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Clinical Trial Summary

The purpose of this study is to investigate whether the self-management of diabetes and hypertension can be improved with the use of mobile monitoring devices and nursing support.


Clinical Trial Description

EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) seeks to address evidence gaps that prevent practical use of mobile monitoring-enabled telehealth for clinic-refractory chronic diseases, with an initial focus on patients who have poorly controlled type 2 diabetes and hypertension despite receiving clinic-based care. Because our population has already proven refractory to usual care, we will conduct an active comparator randomized trial (N=220) of two 12-month interventions: 1) mobile monitoring as a self management tool (EXTEND); and 2) a nurse-delivered intervention incorporating mobile monitoring, self-management support, and medication management (EXTEND Plus). For the medication management component, the nurse works with a Clinical Pharmacist to optimize medications. Our primary effectiveness analyses of the 12-month EXTEND interventions will occur at 12 months, and persistence of effect will be examined out to 24 months (Aim 1). We will inform future scaling and dissemination in clinical practice by interviewing key stakeholders (n=40) regarding implementation barriers/facilitators and comparing program costs and reimbursement pathways (Aim 2). Finally, this proposal will also allow us to examine a novel application for mobile monitoring technologies, as tools for predicting patient safety events; we will examine combined mobile monitoring and electronic health record data as a means to predict patient safety events in the EXTEND cohort over 24 months (Aim 3). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05120544
Study type Interventional
Source Duke University
Contact
Status Active, not recruiting
Phase N/A
Start date April 21, 2022
Completion date July 1, 2025

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