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Two Narrative Medicine Interventions in Type 1 Diabetes

2017年12月1日 更新者:Agnes Hartemann、Assistance Publique - Hôpitaux de Paris

Comparison Between Two Narrative Medicine Approaches in Type 1 Diabetes (T1D): a Prospective Randomized Study

a randomized prospective study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (Problem Areas in Diabetes Questionnaire PAID) and illness perception ( Illness Perception Questionnaire IPQR) during a 5 day education course

研究概览

详细说明

This randomized prospective pilot study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (Problem Areas in Diabetes Questionnaire PAID) and illness perception ( Illness Perception Questionnaire IPQR) during a 5 day education course on Functional Insulin Therapy (FIT). Questionaries at T0 (course day 1 ) and T1 (3 months later). qualitative interviews in a sub group of patients random G1 and G2 subgroup at T1, with a general inductive approach to capture all representations

研究类型

介入性

注册 (实际的)

87

阶段

  • 不适用

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

16年 及以上 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • type 1 diabetes

Exclusion Criteria:

  • no french language

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:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:living theatre
One session consisting for the patient of telling a story about his/her own life with diabetes , which is first written and then transformed to a script to be played by professional actors co-directed by the patient with the support of the Director to create a little play.
participating to a session of "living theatre" which consists in writing a story about life with diabetes, which is then transformed to a script to be played by professional actors co-directed by the patient with the support of the Director to create a short play
有源比较器:writing workshop
one session consisting for the patient of writing a "Letter to his/her own diabetes" and then to read it to the group of patients and the healthcare providers.
one session consisting for the patient of writing a "Letter to his/her own diabetes" and then to read it to the group of patients and the healthcare providers.

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
Change from baseline IPQR (Illness Perception Questionnaire) score at 3 months
大体时间:3 months after intervention
Illness Perception Questionnaire (IPQR) There is no total score for IPQR Nine subscales are reported for IPQR. High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition. High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition. Minimal and maximal score are respectively 0 and 14 for identity, 0 and 30 for timeline, consequences, personal control, and emotional representations, 0 and 25 for treatment control and illness coherence illness, 0-20 for timeline cyclical
3 months after intervention

次要结果测量

结果测量
措施说明
大体时间
comparison of the two groups concerning answers to qualitative interviews at T 3 months after the intervention
大体时间:3 months after intervention
A psychologist conducted qualitative interviews according to a blinded process in a subgroup of 6 patients at T3 months, with a general inductive approach to capture all representations on diabetes and the session. Transcribed Interviews were analyzed regarding inductive coding and 2 independent investigators built and tested a coding schedule.
3 months after intervention

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。

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

2012年2月1日

初级完成 (实际的)

2013年2月28日

研究完成 (实际的)

2013年8月1日

研究注册日期

首次提交

2017年11月17日

首先提交符合 QC 标准的

2017年12月1日

首次发布 (实际的)

2017年12月7日

研究记录更新

最后更新发布 (实际的)

2017年12月7日

上次提交的符合 QC 标准的更新

2017年12月1日

最后验证

2017年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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