Clinical trial NCT05120544: Expanding Technology-Enabled Nurse Delivered Chronic Disease Care
Official title: Expanding Technology-Enabled Nurse Delivered Chronic Disease Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-11-15
Enrollment: 220
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline, 3, 6, 9, 12, 18 and 24 months
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline, 3, 6, 9, 12, 18 and 24 months
measure: Change in weight
timeFrame: Baseline, 3, 6, 9, 12, 18 and 24 months
measure: Change is Diabetes Distress Scale
timeFrame: Baseline, 6, 12, 18 and 24 months
measure: Change in Diabetes Self-Management Questionnaire
timeFrame: Baseline, 6, 12, 18 and 24 months
measure: Change in Perceived Competence Scale
timeFrame: Baseline, 6, 12, 18 and 24 months
measure: Change in medication non-adherence
timeFrame: Baseline, 6, 12, 18 and 24 months
measure: Change in diabetes knowledge
timeFrame: Baseline, 6, 12, 18 and 24 months
measure: Change in hypertension knowledge
timeFrame: Baseline, 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Ryan J Shaw, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Matthew Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: