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.
18 years of age as of date of data extraction,
Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,
Diagnosis of Hypertension (HTN) defined by International Classification of Diseases, Tenth code (ICD-10 code) and elevated systolic blood pressure (SBP) measure (≥140 mm Hg) on their most recent clinic visit.
Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN
Age <18 years
Diagnosis of end-stage renal disease (ESRD) treated with dialysis
Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
Cognitive impairment or other condition preventing participation in the intervention
Parallel
LINKED-HEARTS Program
BehavioralThe 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.
Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure
Percent of patients with controlled Blood Pressure (\<140/90 mm Hg).
Change in Systolic Blood Pressure
Change from baseline in mean systolic blood pressure in millimeters of mercury (mmHg).
Change in Diastolic blood pressure
Change from baseline in diastolic blood pressure in mmHg.
Mean change in Hemoglobin A1c
Mean change from baseline in hemoglobin A1c (percent) in patients with a diagnosis of diabetes.
Percent with Hemoglobin A1c < 7.0
Change from baseline in the percent with hemoglobin A1c \< 7.0 in patients with a diagnosis of diabetes.
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Johns Hopkins University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
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