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LINKED-HEARTS Program for Cardiometabolic Disorders (LINKED-HEARTS Trial)

N/A

Recruiting

Led By Yvonne Commodore-Mensah, PhD, MSH, RN

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

18 years of age as of date of data extraction

Must not have

Diagnosis of end-stage renal disease (ESRD) treated with dialysis

Cognitive impairment or other condition preventing participation in the intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve blood pressure, blood sugar, and kidney function for 600 adults with uncontrolled hypertension, diabetes, or CKD through team-based care, home monitoring, and telehealth.

Who is the study for?

Adults with uncontrolled high blood pressure and either type 2 diabetes or chronic kidney disease, who are non-Hispanic white, Black/African American, or Hispanic. They must be getting care at participating health centers in Maryland and not have plans to move soon. People with severe medical conditions like cancer or those on dialysis for end-stage renal disease cannot join.

What is being tested?

The LINKED-HEARTS Program tests a new way to manage high blood pressure and related conditions using home monitoring linked to a telemonitoring platform, community health workers, pharmacists' support via telehealth, and an app called Sphygmo. The goal is better control of blood pressure, sugar levels, and kidney function.

What are the potential side effects?

Since this trial focuses on monitoring and managing existing conditions rather than testing new medications, side effects may be minimal. However, there could be potential issues related to the use of technology such as privacy concerns or stress from constant health tracking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with high blood pressure.

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I am 18 years old or older.

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I have diabetes or chronic kidney disease and high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on dialysis for end-stage kidney disease.

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I do not have any mental conditions that prevent me from participating.

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My upper arm circumference is more than 50 cm.

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I have a serious health condition that needs ongoing treatment.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in Body Mass Index (BMI)

Change in Diastolic blood pressure

Change in Health-Related Quality of Life as assessed by the PROMIS 29

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LINKED-HEARTS ProgramExperimental Treatment1 Intervention

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.

Group II: Enhanced Usual CareActive Control1 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.

0 / 8Eligibility criteria met