iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 195
- 试验地点
- 4
- 主要终点
- Change in diabetes-specific quality of life as measured by The Type 1 Diabetes and Life Young Adult (T1DAL- Young Adult) for ages 18-25 or The Type 1 Diabetes and Life (T1DAL- Adult) for Ages 26-30.
研究概览
简要总结
This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-30 years
- •Diagnosis of type 1 diabetes (T1D)
- •T1D duration for one year or longer
- •Geographical location: residing in the United States.
排除标准
- •Inability to answer questions due to cognitive status.
- •Inability to read or understand English.
- •Diagnosis of insulin-dependent diabetes that is not T1D such as cystic fibrosis-related diabetes, maturity-onset diabetes of the young, or insulin-dependent type 2 diabetes.
研究组 & 干预措施
iHERO Resource Group
Toolkit consisting of micro-videos and supplemental online resources.
干预措施: iHERO Toolkit Resource (Behavioral)
Control
结局指标
主要结局
Change in diabetes-specific quality of life as measured by The Type 1 Diabetes and Life Young Adult (T1DAL- Young Adult) for ages 18-25 or The Type 1 Diabetes and Life (T1DAL- Adult) for Ages 26-30.
时间窗: Baseline, 1 month, 6 months, 12 months
T1DAL-Young Adult and T1DAL- Adult are scored on a scale of 0-100 with higher scores indicating better health related quality of life.
Change in HbA1c levels as measured by self-collect capillary HbA1c
时间窗: Baseline, 6 months, 12 months
Change in financial stress as measured by the Personal Financial Well-Being Scale© (PFW) Scale (PFW)
时间窗: Baseline, 1 month, 6 months, 12 months
The PFW is an 8-item scale used to measure financial stress with a Likert scale of 1-10 with 1 being no financial stress and 10 being an overwhelming level of financial stress. Lower scores (≤ 4.4) indicate high financial stress, while scores ranging from 4.5-6.4 indicate average stress, and scores ≥ 6.5 indicate low stress.
Change in health insurance literacy as measured by The Health Insurance Literacy Measure (HILM) Measure (HILM)
时间窗: Baseline, 1 month, 6 months, 12 months
The HILM is a 21-item measure used to rate confidence in selecting and using health insurance with 0 representing little confidence and 4 representing highest confidence. The scores of the items are summed and range from 0 to 84, with higher scores representing greater levels of health insurance literacy.
Change in transition navigation readiness as measured by the The Readiness for Emerging Adults with Diabetes Diagnosed in Youth (READDY) Navigation Subscale
时间窗: Baseline, 1 month, 6 months, 12 months
READDY navigation sub-scale scores of 1-3 indicate lower levels of confidence and scores of 4-5 indicate higher levels of confidence in healthcare navigation.
次要结局
未报告次要终点
研究者
Julia Blanchette
Assistant Professor of Medicine, Nurse Scientist
University Hospitals Cleveland Medical Center