Expanding Technology-Enabled Nurse Delivered Chronic Disease Care (EXTEND)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: EXTEND; Behavioral: EXTEND Plus

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Behavioral: EXTEND; EXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Change in blood sugar (glucose) attached to hemoglobin. Validated point-of-care or lab-based test.	Baseline, 3, 6, 9, 12, 18 and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Measure taken at clinic with standard arm cuff. Measurement is the average of two readings, on the same arm, taken 10 minutes apart.	Baseline, 3, 6, 9, 12, 18 and 24 months
Change in weight	Measurement taken with lab scale, when patient is lightly clothed, shoes off.	Baseline, 3, 6, 9, 12, 18 and 24 months
Change is Diabetes Distress Scale	Measure of diabetes distress and burden using the Diabetes Distress Scale (DDS): 17 items, Scale 1-6. Scoring: Average. Higher score indicates higher distress level.	Baseline, 6, 12, 18 and 24 months
Change in Diabetes Self-Management Questionnaire	Measure of diabetes self-care. Diabetes Self-Management Questionnaire (DSMQ): 16 items, Scale 0-3. Scoring: Sum and transform to fall between 0-10. Higher score indicates more effective self-care.	Baseline, 6, 12, 18 and 24 months
Change in Perceived Competence Scale	Measure of diabetes self-efficacy and capacity. Perceived Competence Scale (PCS): 4 items, Scale 1-7. Scoring: average (1-7) Higher score indicates greater self-efficacy.	Baseline, 6, 12, 18 and 24 months
Change in medication non-adherence	Validated self-report measure using Voils' medication non-adherence measure.	Baseline, 6, 12, 18 and 24 months
Change in diabetes knowledge	Diabetes Knowledge Questionnaire (DKQ) is a 24-item validated measure.	Baseline, 6, 12, 18 and 24 months
Change in hypertension knowledge	Hypertension Knowledge Measure (HKM) is an 11-item validated measure.	Baseline, 6, 12, 18 and 24 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Ryan J Shaw, RN, PhD, Duke University School of Nursing; Principal Investigator: Matthew Crowley, MD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Actual): August 13, 2025
• Study Completion (Actual): August 13, 2025

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PRO00107722; 1R01NR019594-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Our data will be made available for use by investigators not associated with the proposed study within 3 years after the primary results have been published. We will prepare a clear and searchable documentation of the database including a data dictionary, and its linkage to the pertinent study protocols and forms so that diverse investigators can make effective use of the data. For investigators interested in prospective collaborations, we will explore other options to provide support.
• IPD Sharing Time Frame: Within 3 years of study data publication.
• IPD Sharing Access Criteria: For all prospective opportunities (e.g., access to datasets, collaborative studies), we will widely advertise them on Duke Websites and at appropriate scientific meetings.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No