Type 2 Diabetes
Conditions
Keywords
diabetes app, behavioral intervention, self-management, diabetes
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.
Interventions
BEHAVIORALapp-based nurse-led virtual diabetes care
A nurse-led, app-based behavioral intervention consisting of (1) education via MyChart messaging, (2) problem solving with an action plan via phone, and (3) remote patient monitoring via mySugr app to identify the need to adjust treatment
Sponsors
Rutgers, The State University of New Jersey
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
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.
Intervention model description
Clinic 1 starts enrollment and intervention on 4/1/2026, while Clinic 2 starts enrollment but intervention starts on 7/1/2026. We cannot deliver intervention the same time parallel step-wedge, give two clinics intervention can't deliver intervention same time
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control: glycated hemoglobin AIC | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Knowledge Test 2 (23 iems) for knowledge change | baseline, 3, 6, 9, and 12 months | This scale assesses the knowledge of individuals regarding diabetes management and self-care. 0 is minimal and 23 is maximal. Higher is better outcome reflecting high knowledge. |
| Diabetes Empowerment Scale Short 28 items for self-efficacy change | baseline, 3, 6, 9, and 12 months | The DES-28 has been validated and is considered a reliable tool for assessing the psychosocial aspects of diabetes management, making it useful for various educational and psychosocial interventions related to diabetes. 28 is minimal, 140 is max. Higher is better outcome, reflecting greater empowerment and self-efficacy in managing diabetes. |
| AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change | baseline, 3, 6, 9, and 12 months | It help healthcare providers identifies the social needs of their patients, which can inform interventions and resource allocation. 0 is minimal, 10 is max. Higher score is greater number of identified health-related social needs, which may suggest worse outcomes in terms of social determinants of health. |
| Brief Cope Inventory (28 items) for effective and ineffective ways to cope with stressful life events. | baseline, 3, 6, 9, and 12 months | The Brief Coping Inventory is a 28-item measure that assesses 14 distinct coping strategies, with two items representing each strategy. It provides insight into how individuals manage challenges related to diabetes and general life stressors. Each item is rated on a 4-point scale ranging from 1 ("not at all") to 4 ("a lot"). Scores for each coping strategy range from 2 to 8, with higher scores indicating greater use of that specific coping style. The total score for the full inventory ranges from 28 to 112, with higher overall scores reflecting a greater reliance on coping strategies across domains. |
| Diabetes Distress Scale (17 items) for quality of life change | baseline, 3, 6, 9, and 12 months | Measures emotional distress related to managing diabetes, with scores for each item ranging from 1 ("not a problem") to 6 ("a very serious problem"). It is a valuable tool for identifying patients who may need additional support in managing the emotional burdens associated with diabetes. 17 is minimal, 102 is max. Higher scores indicate greater diabetes-related distress, which is generally considered worse for overall well-being and diabetes management. Scores are typically categorized as little/no distress, moderate distress, or high distress to guide interventions. |
| Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes | baseline, 3, 6, 9, and 12 months | It is a reliable and valid tool for evaluating diabetes self-management behaviors and is useful in both research and clinical settings. 0 is minimal indicating no self-care activities performed, 11 is max indicating all self-care activities performed. Higher score indicate Measure consists of 11 items that assess various aspects of diabetes self-management. |
| Blood Glucose (BG) testing frequency change | baseline, 3, 6, 9, and 12 months | The number of blood glucose readings obtained from patient's home monitoring glucometer at baseline and the number of blood glucose readings listed in the diabetes app report at home for 3, 6, 9, and 12 months. |
| Diabetes Numeracy Test short (15 items) for knowledge change | baseline, 3, 6, 9, and 12 months | This test assesses diabetes-related numeracy skills that are essential for effective self-management of diabetes, such as interpreting blood glucose readings and calculating carbohydrate intake. 0-15, 0 is minimal with no correct answer, 15 is max. Higher is better outcome reflecting higher numeracy. |
Countries
United States
Contacts
CONTACTHelen NC Chen, PhD
CONTACTToya Williams, MPH
PRINCIPAL_INVESTIGATORHelen NC Chen, PhD
Rutgers School of Nursing
Outcome results
None listed