Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

Study Overview
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Brief Summary
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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
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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 patients who have poorly controlled type 2 diabetes and hypertension despite receiving clinic-based care. 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). For the medication management component, the nurse works with a Clinical Pharmacist to optimize medications. Our primary effectiveness analyses of the 12-month EXTEND interventions will occur at 12 months, and persistence of effect will be examined out to 24 months (Aim 1). We will inform future scaling and dissemination in clinical practice by interviewing key stakeholders (n=40) regarding implementation barriers/facilitators and comparing program costs and reimbursement pathways (Aim 2). Finally, this proposal will also allow us to examine a novel application for mobile monitoring technologies, as tools for predicting patient safety events; we will examine combined mobile monitoring and electronic health record data as a means to predict patient safety events in the EXTEND cohort over 24 months (Aim 3).

Official Title
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Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Behavioral: EXTEND Plus
* Behavioral: EXTEND


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EXTEND<br>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<br>* EXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers.<br>|
| Experimental: EXTEND Plus<br>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<br>* 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.<br>|

What is the study measuring?
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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 |