Actively Recruiting
Led by Johns Hopkins University · Updated on 2025-10-09
425
Participants Needed
3
Research Sites
26 weeks
Total Duration
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups: one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.
CONDITIONS
A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive the LINKED-HEARTS Program including training on home blood pressure monitoring, use of a blood pressure telemonitoring app, education and counseling from Community Health Workers, and pharmacist telehealth visits to optimize medication therapy.
Regular telehealth and in-person visits with Community Health Workers and pharmacists throughout the program
Duration - Up to 12 additional months
Participants are monitored for health outcomes such as blood pressure control, diabetes management, and quality of life after completing the intervention.
Periodic assessments up to 24 months from baseline
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
Y
Yvonne Commodore-Mensah, PhD, MSH
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Yvonne Commodore-Mensah, Yuling Chen, Oluwabunmi Ogungbe...
https://pubmed.ncbi.nlm.nih.gov/38759910