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A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities

RECRUITINGN/ASponsored by Johns Hopkins University
Actively Recruiting
PhaseN/A
SponsorJohns Hopkins University
Started2023-10-16
Est. completion2026-10-21
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

1. 18 years of age as of date of data extraction,
2. Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,
3. 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.
4. Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN
5. Receives primary medical care at one of the participating health systems
6. Have a Maryland and D.C. home address

Exclusion Criteria:

1. Age \<18 years
2. Diagnosis of end-stage renal disease (ESRD) treated with dialysis
3. Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
4. Cognitive impairment or other condition preventing participation in the intervention
5. Planning to leave the practice or move out of the geographic area in 24 months
6. No longer consider the practice site their location for primary care
7. Unwillingness to provide informed consent

Conditions4

Chronic Kidney DiseasesDiabetesHigh Blood PressureHypertension

Locations3 sites

District of Columbia

1 site
Unity Health Care
Washington D.C., District of Columbia, 20019
Andrew Robie, MD

Maryland

2 sites
Johns Hopkins Community Physicians
Baltimore, Maryland, 21205
Sarah Rubin
Choptank Community Health Systems
Denton, Maryland, 21629

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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