MyT1DHero: A Randomized Controlled Trial of an mHealth Intervention to Improve Parent-child Communication and Adolescent Self-management of Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change from Baseline Diabetes Behavior Rating Scale at 12 months
研究概览
简要总结
The overall objective of the proposed research is to improve HbA1c, adherence to treatment plans, and family communication surrounding adolescents' self-management of T1D. The investigators will test the efficacy of the MyT1DHero app against an attention control group. This will allow investigators to better understand the health and psychosocial improvements being made through the app.
详细描述
This research seeks to realize the potential and test the efficacy of MyT1DHero to improve adolescent users' glycemic control and adherence to blood glucose monitoring. The investigators' goal is to help families receive more social support, and to improve diabetes knowledge, self-efficacy, family communication, and quality of life. The investigators further seek to decrease family conflict among children with T1D and their parents. In a 12-month RCT, investigators will randomize 166 adolescents and their parents to one of two groups: (1) attention control, or (2) the MyT1DHero app. Adolescents enrolled in the study will be 10-15 years old, and will have been living with T1D for <1 year or >5 years at the start of the study. The primary outcome will be a change in the participants' HbA1C from baseline levels at the start of the study, to levels measured after 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The adolescents must:
- •have a T1D diagnosis according to the ADA practice guidelines,
- •be 10 to 15 years old,
- •have had a diagnosis of T1D for at least six months,
- •have an HbA1c > 7,
- •have had at least two outpatient visits in the past two years,
- •be treated at Spectrum for diabetes,
- •be fluent in English,
- •have a parent/guardian willing to participate,
- •have and be allowed to use a mobile phone for the study, and
- •have permission from their care team to participate.
- •The parent/guardian must:
- •have an adolescent with T1D who is 10 to 15 years old,
- •be fluent in English, and
- •have daily access to email and the Internet (for appointment reminders and technical support).
排除标准
- •For the adolescents include:
- •significant medical conditions other than T1D,
- •being treated for thyroid disorders, celiac disease, or eating disorders, and
- •being in foster care.
- •Exclusion criteria for both the adolescents and parents/guardians include:
- •(a) a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and intellectual and developmental disabilities.
结局指标
主要结局
Change from Baseline Diabetes Behavior Rating Scale at 12 months
时间窗: Baseline and 12 months
A measure of diabetes adherence for both parent and child participants. Never (1) - Always(5) with a higher score indicating better adherence.
Change from Baseline HbA1c at 6 months and 12 months
时间窗: Baseline, 6 months, and 12 months
A laboratory test that measures how high blood glucose has been on average over the last 8-12 weeks - for child participants only (Lower number is best)
次要结局
- Change from Baseline PROMIS Item Bank v2.0 - Informational Support - Short Form 6a at 12 months(Baseline and 12 months)
- Change from Baseline PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a at 12 months(Baseline and 12 months)
- Change from Baseline NIH Toolbox Emotional Support (Ages 8-17) at 12 months(Baseline and 12 months)
- Change from Baseline Diabetes Empowerment Scale Short Form at 12 months(Baseline and 12 months)
- Change from Baseline PROMIS® Item Bank v.1.0 - General Self-Efficacy at 12 months(Baseline and 12 months)
- Change from Baseline NIH Toolbox Self-efficacy (ages 8-12) at 12 months(Baseline and 12 months)
- Change from Baseline Confidence in Diabetes Self-Care (Psychometric properties of a new measure of diabetes-specific self-efficacy in Dutch and U.S. patients with type 1 diabetes) at 12 months(Baseline and 12 months)
- Change from Baseline PROMIS® Item Bank v1.0 - General Life Satisfaction - Short Form 5a at 12 months(Baseline and 12 months)
- Change from Baseline PedsQL (Measurement Model for the Pediatric Quality of Life Inventory) at 12 months(Baseline and 12 months)
- Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Stigma - Short Form at 12 months(Baseline and 12 months)
- Change from Baseline Diabetes Conflict Scale at 12 months(Baseline and 12 months)
- Change from Baseline PROMIS® Parent Proxy Item Bank v1.0 - Family Relationships - Short Form 8a at 12 months(Baseline and 12 months)
- Change from Baseline Diabetes Family Behavior Scale at 12 months(Baseline and 12 months)
- Change from Baseline Family Functioning Scale at 12 months(Baseline and 12 months)
- Change from Baseline Impact on Family (Construct: Parental perceptions of the impact of a child's medical condition on the family) at 12 months(Baseline and 12 months)
- Change from Baseline Family Satisfaction (FSS) at 12 months(Baseline and 12 months)
- Change from Baseline Neuro-QOL Item Bank v1.0 -Anxiety - Short Form at 12 months(Baseline and 12 months)
- Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Anxiety - Short Form at 12 months(Baseline and 12 months)
- Change from Baseline Short-Form Outcome Expectations at 12 months(Baseline and 12 months)
- Usability and Satisfaction Questionnaire(12 months)
- Unified theory of acceptance and use of technology (UTAUT) Vantakesh, Morris, et al., 2003(12 months)
研究者
Bree Holtz
Assistant Professor
Michigan State University