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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, High Blood Pressure, Diabetes, Chronic Kidney Diseases

Intervention / Treatment
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* Behavioral: LINKED-HEARTS Program


Participation Criteria
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Eligibility Criteria
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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 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 Upper arm circumference >50 cm (maximum limit of the extra-large BP cuff) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LINKED-HEARTS Program<br>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<br>* 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.<br>|
| No Intervention: Enhanced Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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