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Transition Preparation Intervention for Young Adults With Type 1 Diabetes

2020年11月5日 更新者：Virginia Commonwealth University

Implementing a Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting

The purpose of this research study is to find out more about how to support young adults (ages 18-22) with type 1 diabetes as they prepare to transition from pediatric and adult endocrinology medical care.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The overarching goal of the proposed trial is to improve diabetes self-management and glycemic control in young adults and prepare them for the transition to adult endocrinology. The current application will investigate the impact of a multisystem transition preparation intervention for young adults (ages 18-22) with T1D. Twenty-five young adults and a parent will be enrolled in a 6-month transition preparation program which will use a hybrid in-person and technology delivery structure. Providers will receive training highlighting their role preparing young adults for transition and provides practical tips to use in their communication with young adults. If effective, this multisystem intervention, designed to enhance T1D self-management and increase young adults' readiness for transition to adult healthcare during this critical developmental period, has the potential to inform clinical practice guidelines.

研究类型

介入性

注册 (实际的)

62

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Virginia
      • Richmond、Virginia、美国、23298
        • Children's Hospital of Richmond at Virginia Commonwealth University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Both members of the youth/parent dyad must meet all eligibility criteria

Young adults

  • English-speaking
  • patients in Pediatric Endocrinology at Children's Hospital of Richmond (CHoR) at Virginia Commonwealth University (VCU)
  • between ages 18-22 yrs with a
  • diagnosis of T1D for >1 year

Parents

  • greater than 18 years of age
  • provide care to the young adult with T1D
  • are willing to participate in the intervention

Medical providers

• provide care to patients with T1D ages 18-22 yrs in Pediatric Endocrinology at CHoR

Exclusion Criteria:

Young adults

  • significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability), as documented in the medical record or revealed during eligibility screening, or
  • medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes

Parents

  • non-English speaking
  • psychiatric, cognitive, or developmental conditions that would impair their ability to complete assessments and/or engage in the intervention as determined at study screening

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Transition preparation program
Transition preparation intervention for young adults with type 1 diabetes (T1D)
行为的：Transition preparation intervention
Young adult participants and parents will complete transition preparation sessions that include meeting with a health behavior coach for in-person sessions and review of materials sent electronically between study visits.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of sessions attended
大体时间：6 months
Number of study visits (attendance)
6 months
Number of session views
大体时间：6 months
Number of opened electronic materials (e.g., opened messages in the patient health portal))
6 months
Program acceptability - young adult
大体时间：9 months
Young adult report on satisfaction with the program via an exit survey
9 months
Program acceptability - parent
大体时间：9 months
Parent report on satisfaction with the program via an exit survey
9 months
Program acceptability - provider
大体时间：9 months
Provider report on satisfaction with the program via an exit survey
9 months

次要结果测量

结果测量
措施说明
大体时间
Change in Glycemic control
大体时间：Baseline to 9 months
Measurement of hemoglobin A1c (A1c; reported as a percentage)
Baseline to 9 months
Diabetes-related hospitalizations
大体时间：9 months
Participant report and medical record review of count of reported diabetes-related hospitalizations and complications
9 months
Change in adherence to diabetes care regimen
大体时间：Baseline to 9 months
Average of young adult and parent participant reports on the Diabetes Management Questionnaire (DMQ)
Baseline to 9 months
Change in transition readiness
大体时间：Baseline to 9 months
Average of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ)
Baseline to 9 months

其他结果措施

结果测量
措施说明
大体时间
Change in diabetes self-efficacy
大体时间：Baseline to 9 months
Participant (young adult) report on the Self-Efficacy for Diabetes Self-Management (SEDSM)
Baseline to 9 months
Change in diabetes quality of life
大体时间：Baseline to 9 months
Participant (young adult) report on the Pediatric Quality of Life Diabetes Module
Baseline to 9 months
Change in diabetes family responsibility
大体时间：Baseline to 9 months
Average of young adult and parent participant reports on the Diabetes Family Responsibility Questionnaire (DFRQ)
Baseline to 9 months
Change in diabetes family conflict
大体时间：Baseline to 9 months
Average of young adult and parent participant reports on the Diabetes Family Conflict Scale (DFCS)
Baseline to 9 months
Change in depression
大体时间：Baseline to 9 months
Participant (young adult) report on the Center for Epidemiologic Studies Depression Scale (CESD)
Baseline to 9 months
Change in young adult diabetes distress
大体时间：Baseline to 9 months
Participant (young adult) report on the Diabetes Distress Scale
Baseline to 9 months
Change in parent diabetes distress
大体时间：Baseline to 9 months
Participant (parent) report on the Diabetes Distress Scale for Parents of Teens with T1D
Baseline to 9 months
Change in autonomy support
大体时间：Baseline to 9 months
Participant (young adult) report on the autonomy support sub-scale of the Barriers to Diabetes Adherence Questionnaire
Baseline to 9 months
Change in problem solving
大体时间：Baseline to 9 months
Participant (young adult) report on the Diabetes Adherence Problem Solving Questionnaire
Baseline to 9 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Virginia Commonwealth University

合作者

American Diabetes Association

调查人员

  • 首席研究员：Laura Caccavale, PhD、Virginia Commonwealth University
  • 首席研究员：Melanie Melanie, PhD、Virginia Commonwealth University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年7月11日

初级完成 (实际的)

2020年9月16日

研究完成 (实际的)

2020年9月16日

研究注册日期

首次提交

2019年6月24日

首先提交符合 QC 标准的

2019年6月24日

首次发布 (实际的)

2019年6月26日

研究记录更新

最后更新发布 (实际的)

2020年11月9日

上次提交的符合 QC 标准的更新

2020年11月5日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HM20015399
  • 1-19-PDF-041-R (其他赠款/资助编号：American Diabetes Association)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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