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Completed

NCT Number: NCT05120544

Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. Change in HbA1c

    Time frame: Baseline, 3, 6, 9, 12, 18 and 24 months

    Change in blood sugar (glucose) attached to hemoglobin. Validated point-of-care or lab-based test.

Secondary outcomes

  1. Change in blood pressure

    Time frame: Baseline, 3, 6, 9, 12, 18 and 24 months

    Measure taken at clinic with standard arm cuff. Measurement is the average of two readings, on the same arm, taken 10 minutes apart.

  2. Change in weight

    Time frame: Baseline, 3, 6, 9, 12, 18 and 24 months

    Measurement taken with lab scale, when patient is lightly clothed, shoes off.

  3. Change is Diabetes Distress Scale

    Time frame: Baseline, 6, 12, 18 and 24 months

    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.

  4. Change in Diabetes Self-Management Questionnaire

    Time frame: Baseline, 6, 12, 18 and 24 months

    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.

  5. Change in Perceived Competence Scale

    Time frame: Baseline, 6, 12, 18 and 24 months

    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.

  6. Change in medication non-adherence

    Time frame: Baseline, 6, 12, 18 and 24 months

    Validated self-report measure using Voils' medication non-adherence measure.

  7. Change in diabetes knowledge

    Time frame: Baseline, 6, 12, 18 and 24 months

    Diabetes Knowledge Questionnaire (DKQ) is a 24-item validated measure.

  8. Change in hypertension knowledge

    Time frame: Baseline, 6, 12, 18 and 24 months

    Hypertension Knowledge Measure (HKM) is an 11-item validated measure.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: EXTEND

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2021
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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