跳至主要内容
临床试验/NCT03436628
NCT03436628已完成不适用

Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens

Michigan State University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Change in Adherence to Self-management

研究概览

简要总结

Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age; their parents have to manage their child's condition. Eventually, the child must begin to take steps to transition to self-management. During the transition from parent to adolescent self-management, difficulties arise because adolescents may not be fully aware of, or want, to take responsibility for all the necessary tasks to successfully manage their T1D. Though there are other apps on the market to help with diabetes care, NONE do what the proposed app will do. The proposed self-management mobile app allows for monitoring the patients' T1D by linking their self-management information to their parents' cell phone, and thus also helps to bridge communication gaps. Prior research suggests that these are critical gaps that must be filled in order for successful transition in care to occur, the proposed app will help fill some of these gaps.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

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 A1c > 7;97
  • have had at least two outpatient visits in the past two years;
  • be treated at Sparrow for diabetes;
  • be fluent in English;
  • have a parent/guardian willing to participate;
  • be allowed to use a mobile phone for the study;
  • have permission from their care team.
  • The parent/guardian must:
  • have an adolescent with T1D who is 10 to 15 years old;
  • be fluent in English;
  • have daily access to email and the Internet (for appointment reminders and technical support).

排除标准

  • The exclusions for adolescents include:
  • significant medical conditions other than T1D;
  • being treated for thyroid disorders, celiac disease, or eating disorders;
  • 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 mental retardation).

结局指标

主要结局

Change in Adherence to Self-management

时间窗: Baseline and 3 months

Measured with the Diabetes Behavior Rating Scale (5 point likert scale, never-always); A higher value represents a better outcome

Change in Hemoglobin A1c (HbA1c)

时间窗: Baseline and 3 months

A laboratory test of HbA1c will be collected at the local hospital; A lower value represents a better outcome

次要结局

  • Change in Social Support(Baseline and 3 months)
  • Change in Self-Efficacy(Baseline and 3 months)
  • Change in Parental Monitoring(Baseline and 3 months)
  • Change in Conflict(Baseline and 3 months)
  • Parenting(Baseline)
  • Change in Quality of Life(Baseline and 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bree Holtz

Assistant Professor

Michigan State University

研究点 (2)

Loading locations...

相似试验