A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities

Last updated: October 7, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Foot Ulcers

Diabetic Neuropathy

Diabetic Kidney Disease

Treatment

LINKED-HEARTS Program

Clinical Study ID

NCT05321368
IRB00311760
P50MD017348
  • Ages > 18
  • All Genders

Study 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

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/orHispanic,

  3. Diagnosis of Hypertension (HTN) defined by International Classification of Diseases,Tenth code (ICD-10 code) and elevated systolic blood pressure (SBP) measure (≥140 mmHg) on their most recent clinic visit.

  4. Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), inaddition to HTN

  5. Receives primary medical care at one of the participating health systems

  6. Have a Maryland and D.C. home address

Exclusion

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 activemanagement (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

Study Design

Total Participants: 425
Treatment Group(s): 1
Primary Treatment: LINKED-HEARTS Program
Phase:
Study Start date:
October 16, 2023
Estimated Completion Date:
April 22, 2027

Connect with a study center

  • Unity Health Care

    Washington, District of Columbia 20019
    United States

    Site Not Available

  • Unity Health Care

    Washington D.C. 4140963, District of Columbia 4138106 20019
    United States

    Active - Recruiting

  • Johns Hopkins Community Physicians

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Choptank Community Health Systems

    Denton, Maryland 21629
    United States

    Site Not Available

  • Johns Hopkins Community Physicians

    Baltimore 4347778, Maryland 4361885 21205
    United States

    Active - Recruiting

  • Choptank Community Health Systems

    Denton 4353075, Maryland 4361885 21629
    United States

    Site Not Available

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