跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT01783327
NCT01783327已完成不适用

Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes

Yale University4 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2012年7月最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
4
主要终点
Change from baseline hemoglobin A1c over 12 months
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the use of a state-of the art internet psycho-educational program in clinical practice (Teens-Connect), compared to use of a standard and widely available internet diabetes program for youth (Planet D™) in a mixed-method randomized clinical trial design.

详细描述

The aims are:

  1. To evaluate the efficacy and cost-effectiveness of provider-prescribed Teens-Connect (TEENCOPE™+Managing Diabetes) in pediatric diabetes practice compared to prescription of Planet D™.

The hypotheses to be studied are:

  1. Youth who participate in Teens-Connect will have better metabolic control (A1c) and quality of life (QOL) than those who participate in Planet D.
  2. These effects will be mediated by improvements in stress/coping, self-efficacy, diabetes problem-solving, and self-management.
  3. Teens-Connect prescribed by providers in diabetes clinics will be a cost-effective approach to reduce A1c and improve quality-adjusted life years (QALYs) for youth with T1D.
  4. To compare the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the two provider-prescribed psycho-educational internet programs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
11 Years 至 14 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with type 1 diabetes for at least 6 months
  • •Age 11 to 14 years
  • •English-speaking
  • •Parent/guardian consent to participate in study

排除标准

  • •*Previous exposure to TEENCOPE and/or Managing Diabetes

结局指标

主要结局

Change from baseline hemoglobin A1c over 12 months

时间窗: Baseline, 6 weeks, 6 months, 12 months

Change from baseline quality of life over 12 months

时间窗: Baseline, 6 weeks, 6 months, 12 months

次要结局

  • Change from baseline coping/Stress over 12 months(Baseline, 6 weeks, 6 months, 12 months)
  • Change from baseline quality adjusted life years over 12 months(Baseline, 6 weeks, 6 months, 12 months)
  • Change from baseline problem-solving over 12 months(Baseline, 6 weeks, 6 months, 12 months)
  • Change from baseline self-efficacy over 12 months(Baseline, 6 weeks, 6 months, 12 months)
  • Change from baseline self-management over 12 months(Baseline, 6 weeks, 6 months, 12 months)
  • Costs(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验

已完成
不适用
Web-based Psycho-Educational Program to Support Carers of Alzheimer's PatientsAlzheimer Disease
NCT01430286Assistance Publique - Hôpitaux de Paris49
已完成
不适用
Improving Social Relationships for Adolescents With Central Disorders of HypersomnolenceNarcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia
NCT06251063Boston Children's Hospital25
已完成
不适用
BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern SwedenAnxiety DisorderObsessive-Compulsive Disorder
NCT02926365Karolinska Institutet83
已完成
不适用
The Development of a Psychoeducational Tool to Manage Anxiety in People With Autism Spectrum DisordersAutism Spectrum DisordersAnxiety
NCT02797379King's College London35
已完成
不适用
A web-based psycho-education intervention program for an adult community in Selangor, Malaysia
ISRCTN39656144niversiti Putra Malaysia (Malaysia)288