Trial document




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  DRKS00015614

Trial Description

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Title

Feasibility study: Checking the functionality, practicality and acceptance of the app SELFPASS

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Trial Acronym

Feasibility study SELFPASS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The SELFPASS project is developing an app for patients with depression waiting for a treatment. In this application, users are asked about their mood every day, and then the program suggests an intervention to help them self-manage their disease. SELFPASS is programmed for the smartphone, a tablet or a conventional PC. The aim of this study is to check the feasibility of the application.

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Brief Summary in Scientific Language

The present study is a feasibility study with the aim of examining the app SELFPASS (self-management for patients with depression: Self-administered Psycho Therapy SystemS) developed in the BMBF funding project in terms of functionality, suitability for daily use and acceptance. This application is designed to improve the self-management of patients with depression. These are to test the application with regard to technical quality criteria in the context of the study.

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Organizational Data

  •   DRKS00015614
  •   2018/09/18
  •   [---]*
  •   yes
  •   Approved
  •   S-296/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34 -  Persistent mood [affective] disorders
  •   F38 -  Other mood [affective] disorders
  •   F39 -  Unspecified mood [affective] disorder
  •   Z73 -  Problems related to life-management difficulty
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Interventions/Observational Groups

  •   Subjects have the option to test SELFPASS either on their own mobile device or on a PC before starting the study, or they will receive a loan unit. After an introduction to the goal and the schedule of the study, the subjects receive a questionnaire (day 0), which must be completed. All further questionnaires (day 1-5) are already issued. The program SELFPASS can be opened via a browser. Subjects will be asked to self-assess every day for 5 days about their mood and play through at least one of the interventions. Afterwards an evaluation sheet will be completed.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The feasibility of the app SELFPASS is examined on the basis of these criteria:
• Functionality and quality of data acquisition: Are the functions of the app programmed correctly and lead to traceable results, intervention suggestions and history information?
• Everyday suitability: Can the app be integrated into everyday life or are obstacles seen with regard to time and effectiveness?
• Acceptance: Is the app accepted positively, or are there any fundamental concerns, for example regarding privacy, security, etc.? User acceptance refers to the nature of the subject's involvement with SELFPASS. This means examining the relationship between positive acceptance and rejection of the system.
The main objective criteria are checked against the results of self-developed and standardized questionnaires.

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Secondary Outcome

The secondary objective is the improvement of current developments in the BMBF funding project SELFPASS. The aim is to receive concrete suggestions for improvement from the subjects who can still flow into the implementation. These collateral targets are checked against some items in the questionnaires and further qualitative comments.
Another secondary objective criterion is the investigation of technology trust, attitudes to information systems and the usability of the system.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/02/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

The study will include max. 40 patients included, who are adult, have sufficient German language skills and have received a diagnosis from the field of depressive symptoms. These may or may not be patients at Heidelberg University Hospital and have one of the following diagnoses: mild to moderate depressive episode (F32.0 or F32.1), recurrent depression (F33), or other affective disorder (F38); Reactions to severe stress and adjustment disorders (F43); Problems related to difficulties in coping with life (Z73).
All subjects who agree to participate in the study receive the respective information document and the declaration of consent, which are explained in detail. In this way, the consent of all subjects is guaranteed (informed consent).

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Exclusion Criteria

The main exclusion criterion is the lack of consent. All subjects can also be excluded from the study at their own request. All patients may also withdraw from the study retroactively.
Other exclusion criteria include a major depressive episode (F32.2) and suicidality.

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Allgemeine Innere Medizin und Psychosomatik (Innere II)
    • Mr.  PD Dr.  Jobst-Hendrik  Schultz 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Allgemeine Innere Medizin und Psychosomatik (Innere II)
    • Ms.  Dipl.-Psych.  Gwendolyn  Mayer 
    • Im Neuenheimer Feld 130.3
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF) - Referat Gesundheitsforschung
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/31
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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.