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

October 7, 2025 updated by: Johns Hopkins University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yvonne Commodore-Mensah, PhD, MSH
  • Phone Number: 443-614-1519
  • Email: ycommod1@jhu.edu

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20019
        • Recruiting
        • Unity Health Care
        • Contact:
          • Andrew Robie, MD
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins Community Physicians
        • Contact:
          • Sarah Rubin
      • Denton, Maryland, United States, 21629
        • Active, not recruiting
        • Choptank Community Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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., 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LINKED-HEARTS Program

Patients in the LINKED-HEARTS Program will be trained to measure their blood pressure with an Omron 10 series device using the Sphygmo telemonitoring app. The physician, pharmacist and Community Health Worker will have access to transmit data.

Community Health Workers will provide education on managing blood pressure; reinforce positive blood pressure self-management behaviors; deliver knowledge and skills to promote healthy chronic conditions; assist with linking clinical and administrative services; and link participants with community resources.

The study pharmacist will conduct telehealth visits, optimize pharmacologic therapy. The pharmacists will assess and address medication adherence to improve hypertension and diabetes control.
Behavioral: LINKED-HEARTS Program
The intervention arm will include training on home blood pressure monitoring, Sphygmo blood pressure telemonitoring app, Community Health Worker visit for education, counseling on lifestyles modification and Pharmacist to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.
No Intervention: Enhanced Usual Care
Patients in the Enhanced Usual Care Arm, will receive care as usual from their primary care provider and will be trained to measure their blood pressure with an Omron 10 series device. The staff in each participating community health center practice will be trained in blood pressure measurement best practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure
Time Frame: 12 months
Percent of patients with controlled Blood Pressure (<140/90 mm Hg).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure
Time Frame: Baseline and 12 months
Change from baseline in mean systolic blood pressure in millimeters of mercury (mmHg).
Baseline and 12 months
Change in Diastolic blood pressure
Time Frame: Baseline and 12 months
Change from baseline in diastolic blood pressure in mmHg.
Baseline and 12 months
Mean change in Hemoglobin A1c
Time Frame: Baseline and 12 months
Mean change from baseline in hemoglobin A1c (percent) in patients with a diagnosis of diabetes.
Baseline and 12 months
Percent with Hemoglobin A1c < 7.0
Time Frame: Baseline and 12 months
Change from baseline in the percent with hemoglobin A1c < 7.0 in patients with a diagnosis of diabetes.
Baseline and 12 months
Change in Body Mass Index (BMI)
Time Frame: Baseline and 12 months
Change from baseline in BMI (Kg/m^2).
Baseline and 12 months
Mean change in Estimated Glomerular Filtration Rate
Time Frame: Baseline and 12 months
Mean change from baseline in Estimated Glomerular Filtration Rate.
Baseline and 12 months
Change in Health-Related Quality of Life as assessed by the PROMIS 29
Time Frame: 12 months and 24 months
This outcome will be measured using Patient-Reported Outcomes Measurement Information System®, (PROMIS) 29 Profile v. 2.0
12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Yvonne Commodore-Mensah, PhD, MSH, RN, JHU School Of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Estimated)

October 21, 2026

Study Completion (Estimated)

April 22, 2027

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Estimated)

October 9, 2025

Last Update Submitted That Met QC Criteria

October 7, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00311760
  • P50MD017348 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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