Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

Hypertension Clinical Trial

— EXTEND  

Official title:

Expanding Technology-Enabled Nurse Delivered Chronic Disease Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05120544
• Other study ID #: PRO00107722
• Secondary ID: 1R01NR019594-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in weight	Measurement taken with lab scale, when patient is lightly clothed, shoes off.	Baseline, 3, 6, 9, 12, 18 and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in medication non-adherence	Validated self-report measure using Voils' medication non-adherence measure.	Baseline, 6, 12, 18 and 24 months
Secondary	Change in diabetes knowledge	Diabetes Knowledge Questionnaire (DKQ) is a 24-item validated measure.	Baseline, 6, 12, 18 and 24 months
Secondary	Change in hypertension knowledge	Hypertension Knowledge Measure (HKM) is an 11-item validated measure.	Baseline, 6, 12, 18 and 24 months