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NCT05321368 · ClinicalTrials.gov registry record · NA
A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
A NA study of Hypertension and Diabetes, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 425
- Enrollment target
- 3
- Study locations
NCT05321368 is a NA study of Hypertension and Diabetes that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 425 participants, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (88% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT05321368, a NA study of Hypertension and Diabetes, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 425 participants
- Enrollment target
- 3
- Study locations
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.
Conditions Studied
Interventions
- BEHAVIORAL LINKED-HEARTS Program
Study Locations (3)
Maryland
- Johns Hopkins Community Physicians - Baltimore
- Choptank Community Health Systems - Denton
District of Columbia
- Unity Health Care - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2023-10-16 |
| Est. Completion | 2027-04-22 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05321368
The ClinicalTrials.gov registry entry for NCT05321368 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 425 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (88% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which LINKED-HEARTS Program is the first listed.
NCT05321368 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Maryland, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05321368 about?
NCT05321368 is a clinical study titled "A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities". 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 ou...
What is the current status of trial NCT05321368?
This trial is currently recruiting. It is a NA study. The enrollment target is 425 participants. The study started on 2023-10-16. Estimated completion is 2027-04-22.
What conditions does trial NCT05321368 study?
This clinical trial studies the following conditions: Hypertension, Diabetes, Chronic Kidney Diseases, High Blood Pressure.
What interventions are being tested in trial NCT05321368?
The interventions under investigation include: LINKED-HEARTS Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT05321368?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05321368 being conducted?
This trial has 3 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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