NCT05120544

Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 Persistent Poorly Controlled Diabetes Mellitus (PPDM) and hypertension. 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). The medication management is a care team approach where the nurse works with a Pharmacist who has prescribing rights to optimize medications for the patients. This proposal will also allow us to examine a novel application for mobile monitoring technologies, as tools for predicting patient safety events. Aim 1: Compare the effectiveness of the two 12-month EXTEND interventions for PPDM and hypertension. Hypothesis 1a: Compared to EXTEND, EXTEND Plus will improve primary (HbA1c) and secondary outcomes (e.g., blood pressure, weight, self-management measures) at 12 months; Hypothesis 1b: The relative effects of each intervention will be sustained at 24 months; Hypothesis 1c: Subgroup analyses will identify characteristics associated with high responsiveness to each intervention. Aim 2: Guide scaling and dissemination of the EXTEND interventions by: (A) interviewing patients and stakeholders to clarify implementation barriers, facilitators and process requirements; (B) comparing intervention costs against potential reimbursement mechanisms; and (C) understanding the role of climate change and other social drivers of health on diabetes self-management and intervention engagement. Aim 3: Explore the value of combining mobile monitoring and EHR data for predicting patient safety events (hospitalizations, emergency visits) in the EXTEND study cohort over 24 months. Participants will monitor their data using a suite of remote monitoring devices. Data will be analyzed with PACE by our team. If participants are randomized to the telehealth arm, these data will be reviewed by a RN during a telehealth visit to aid in clinical decision making.

Conditions

• Diabetes Mellitus, Type 2
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	EXTEND Plus	The EXTEND Plus approach builds patient self-management capacity by focusing on knowledge, self-efficacy, and goal setting (using an RN-delivered, module-based approach). All material is at an 8th grade reading level. Module topics include, but are not limited to, use of self-monitoring of blood glucose (SMBG), BP monitoring, developing a diet plan, medication adherence, hypoglycemia and hypotension self-management, and self-managing insulin. In addition, this intervention component addresses diet and activity self-management during each encounter.
BEHAVIORAL	EXTEND	EXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers.

Timeline

• Start date: 2022-04-21
• Primary completion: 2025-08-13
• Completion: 2025-08-13
• First posted: 2021-11-15
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States