Trial document




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  DRKS00005276

Trial Description

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Title

Extension and Evaluation of a Guidebook Application for Duchenne Muscular Dystrophy to empower affected Families

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Trial Acronym

[---]*

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URL of the Trial

http://portal.uni-freiburg.de/imbi/bereiche/medinf/projekte/dmdeval

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Brief Summary in Lay Language

Empowerment of patients and their relatives is becoming more and more important. In this, health information for lay people plays a crucial role. A growing number of these information services are provided as applications for mobile devices, especially for smartphones. The benefits of mobile applications have hardly been investigated systematically yet. It is assumed that health information applications entail diverse benefits. Hereby, the greater interactivity of the applications to other media may play a central role. This is especially applies with respect to empowerment, under the assumption that appropriate action mechanisms are trained by the active employment.

The aim of the project is to evaluate the effect of an application on the self-efficacy of Duchenne patients and their relatives. In addition, data on the distribution of the application, its usability and possible barriers for its usage will be collected.

To investigate the question, quantitative surveys and qualitative interviews will be conducted with stakeholders. Primary target is the increase of self-efficacy in Duchenne patients and their relatives after the intervention with the mobile guidebook application. In addition, data on the use of utility services, the usability and the use of individual functions are collected.

As intervention an application that contains the guide for families with Duchenne patients is used and extended by interactive functions (e.g. to document disease parameters or to remind of regular examinations). On the one hand, questionnaires with families of Duchenne patients that are registered in the register of Duchenne and Becker muscular dystrophies are conducted to collect data. On the other hand, qualitative interviews are scheduled with parents to gain information about their expectations and attitudes towards mobile applications.

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Brief Summary in Scientific Language

Background and significance: Personal responsibility and empowerment concepts are of increasing importance in healthcare. In this, health information for patients and their relatives plays a crucial role. A growing number of these information services are provided as applications for mobile devices, especially for smartphones. However, the benefits of mobile applications have hardly been evaluated systematically. It is believed that health information applications deliver diverse benefits. Hereby, the greater interactivity of mobile applications over other media may play a central role. This especially applies with respect to empowerment under the assumption that appropriate action mechanisms are trained by the active employment.

The aim of the study is to evaluate the effect of a mobile application on the self-efficacy of patients with Duchenne Muscular Dystrophy and their relatives. In addition, data on the distribution of the application in the target group, its usability and usage, as well as any barriers for family members and patients in the health care setting are collected.

To investigate these questions, a quasi-experimental intervention study with pre-test post-test design, and qualitative interviews will be conducted with stakeholders. Primary target is the increase of self-efficacy in Duchenne patients and their family memebers after the intervention with the mobile guide application. In addition, data on the use of utility services in the context of the application, the usability and the use of individual functions are collected.

As intervention a mobile application is used, that includes a guide for families with Duchenne patients, which is extended to provide interactive functions (such as documentation of disease parameters, or memory function for regular examinations).

On the one hand, questionnaire surveys with patients and their relatives are carried out to collect data, that are registered in the German-Austrian register for Duchenne Muscular Dystrophy and Becker. On the other hand, qualitative interviews will be conducted with parents of affected children to obtain information about the expectations and attitudes of the users towards mobile applications.

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Organizational Data

  •   DRKS00005276
  •   2013/09/20
  •   [---]*
  •   yes
  •   Approved
  •   362/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1147-9409 
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Health Condition or Problem studied

  •   G71.0 -  Muscular dystrophy
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Interventions/Observational Groups

  •   Intervention using the mobile application "DMD Guide" with registered Duchenne patients and their relatives owning an Android smartphone (supply of health information)
  •   Control Group: registered Duchenne patients and their relatives without Android smartphone (no usage of the app "DMD Guide")
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Pre-test post-test difference of the self-efficacy of patients and their relatives after intervention with the mobile guidebook application (questionnaire survey)

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Secondary Outcome

Use of utility services (such as physician inquiries about topics from the guidebook or the regularity of examinations)
Number of installations and usability (e.g. usage of the advanced features, appointments using the app)

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2013/11/11
  •   110
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Parents of patients with Duchenne Muscular Dystrophy from the German-Austrian patient registry (https://www.treat-nmd.de/register/)
Patients with Duchenne Muscular Dystrophy from the German-Austrian registry
Access to an internet-enabled device (PC, laptop, tablet, smartphone, etc.) to fill in the online questionnaires
For the second and third survey: a Android smartphone

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Exclusion Criteria

Respondent is not able to understand the German language sufficiently
Limitations of vision, so that no questionnaire can be read

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Addresses

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Sources of Monetary or Material Support

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    • Nachwuchsakademie Versorgungsforschung Baden-Württemberg, Abt. Allgemeinmedizin und Versorgungsforschung, Universitätsklinikum Heidelberg
    • Voßstraße 2
    • 69115  Heidelberg
    • Germany
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    •   [---]*
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    • Department für Medizinische Biometrie und Medizinische Informatik, Institut für Medizinische Biometrie und Statistik
    • Stefan-Meier-Straße 26
    • 79104  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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