NCT05321368 A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
| NCT ID | NCT05321368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 425 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2026-10-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 425 participants in total. It began in 2023-10-16 with a primary completion date of 2026-10-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Yvonne Commodore-Mensah, PhD, MSH, RN
PRINCIPAL INVESTIGATOR
JHU School Of Nursing
Frequently Asked Questions
Who can join the NCT05321368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05321368 currently recruiting?
Yes, NCT05321368 is actively recruiting participants. Contact the research team at ycommod1@jhu.edu for enrollment information.
Where is the NCT05321368 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States, Denton, United States.
Who is sponsoring the NCT05321368 clinical trial?
NCT05321368 is sponsored by Johns Hopkins University. The principal investigator is Yvonne Commodore-Mensah, PhD, MSH, RN at JHU School Of Nursing. The trial plans to enroll 425 participants.