Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05321368

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 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypertension Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders High Blood Pressure Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unity Health Care, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age as of date of data extraction,
  • Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,
  • 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.
  • Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN
  • Receives primary medical care at one of the participating health systems
  • Have a Maryland and D.C. home address

Exclusion criteria

  • Age <18 years
  • Diagnosis of end-stage renal disease (ESRD) treated with dialysis
  • Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
  • Cognitive impairment or other condition preventing participation in the intervention
  • Planning to leave the practice or move out of the geographic area in 24 months
  • No longer consider the practice site their location for primary care
  • Unwillingness to provide informed consent

Treatment and study plan

LINKED-HEARTS Program

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: Baseline and 12 months

    Change from baseline in mean systolic blood pressure in millimeters of mercury (mmHg).

  2. Change in Diastolic blood pressure

    Time frame: Baseline and 12 months

    Change from baseline in diastolic blood pressure in mmHg.

  3. 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.

  4. 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.

  5. Change in Body Mass Index (BMI)

    Time frame: Baseline and 12 months

    Change from baseline in BMI (Kg/m^2).

  6. Mean change in Estimated Glomerular Filtration Rate

    Time frame: Baseline and 12 months

    Mean change from baseline in Estimated Glomerular Filtration Rate.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yvonne Commodore-Mensah, PhD, MSH

CONTACT

[email protected]

443-614-1519

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: LINKED-HEARTS

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 11, 2022
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.