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

Study acronym: LINKED-HEARTS
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary completion date changed from estimate of Oct 21, 2026 to Sep 30, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Site details revised at 3 of 3 sites
    • Publications: details revised at 1 of 1 entry
  2. Notable Primary completion date: Oct 1, 2025 to Oct 21, 2026
    • Study completion date: Sep 1, 2026 to Apr 22, 2027
    v19
  3. Minor Study sites: 1 to 3v18
  4. Minor Enrollment target: 600 to 425v17
  5. Minor Eligibility criteria shortened, about 10 wordsv16
Show 14 earlier versionsHide 14 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 11, 2023 to Oct 16, 2023
    v15
  2. Notable Start date: Sep 11, 2023 to Oct 11, 2023v14
  3. Minor Start date: Aug 15, 2023 to Sep 11, 2023v13
  4. Notable Start date: Jul 15, 2023 to Aug 15, 2023v12
  5. Notable Start date: Jun 15, 2023 to Jul 15, 2023v11
  6. Notable Start date: May 15, 2023 to Jun 15, 2023v10
  7. Notable Start date: Mar 30, 2023 to May 15, 2023v9
  8. Notable Primary completion date: Oct 1, 2024 to Oct 1, 2025
    • Start date: Dec 30, 2022 to Mar 30, 2023
    v8
  9. Notable Start date: Nov 30, 2022 to Dec 30, 2022v7
  10. Minor Eligibility criteria shortened, about 52 wordsv6
  11. Notable Start date: Oct 31, 2022 to Nov 30, 2022v5
  12. Notable Start date: Sep 30, 2022 to Oct 31, 2022v4
  13. Notable Start date: Aug 31, 2022 to Sep 30, 2022v3
  14. Notable Start date: Jun 20, 2022 to Aug 31, 2022v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05321368
Lead Sponsor Johns Hopkins University
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Conditions
(from sponsor)
Hypertension, High Blood Pressure, Diabetes, Chronic Kidney Diseases
Related terms Diabetes Mellitus, Hypertension, Renal Insufficiency, Chronic
Enrollment 425 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov