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

NCT05321368 | Recruiting

• 2 other identifiers: IRB00311760P50MD017348
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 3

Brief 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

Hypertension; High Blood Pressure; Diabetes; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure

  Percent of patients with controlled Blood Pressure (\<140/90 mm Hg).

  12 months

Secondary Outcomes (7)

• Change in Systolic Blood Pressure

  Baseline and 12 months

• Change in Diastolic blood pressure

  Baseline and 12 months

• Mean change in Hemoglobin A1c

  Baseline and 12 months

• Percent with Hemoglobin A1c < 7.0

  Baseline and 12 months

• Change in Body Mass Index (BMI)

  Baseline and 12 months

Study Arms (2)

LINKED-HEARTS Program

EXPERIMENTAL

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

Enhanced Usual Care

NO INTERVENTION

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.

Interventions

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.

LINKED-HEARTS Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Unity Health Care

Washington D.C., District of Columbia, 20019, United States

RECRUITING

Johns Hopkins Community Physicians

Baltimore, Maryland, 21205, United States

RECRUITING

Choptank Community Health Systems

Denton, Maryland, 21629, United States

ACTIVE NOT RECRUITING

Related Publications (1)

• Commodore-Mensah Y, Chen Y, Ogungbe O, Liu X, Metlock FE, Carson KA, Echouffo-Tcheugui JB, Ibe C, Crews D, Cooper LA, Himmelfarb CD. Design and rationale of the cardiometabolic health program linked with community health workers and mobile health telemonitoring to reduce health disparities (LINKED-HEARTS) program. Am Heart J. 2024 Sep;275:9-20. doi: 10.1016/j.ahj.2024.05.008. Epub 2024 May 15.

  PMID: 38759910 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Yvonne Commodore-Mensah, PhD, MSH, RN

  JHU School Of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Commodore-Mensah, PhD, MSH

CONTACT

443-614-1519; ycommod1@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 11, 2022
• Study Start: October 16, 2023
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): April 22, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)