Nurse-led App Intervention to Improve Glycemic Control in Patients With Insulin-treated Type 2 Diabetes on Medicaid
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Glycemic control: glycated hemoglobin AIC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnancy
- •Patients with cognitive impairment who will be screened with the Six-Item Screener to Identify Cognitive Impairment Among Potential Research Subjects.
研究组 & 干预措施
Experimental with intervention
Intervention starts at enrollment
干预措施: app-based nurse-led virtual diabetes care (Behavioral)
Delayed Intervention
Intervention delivery 3 months after enrollment
干预措施: app-based nurse-led virtual diabetes care (Behavioral)
结局指标
主要结局
Glycemic control: glycated hemoglobin AIC
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Helen NC Chen PhD, FNP
PHD RN CRNP
Rutgers, The State University of New Jersey