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Led by Johns Hopkins University · Updated on 2025-10-09
425
Participants Needed
3
Research Sites
26 weeks
Total Duration
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
Y
Yvonne Commodore-Mensah, PhD, MSH
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Johns Hopkins University
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | LINKED-HEARTS Program (Intervention) | Enhanced Usual Care |
|---|---|---|
| What is this? | A combined behavioral, digital, and clinical team-based cardiometabolic health program that includes home blood pressure monitoring, telemonitoring app use, community health worker support, lifestyle counseling, and pharmacist-led medication review for improved hypertension management. | Clinical care for hypertension, diabetes, and chronic kidney disease as delivered at participating health systems. May include guideline-directed pharmacotherapy and disease management, but does not include structured telemonitoring, community health worker visits, or pharmacist-driven collaboration as in the intervention arm. |
| Role in the study | Intervention arm randomized to receive the LINKED-HEARTS Program for 12 months. | Control arm randomized to receive enhanced usual care within the clinical practice settings. |
| Primary use or purpose | To improve blood pressure control and reduce health disparities for adults with hypertension, diabetes, or chronic kidney disease through behavioral and digital interventions. | To provide routine clinical management for hypertension and related diseases according to the current standard in participating health systems. |
| How is it delivered or performed? | Participants receive training in home blood pressure monitoring, use a telemonitoring app, work with a community health worker, receive lifestyle counseling, and have pharmacist support for medication optimization over 12 months. | Participants receive regular clinical care, which may include routine blood pressure checks, medication management, and lifestyle advice during typical primary care visits. |
| Evidence status or maturity | Evidence is limited to ongoing clinical investigation; results from this trial are not yet established. The published protocol describes rationale and expected mechanisms. | Routine care is considered established and guideline-supported, but specific results for this population are not reported in the trial registry. |
| Important limitations | The program's effectiveness and safety are not yet demonstrated in peer-reviewed published results for the recruited population. Implementation relies on participant engagement and sustained access to devices, community health worker support, and pharmacist collaboration. Results of this trial will clarify impact. | Outcomes are dependent on usual clinical practice; without structured telemonitoring, community health intervention, or pharmacist optimization, improvements in blood pressure control may be limited compared to published intervention protocols. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
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
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/Johns Hopkins University
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
