Trial document




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  DRKS00008880

Trial Description

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Title

Conception, implementation and feasibility of a study about the evaluation of a web-based post-rehabilitation support (website) for different medical indications – at first for patients with adiposity and/or diabetes type 2.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Conception, implementation and feasibility of a study about the evaluation of a web-based post-rehabilitation support (website) for patients with adiposity and/or diabetes type 2.
First of all, we undertake an analysis of the demands and needs. Afterwards we organize the conception and the creation of a coordinated web-based post-rehabilitation support platform. The platform shall be tested by the patients in a multistage process.

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Brief Summary in Scientific Language

Conception, implementation and feasibility of a study about the evaluation of a web-based post-rehabilitation support (website) for patients with adiposity and/or diabetes type 2.
First of all, we undertake an analysis of the demands and needs. Afterwards we organize the conception and the creation of a coordinated web-based post-rehabilitation support platform. The platform shall be tested by the patients in a multistage process.

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Organizational Data

  •   DRKS00008880
  •   2015/07/24
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  •   yes
  •   Approved
  •   2015-072-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   E66 -  Obesity
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Interviews with experts and patients about the demands and needs of assistance during a post-rehabilitation support. Patients are surveyed about needs of assistance during a post-rehabilitation support with the help of a questionnaire.
    Creation of the website.
    The website will be tested by patients subsequent to the end of their rehabilitation.
    Optimizing of the website. Afterwards start the Interventional part of the Study.
    Arm 1: A repeat test of the website by patients (intervention group: first enrollment planned 12.2015 ). At the end of the rehabilitation: definition of aims for the next 3 month. After 3 month patients are surveyed about how they achieved their aims after using the website.
  •   At the end of the rehabilitation: Definition of aims for the next 3 month. Control group: After 3 month, patients are surveyed about how they achieved their aims (without using the website).
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The post-rehabilitation support (website) is available and is prepared to be used by patients in Klinik Rosenberg with adiposity and/or diabetes type 2. In addition we compare how control group and intervention group achieved their aims after 3 month. The attainment of the aims is estimated by the patients using a scale with 10 stages.
In this pilot study we don´t anticipate a significant difference, but we want to estimate the expected effect of the intervention on the attainment of the aims. This is important to calculate the necessary number of cases of the evaluation study.

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Secondary Outcome

body weight after 3 months, HbA1c after 3 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/01/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Patients who completed a stationary rehabilitation in Klinik Rosenberg
• with main diagnosis adiposity or diabetes type 2
• with technical and cognitive requirements to use the internet
• who sign the declaration of agreement to participate in the study
• who have sufficient knowledge in the German language (in particular in writing)

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Exclusion Criteria

• status after bariatric surgery
• severe psychiatric disorder (e.g. at risk of suicide, severe eating disorder)
• severe somatic disease (cancer, status after LTX), that has a greater impact on the prediction of the patient than the metabolism disease

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Addresses

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    • Institut für Rehabilitationsforschung Norderney
    • Kaiserstraße 26
    • 26548  Norderney
    • Germany
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    • Klinik Rosenberg der DRV Westfalen
    • Mr.  Dr. med.  Harald  Fischer 
    • Hinter dem Rosenberge 1
    • 33014  Bad Driburg
    • Germany
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    • Klinik Rosenberg der DRV Westfalen
    • Mr.  Dr. med.  Harald  Fischer 
    • Hinter dem Rosenberge 1
    • 33014  Bad Driburg
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Rehabilitationsforschung Norderney
    • Kaiserstraße 26
    • 26548  Norderney
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.