Virtual Diabetes Care for Adults With Type 2 Diabetes on Medicaid and Insulin Therapy

Официальное название

Nurse-led App Intervention to Improve Glycemic Control in Patients With Insulin-treated Type 2 Diabetes on Medicaid

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое app-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

Первичные конечные точки

• Glycemic control: glycated hemoglobin AIC [Срок оценки: baseline, 3, 6, 9, and 12 months]
• Glycemic control - the rate of pre-prandial blood glucose readings in target range [Срок оценки: baseline, 3, 6, 9, and 12 months]
• Glycemic control - the rate of peak postprandial blood glucose reading in target range [Срок оценки: baseline, 3, 6, 9, and 12 months]

Вторичные конечные точки (8)

• Diabetes Knowledge Test 2 (23 iems) for knowledge change [Срок оценки: baseline, 3, 6, 9, and 12 months]
• Diabetes Empowerment Scale Short 28 items for self-efficacy change [Срок оценки: baseline, 3, 6, 9, and 12 months]
• AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change [Срок оценки: baseline, 3, 6, 9, and 12 months]
• Brief Cope Inventory (28 items) for effective and ineffective ways to cope with stressful life events. [Срок оценки: baseline, 3, 6, 9, and 12 months]
• Diabetes Distress Scale (17 items) for quality of life change [Срок оценки: baseline, 3, 6, 9, and 12 months]
• Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes [Срок оценки: baseline, 3, 6, 9, and 12 months]
• Blood Glucose (BG) testing frequency change [Срок оценки: baseline, 3, 6, 9, and 12 months]
• Diabetes Numeracy Test short (15 items) for knowledge change [Срок оценки: baseline, 3, 6, 9, and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Pregnancy
• Patients with cognitive impairment who will be screened with the Six-Item Screener to Identify Cognitive Impairment Among Potential Research Subjects.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• Rutgers Health Family Medicine at Monument Square — New Brunswick
• University Medical Group General Internal Medicine — New Brunswick

Идентификаторы

NCT: NCT06814184 · Pro2025000096

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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