A program to improve heart and metabolic health using telemonitoring and community support

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

This study is testing a new program that uses home blood pressure monitoring and community support to help adults with high blood pressure and diabetes or kidney disease improve their heart and metabolic health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 425 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 3 sites (Washington D.C., District of Columbia and 2 other locations)
• Trial ID: NCT05321368 on ClinicalTrials.gov

What this trial studies

The LINKED-HEARTS Program aims to enhance cardiometabolic health by integrating home blood pressure monitoring with a telemonitoring platform and community health worker support. This multi-level intervention targets adults with uncontrolled hypertension and either type 2 diabetes or chronic kidney disease across various community health centers. Participants will be randomly assigned to either enhanced usual care or an intervention group that includes telemonitoring and team-based care to improve health outcomes. The program seeks to address health disparities in high-risk populations through comprehensive management of chronic conditions.

Who should consider this trial

Good fit: Ideal candidates for this program are adults aged 18 and older with uncontrolled hypertension and either type 2 diabetes or chronic kidney disease who receive care at participating health systems.

Not a fit: Patients with end-stage renal disease requiring dialysis or serious medical conditions that limit life expectancy may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could significantly improve blood pressure control, blood sugar levels, and kidney function in patients with multiple chronic conditions.

How similar studies have performed: Other studies have shown success with similar integrated care approaches, indicating potential for positive outcomes in managing chronic conditions.

Eligibility criteria

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

Where this trial is running

Washington D.C., District of Columbia and 2 other locations

• Unity Health Care — Washington D.C., District of Columbia, United States (RECRUITING)
• Johns Hopkins Community Physicians — Baltimore, Maryland, United States (RECRUITING)
• Choptank Community Health Systems — Denton, Maryland, United States (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Yvonne Commodore-Mensah, PhD, MSH, RN — JHU School Of Nursing
• Study coordinator: Yvonne Commodore-Mensah, PhD, MSH

Conditions: Hypertension, High Blood Pressure, Diabetes, Chronic Kidney Diseases