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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: Recruiting NA study of Hypertension and Diabetes, sponsored by Johns Hopkins University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent of patients with controlled Blood Pressure (\<140/90 mm Hg).
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 |
What NCT05321368 shows while recruiting
NCT05321368 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05321368's enrollment target sits among peer trials
425 141st of 470 higher than 329 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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