Nurse-led App Intervention to Improve Glycemic Control in Patients With Insulin-treated Type 2 Diabetes on Medicaid
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Glycemic control: glycated hemoglobin AIC
Study Overview
Brief Summary
This 12-month pilot tests a nurse-led, app-based intervention to improve diabetes self-management for Medicaid patients. It includes MyChart messaging to give education, phone help on problem-solving with clinicians, and using a diabetes app to track data. The study aims to enhance self-management behaviors through health technology.
Detailed Description
Guided by the Self- and Family Management Framework, which specifies facilitators and barriers to self- management behaviors, this project tests strategies for delivering virtual diabetes care to help Medicaid patients and clinicians use health information technology to support self-management behaviors. It is a 12-month pilot nurse-led, app-based behavioral intervention consisting of three evidence-based interventions: (1) education on A1C results and goal-setting via MyChart, the Epic electronic health record's patient portal; (2) a problem-solving action plan developed collaboratively by clinicians and patients; and (3) remote monitoring via mySugr, a top- rated diabetes app, to track blood glucose and identify the need for treatment adjustments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
Both clinics collect baseline at the same time for both clinics. Masking participants that we tell participants that we will reach out to when intervention rolls out. Clinic 2 will roll out 3 months later than Clinic 1.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A1C >7 for age 18-64, A1C>8 for age 65 or older within 12 months prior baseline
- •A1C>7 for age 18-64, A1c>8 for age 65 or older at baseline
- •Medicaid recipient or dual Medicaid and Medicare recipient
- •Age 18 or older
- •Type 2 diabetes
- •On insulin therapy
- •Owning and using Android or iOS smartphone for at least 6 months
- •English proficiency
- •Adequate vision to read text messages on their current smartphone
- •Smartphone use proficiency. Smartphone proficiency will be self-reported and determined by telephone as the ability to use a smartphone in ways other than emailing, texting, and making phone calls.
Exclusion Criteria
- •Pregnancy
- •Patients with cognitive impairment who will be screened with the Six-Item Screener to Identify Cognitive Impairment Among Potential Research Subjects.
Arms & Interventions
Experimental with intervention
Intervention starts at enrollment
Intervention: app-based nurse-led virtual diabetes care (Behavioral)
Delayed Intervention
Intervention delivery 3 months after enrollment
Intervention: app-based nurse-led virtual diabetes care (Behavioral)
Outcomes
Primary Outcomes
Glycemic control: glycated hemoglobin AIC
Time Frame: baseline, 3, 6, 9, and 12 months
Electronic health record extracted lab test drawn at baseline, 3, 6, 9, and 12 months
Glycemic control - the rate of pre-prandial blood glucose readings in target range
Time Frame: baseline, 3, 6, 9, and 12 months
Home monitoring glucometer at baseline and diabetes app report containing blood glucose readings at home for 3, 6, 9, and 12 months. It is calculated from the number of BG that met the target divided by the total number of BG tested.
Glycemic control - the rate of peak postprandial blood glucose reading in target range
Time Frame: baseline, 3, 6, 9, and 12 months
Blood glucose reading obtained from patient's home monitoring glucometer at baseline and diabetes app report containing blood glucose readings at home for 3, 6, 9, and 12 months. It is calculated from the number of BG that met the target divided by the total number of BG tested.
Secondary Outcomes
- Diabetes Distress Scale (17 items) for quality of life change(baseline, 3, 6, 9, and 12 months)
- Brief Cope Inventory (28 items) for effective and ineffective ways to cope with stressful life events.(baseline, 3, 6, 9, and 12 months)
- Blood Glucose (BG) testing frequency change(baseline, 3, 6, 9, and 12 months)
- Diabetes Knowledge Test 2 (23 iems) for knowledge change(baseline, 3, 6, 9, and 12 months)
- Diabetes Empowerment Scale Short 28 items for self-efficacy change(baseline, 3, 6, 9, and 12 months)
- AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change(baseline, 3, 6, 9, and 12 months)
- Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes(baseline, 3, 6, 9, and 12 months)
- Diabetes Numeracy Test short (15 items) for knowledge change(baseline, 3, 6, 9, and 12 months)
Investigators
Helen NC Chen PhD, FNP
PHD RN CRNP
Rutgers, The State University of New Jersey