Actively Recruiting
A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
Led by Johns Hopkins University · Updated on 2025-10-09
425
Participants Needed
3
Research Sites
183 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older as of date of data extraction
- Self-identify as non-Hispanic white, non-Hispanic Black/African American, and/or Hispanic
- Diagnosis of hypertension defined by ICD-10 code and systolic blood pressure of 140 mm Hg or higher on most recent clinic visit
- Diagnosis of diabetes or chronic kidney disease in addition to hypertension
- Receive primary medical care at one of the participating health systems
- Have a Maryland or Washington D.C. home address
You will not qualify if you...
- Younger than 18 years old
- Diagnosis of end-stage renal disease treated with dialysis
- Serious medical condition limiting life expectancy or requiring active management (e.g., cancer)
- Cognitive impairment or other conditions preventing participation
- Planning to leave the practice or move out of the geographic area within 24 months
- No longer consider the practice site as primary care location
- Unwillingness to provide informed consent
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Unity Health Care
Washington D.C., District of Columbia, United States, 20019
Actively Recruiting
2
Johns Hopkins Community Physicians
Baltimore, Maryland, United States, 21205
Actively Recruiting
3
Choptank Community Health Systems
Denton, Maryland, United States, 21629
Active, Not Recruiting
Research Team
Y
Yvonne Commodore-Mensah, PhD, MSH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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