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临床试验/NCT02746627
NCT02746627已完成不适用

Positive Psychology to Improve Adherence in Adolescents With Type 1 Diabetes

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Glycemic Control (HbA1c)

研究概览

简要总结

Problems with diabetes management in adolescents with type 1 diabetes are common - occurring at rates as high as 93% - and have serious health consequences, including poor blood sugar control and risk for later complications. Therefore, the investigators proposed to test a positive psychology intervention for adolescents with type 1 diabetes aimed at increasing motivation for diabetes management; specifically, to increase the frequency of blood glucose monitoring. This intervention will boost positive mood in adolescents (age 13-17) through tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a way to improve motivation for diabetes management. In addition, this study will explore the use of technology, by comparing telephone-administered vs. automated text-messaging versions of the intervention, to determine which mode of delivery is more appealing, convenient, and beneficial for adolescents in managing their diabetes.

Participants and parents will complete questionnaires on mood and diabetes management during a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes management will be collected from participants' electronic medical records.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with type 1 diabetes for at least 6 months
  • HbA1c between 8-12%
  • Speak and read English
  • Caregiver living with child

排除标准

  • Other uncontrolled health conditions

研究组 & 干预措施

Education

Active Comparator

Participants receive educational materials in the mail every 2 weeks for 8 weeks.

干预措施: Education (Behavioral)

Positive Affect - Text

Experimental

Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.

干预措施: Positive Affect (Behavioral)

Positive Affect - Text

Experimental

Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations, and gift cards) by SMS. Participants also receive educational materials in the mail every 2 weeks for 8 weeks.

干预措施: Education (Behavioral)

Positive Affect - Phone

Experimental

Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.

干预措施: Positive Affect (Behavioral)

Positive Affect - Phone

Experimental

Participants receive positive affect intervention (weekly reminders to use gratitude, self-affirmations, parental affirmations) by phone. Participants receive small gifts in the mail every 2 weeks for 8 weeks. educational materials in the mail every 2 weeks for 8 weeks.

干预措施: Education (Behavioral)

结局指标

主要结局

Glycemic Control (HbA1c)

时间窗: 6 months

HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is \<7.5%.

次要结局

  • Frequency of Blood Glucose Monitoring(6 months)
  • Family Conflict(6 months)
  • Diabetes-Related Quality of Life(6 months)
  • Positive Affect(6 months)
  • Coping(6 months)

研究者

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

Sarah Jaser

Assistant Professor

Vanderbilt University Medical Center

研究点 (2)

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