MACCHE #1

ClinicalTrials.gov link

Diseases or Conditions Being Studied
Hypertension, high blood pressure, diabetes, chronic kidney disease

Communities of Focus
Maryland residents who self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic

Study Site
Maryland

Intervention or Treatment
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.

Abstract

Innovation in chronic disease management is urgently needed to effectively control hypertension (HTN) and diabetes, conditions which affect millions of Americans. Uncontrolled HTN and diabetes cause cardiovascular disease, stroke, chronic kidney disease (CKD), and premature death. However, these conditions are poorly controlled despite the availability of effective and affordable therapy. A pressing priority is reducing disparities in the management and control of chronic diseases and making primary care more convenient for underserved populations. Black and Hispanic adults are disproportionately affected by HTN and diabetes than White adults. They also experience more adverse social determinants of health, including a lack of access to reliable transportation and fragmented access to primary care. Team-based care including community health workers and pharmacists are “best practices” in improving HTN and diabetes control. Telehealth has become a cornerstone of efforts to minimize disruptions in primary care and can be enhanced with remote patient monitoring devices. The COVID-19 pandemic has spurred efforts to increase access to timely and appropriate care through re-engineering primary care to be patient-centered and digitally-enabled. Sphygmo Home, a remote patient telemonitoring solution that links with validated blood pressure (BP) and glucose monitoring devices is a promising solution to improve patient's self-management of HTN and diabetes. We have designed the LINKED-HEARTS Program, an innovative, theoretically derived, patient-centered, multi-level intervention to address individual and community-level social determinants that affect chronic disease management. The LINKED-HEARTS Program focuses on addressing structural issues of access and includes a self-measured BP(SMBP) and blood glucose telemonitoring platform; team-based care including a pharmacist and community health worker and provider-level interventions.

Specific Aims

Using a hybrid type I effectiveness-implementation design, our proposed specific aims are 1) To compare the effect of the LINKED-HEARTS Program versus SMBP alone in improving BP control (systolic BP<140/90 mm Hg) and improving patient-centered outcomes at 6 and 12 months, in a cluster-randomized controlled trial of adults with uncontrolled HTN and either diabetes or CKD. 2) To use the Pragmatic Robust Implementation and Sustainability Model (PRISM) to evaluate the reach, adoption, maintenance of the LINKED-HEARTS program at 12 and 24 months post-randomization and explore contextual factors that associated with adoption and maintenance of the program. We will enroll 600 adults, clustered in 16 practices including federally qualified healthcare centers. Through early and continued stakeholder engagement with health system leaders, providers, patients, and our community, we seek to close the wide “know-do-gap” and reduce chronic disease disparities. We also propose a comprehensive dissemination strategy to reach critical audiences and achieve buy-in and policy change.