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Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT) (INPUT)

2017年11月24日 更新者：Norbert Hermanns

Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy

This study is a randomized, controlled, prospective trial with a 6-month follow-up. A newly developed treatment and education programme for diabetic patients with an insulin pump therapy (INPUT) will be tested compared to a waiting group. Primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome variables are: severe hypoglycaemia, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes empowerment, self-care behavior, hypoglycemia awareness, and attitudes towards insulin pump therapy.

研究概览

地位

完全的

条件

干预/治疗

详细说明

INPUT is a self-management-based treatment and education program for diabetic patients with an insulin pump (CSII). It is designed to empower patients to adequately perform their therapy in daily life and to integrate their diabetes and their insulin pump into their lifes in order to enhance quality of life.

INPUT ist tested in an randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for CSII exists.

This study is a multi-center study. Study centers are specialized diabetes practices throughout Germany. Patients will be approached by their respective practice and informed about the study. Study measurements as well as the conduct of INPUT will take place at the respective practice.

Baseline measurement will take place 2 weeks prior to the beginning of INPUT. After completion of baseline measurement, all patients from one study center will be randomized centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and 6 months after the completion of INPUT, follow-up measurements will be conducted at the respective study center.

HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Secondary outcome measures will be assessed via psychometrically tested questionnaires, Case Reports Forms, or patient files.

研究类型

介入性

注册 (实际的)

268

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

  • 德国
      • Neuss、德国、41462
        • Diabetologische Schwerpunktpraxis Neuss

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 至 75年 (孩子、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:

  • Existing insulin pump therapy
  • Prior participation in a structured diabetes education program
  • HbA1c ≥ 7,5% but ≤ 13%
  • Ability to understand, speak and write German language
  • informed consent (if necessary, informed consent of the parents)

Exclusion Criteria:

  • Diabetes duration < 1 year
  • severe organic disease preventing a regular participation in the training course
  • pregnancy
  • severe cognitive impairment
  • current treatment of psychiatric disorder
  • renal disease requiring dialysis

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：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 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：INPUT
INPUT consists of 12 lessons comprising all relevant information in order to treat diabetes with an insulin pump. Patients learn to effectively use the different features of their pump in order to improve not only glycemic control but also to improve the implementation of pump therapy in daily life. Psychological and motivational aspects of living with diabetes and living with an insulin pump are addressed as well.
行为的：INPUT

Treatment and education program based on the self-management theory of behavioral medicine.

The program is delivered by certified and specially trained diabetes educators.

其他名称：
  • treatment and education program for INsulin PUmp Therapy
无干预：Waiting list
Patients are randomly assigned to the waiting list. After completion of the 6-month follow-up, these patients will also receive training with INPUT.

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
Changes in Glycemic Control Measured by A1c
大体时间：6 months
Difference between baseline A1c and A1c at the 6-month follow-up
6 months

次要结果测量

结果测量
措施说明
大体时间
Hypoglycaemia Awareness
大体时间：6 months
The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.
6 months
Diabetes Empowerment
大体时间：6 months
Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
6 months
Problem Areas in Diabetes
大体时间：6 months
The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
6 months
Satisfaction with current treatment
大体时间：6 months
Satisfaction with current treatment is assessed via a 10-item scale. The total score ranges from 10 to 60 with lower scores indicating higher satisfaction.
6 months
Diabetes Self-Management
大体时间：6 months
The Diabetes Self-Management Questionnaire is a self-report measure of patients' self-care. The level of self-care is assessed via Likert scales.
6 months
Diabetes Distress
大体时间：6 months
The Diabetes Distress Scale (DDS) assesses diabetes-related stressors due to living and treating diabetes. Different aspects of distress are covered: emotional burden, physician-related, regimen-related, diabetes-related interpersonal
6 months
Health-related Quality of Life
大体时间：6 months
Health-related quality of life focuses on the health-specific aspects of quality of life and dealing with a chronic condition such as diabetes
6 months
Depressive symptoms
大体时间：6 months
The presence and extent of typical depressive symptoms are assessed via self-report
6 months
Attitudes towards insulin pump therapy
大体时间：6 months
Specific attitudes towards different aspects of insulin pump therapy are assessed via Likert scales. The questionnaire consists of 6 subscales that can be placed within 4 dimensions: (I) Expectations on insulin pump therapy (subscale: achieving better glycaemic control) (II) Perceived advantages of an insulin pump (subscale: gaining more flexibility) (III) Ease of use (subscales: design + functionality) (IV) Psychosocial effects and barriers (subscales: technological dependence + impaired body image)
6 months
Severe hypoglycaemia
大体时间：6 months
The incidence of severe hypoglycaemia in the past six months is assessed via Case Report Forms. Severe hypoglycaemia is defined as requiring third party assistance or medical intervention for treating hypoglycaemia.
6 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

Norbert Hermanns

合作者

Berlin-Chemie

调查人员

  • 首席研究员：Norbert Hermanns, PhD、Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2016年4月1日

初级完成 (实际的)

2017年2月1日

研究完成 (实际的)

2017年3月1日

研究注册日期

首次提交

2016年4月20日

首先提交符合 QC 标准的

2016年8月11日

首次发布 (估计)

2016年8月16日

研究记录更新

最后更新发布 (实际的)

2017年11月28日

上次提交的符合 QC 标准的更新

2017年11月24日

最后验证

2017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

  • NH012016

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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