RecruitingNot ApplicableNCT05321368

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


Sponsor

Johns Hopkins University

Enrollment

425 participants

Start Date

Oct 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a structured health program combining clinical care with community resources to improve heart health, blood sugar control, and weight in people at risk for heart disease and diabetes — especially in underserved communities. **You may be eligible if...** - You have cardiovascular risk factors (high blood pressure, high cholesterol, prediabetes, obesity) - You are 18 or older - You live in or near the community being served by the program **You may NOT be eligible if...** - You already have severe heart disease or uncontrolled diabetes requiring specialist care - You are unable or unwilling to participate in the program activities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALLINKED-HEARTS Program

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.


Locations(3)

Unity Health Care

Washington D.C., District of Columbia, United States

Johns Hopkins Community Physicians

Baltimore, Maryland, United States

Choptank Community Health Systems

Denton, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05321368


Related Trials