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

Not Applicable

Recruiting

• Conditions: Diabetes; High Blood Pressure; Hypertension; Chronic Kidney Diseases
• Interventions: Behavioral: LINKED-HEARTS Program

• Registration Number: NCT05321368
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-11
• Study Start: 2023-10-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-10-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LINKED-HEARTS Program	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.

Primary Outcome Measures

Name	Time	Method
Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure	12 months	Percent of patients with controlled Blood Pressure (\<140/90 mm Hg).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Choptank Community Health Systems; 🇺🇸 Denton, Maryland, United States