure in millimeters of mercury (mmHg).
Time frame: Baseline and 12 months
Change in Diastolic blood pressure
Change from baseline in diastolic blood pressure in mmHg.
Time frame: Baseline and 12 months
Mean change in Hemoglobin A1c
Mean change from baseline in hemoglobin A1c (percent) in patients with a diagnosis of diabetes.
Time frame: Baseline and 12 months
Percent with Hemoglobin A1c < 7.0
Change from baseline in the percent with hemoglobin A1c \< 7.0 in patients with a diagnosis of diabetes.
Time frame: Baseline and 12 months
Change in Body Mass Index (BMI)
Change from baseline in BMI (Kg/m\^2).
Time frame: Baseline and 12 months
Mean change in Estimated Glomerular Filtration Rate
Mean change from baseline in Estimated Glomerular Filtration Rate.
Time frame: Baseline and 12 months
Change in Health-Related Quality of Life as assessed by the PROMIS 29
This outcome will be measured using Patient-Reported Outcomes Measurement Information System®, (PROMIS) 29 Profile v. 2.0
Time frame: 12 months and 24 months
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