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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental with intervention | Experimental | Intervention starts at enrollment |
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| Delayed Intervention | Other | Intervention delivery 3 months after enrollment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| app-based nurse-led virtual diabetes care | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control: glycated hemoglobin AIC | Electronic health record extracted lab test drawn at baseline, 3, 6, 9, and 12 months | baseline, 3, 6, 9, and 12 months |
| Glycemic control - the rate of pre-prandial blood glucose readings in target range | 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. | baseline, 3, 6, 9, and 12 months |
| Glycemic control - the rate of peak postprandial blood glucose reading in target range | 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. | baseline, 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Knowledge Test 2 (23 iems) for knowledge change | 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. | baseline, 3, 6, 9, and 12 months |
| Diabetes Empowerment Scale Short 28 items for self-efficacy change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen NC Chen, PhD | Contact | (908) 466-3953 | helen.nc.chen@rutgers.edu | |
| Toya Williams, MPH | Contact | â€(732) 235-7380‬ | toya.williams@rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Helen NC Chen, PhD | Rutgers School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Health Family Medicine at Monument Square | Recruiting | New Brunswick | New Jersey | 08901 | United States |
IPD will not be shared. Each participant will be given a unique study identification number that will be used on all study forms and data files. Each participant's identifying data will be separated from the study data. All data will be de-identified with a participant code number. The code linking a participant to their code number will be maintained in a separate file on a secure server at Rutgers (e.g., Microsoft Teams, Box).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 14, 2026 | Apr 23, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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
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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.
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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. |
| baseline, 3, 6, 9, and 12 months |
| AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change | 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. | baseline, 3, 6, 9, and 12 months |
| Brief Cope Inventory (28 items) for effective and ineffective ways to cope with stressful life events. | 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. | baseline, 3, 6, 9, and 12 months |
| Diabetes Distress Scale (17 items) for quality of life change | 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. | baseline, 3, 6, 9, and 12 months |
| Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes | 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. | baseline, 3, 6, 9, and 12 months |
| Blood Glucose (BG) testing frequency change | 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. | baseline, 3, 6, 9, and 12 months |
| Diabetes Numeracy Test short (15 items) for knowledge change | 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. | baseline, 3, 6, 9, and 12 months |
| University Medical Group General Internal Medicine | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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