NCT05321368Active, not recruiting
A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 425 (estimated)
- First submitted
- 4 Apr 2022
- Start date
- 16 Oct 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Johns Hopkins University
- NCT number
- NCT05321368
What you commit to
- Study type: Interventional
- Planned participants: 425
- From 16 Oct 2023 to the primary completion date, 30 Sept 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of end-stage renal disease (ESRD) treated with dialysis
Other illness
- Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
- Cognitive impairment or other condition preventing participation in the intervention
Age
- Age \<18 years
Other
- Planning to leave the practice or move out of the geographic area in 24 months
- No longer consider the practice site their location for primary care
- Unwillingness to provide informed consent
Who the study is looking for
- 18 years of age as of date of data extraction,
- Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,
- 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.
- Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN
- Receives primary medical care at one of the participating health systems
- Have a Maryland and D.C. home address
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Community Physicians Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Choptank Community Health Systems Coordinator of this site? Confirm its status | Denton | United States | Unknown status |
| Unity Health Care Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.