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Recruiting NCT05321368

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

No phase Interventional Hypertension High Blood Pressure Diabetes Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LINKED-HEARTS Program.
Who it may be relevant to
Registry conditions: Hypertension, High Blood Pressure, Diabetes, Chronic Kidney Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure [Time frame: 12 months]
Secondary outcome measures (7)
  • Change in Systolic Blood Pressure [Time frame: Baseline and 12 months]
  • Change in Diastolic blood pressure [Time frame: Baseline and 12 months]
  • Mean change in Hemoglobin A1c [Time frame: Baseline and 12 months]
  • Percent with Hemoglobin A1c < 7.0 [Time frame: Baseline and 12 months]
  • Change in Body Mass Index (BMI) [Time frame: Baseline and 12 months]
  • Mean change in Estimated Glomerular Filtration Rate [Time frame: Baseline and 12 months]
  • Change in Health-Related Quality of Life as assessed by the PROMIS 29 [Time frame: 12 months and 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 3 centers
  • Unity Health Care — Washington D.C.
  • Johns Hopkins Community Physicians — Baltimore
  • Choptank Community Health Systems — Denton

Publications

  • 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

Identifiers

NCT: NCT05321368 · IRB00311760 · P50MD017348

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗