Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

NCT05120544 | Completed DMC

• 2 other identifiers: PRO001077221R01NR019594-01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in blood pressure

  Baseline, 3, 6, 9, 12, 18 and 24 months

• Change in weight

  Baseline, 3, 6, 9, 12, 18 and 24 months

• Change is Diabetes Distress Scale

  Baseline, 6, 12, 18 and 24 months

• Change in Diabetes Self-Management Questionnaire

  Baseline, 6, 12, 18 and 24 months

• Change in Perceived Competence Scale

  Baseline, 6, 12, 18 and 24 months

Study Arms (2)

EXTEND

ACTIVE COMPARATOR

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 Plus

EXPERIMENTAL

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

Interventions

EXTEND Plus 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.

EXTEND Plus

EXTEND BEHAVIORAL

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

EXTEND

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 40370006 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ryan J Shaw, RN, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

• Matthew Crowley, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will occur following the baseline appointment. We will not blind participants to arm assignment because they will receive information on both arms during consent. In order to assure blinding of staff conducting outcome data collection, randomization will be managed by staff members not involved with outcome assessment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: April 21, 2022
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Within 3 years of study data publication.
• 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.

Locations

US (1)