Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

NCT ID: NCT05120544

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-21
• Study Completion Date: 2025-08-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

EXTEND

EXTEND participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS). Participants can review data and trends within the device apps and modify self-management practices accordingly. The EXTEND group continues chronic disease care with their existing providers during the study, and are instructed at baseline to address management questions via their primary clinics' established avenues (as would be the case for any patient using mobile monitoring in clinical practice).

Group Type: ACTIVE_COMPARATOR

EXTEND

Intervention Type: BEHAVIORAL

EXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers.

EXTEND Plus

EXTEND Plus participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS) for use as part of nurse-delivered intervention combining mobile monitoring, self-management support, and medication management. The intervention is administered by clinical registered nurses (RNs) from Duke Primary Care (DPC) or Duke Endocrinology. For the medication management component, RNs work with a study PharmD affiliated with the participant's clinic. The PharmD determines if medication changes are needed, and prescribes accordingly. The RNs deliver EXTEND Plus via scheduled telephone encounters throughout the 12-month intervention. The initial encounter frequency is every two weeks, but may be extended to every four weeks for patients achieving treatment goals.

Group Type: EXPERIMENTAL

EXTEND Plus

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

EXTEND

EXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• type 2 diabetes by International Classification of Diseases (ICD) code or treatment with glucose-lowering medication or mention in clinical notes
• Poor diabetes control as indicated by at least 1 HbA1c greater than or equal to 8.0% with NO HbA1c less than 8.0% over the past 6 months
• At least 1 appointment (office visit, appointment, initial consult, telemedicine) at primary clinic site over the past year
• hypertension by ICD code or treatment with blood pressure-lowering medication or mention in clinical notes
• poor hypertension control as indicated by a clinic systolic BP >140 AND/OR diastolic BP >90 over past year
• use of an Apple iPhone or Android smartphone
• can provide informed consent
• can read/speak English
• can provide informed consent

Exclusion Criteria

• dementia, psychosis, or life-limiting illness
• acute coronary event in past year
• hypoglycemic seizure/coma over the past year
• residence in a nursing home
• use of an insulin pump
• are or plan to become pregnant
• unable or unwilling to use necessary technology to participate in study

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan J Shaw, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Matthew Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Lee D, Yang Q, Crowley MJ, Hatch D, Pennington G, Matters D, Shaw RJ. Chronic Illness Self-Management Latent Profiles in Individuals With Comorbid Type 2 Diabetes and Hypertension. Sci Diabetes Self Manag Care. 2025 Jun;51(3):250-261. doi: 10.1177/26350106251336311. Epub 2025 May 14.

Reference Type: DERIVED

PMID: 40370006 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01NR019594-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO00107722

Identifier Type: -

Identifier Source: org_study_id