A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health
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 c
| Condition(s) | Hypertension, High Blood Pressure, Diabetes, Chronic Kidney Diseases |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 Om |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Johns Hopkins University |
| Locations | Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States; Denton, Maryland, United States |
| Start date | 2023-10-16 |
| NCT ID | NCT05321368 |
| Official listing | https://clinicaltrials.gov/study/NCT05321368 |