Trial document





This trial has been registered retrospectively.
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  DRKS00022946

Trial Description

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Title

Effects of digital therapy support using the smartphone application "Migräne-App" (migraine app)

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Trial Acronym

Migraine-App Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Tension type headache and migraine are - after dental caries - the second and third most prevalent diseases of mankind worldwide. The wide introduction of smartphones allows the use of specific software applications ("apps") for digital therapy support. The "Migräne-App” (migraine app) documents the course of migraine and headache with active data input. It reports back aggregated information from the data set and thereby helps both the patient as well as the treating physician in the verification of treatment success as well as in decisions about therapy adjustments. The migraine app contains reporting functions, an information section as well as self-help tools. In this study, the effects of using the "migraine app" in the practical treatment of migraine and headache patients are examined in a large cohort.

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Brief Summary in Scientific Language

Tension type headache and migraine are - after dental caries - the second and third most prevalent diseases of mankind worldwide. The wide introduction of smartphones allows the use of specific software applications ("apps") for digital therapy support. The "Migräne-App” (migraine app) documents the course of migraine and headache with active data input. It reports back aggregated information from the data set and thereby helps both the patient as well as the treating physician in the verification of treatment success as well as in decisions about therapy adjustments. The migraine app contains reporting functions, an information section as well as self-help tools. In this study, the effects of using the "migraine app" in the practical treatment of migraine and headache patients are examined in a large cohort.
An online survey will be developed for the analysis of experiences of the digital therapy support. It contains questions concerning socio-demographic variables, the course of headache disorders, and the previous treatment as well as usage patterns of the migraine app. The survey establishes compliance to a) the recommended therapy, b) the treatment plan, and c) the therapeutic rules devised by the treating physician. The data collected will compared to traditional pen-and-paper documentation, prior to using the migraine app.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The datasets generated during and/or analyzed during the current study are available on reasonable request.

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Organizational Data

  •   DRKS00022946
  •   2020/08/26
  •   [---]*
  •   yes
  •   Approved
  •   D491/18, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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

  •   G43 -  Migraine
  •   G44.2 -  Tension-type headache
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Interventions/Observational Groups

  •   Use of "Migräne-App" (migraine-app)
  •   Previous analog headache calendar
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Headache days per month. The end point will be recorded comparing the traditional pen-and-paper documentation prior to using the migraine app with the migraine app use at the time of conducting the survey.

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Secondary Outcome

Medication days per month. The end point will be recorded comparing the traditional pen-and-paper documentation prior to using the migraine app with the migraine app use at the time of conducting the survey.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/07/20
  •   1000
  •   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

G43
G44.2
Use of Migraine-App

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Exclusion Criteria

none

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Addresses

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    • Migräne- und Kopfschmerzstiftung gemeinnützige GmbH
    • Heikendorfer Weg 9-27
    • 24149  Kiel
    • Germany
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    • Schmerzklinik Kiel
    • Mr.  Prof. Dr. med. Dipl.-Psych.  Hartmut  Göbel 
    • Heikendorfer Weg 9-27
    • 24149  Kiel
    • Germany
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    • Schmerzklinik Kiel
    • Mr.  Prof. Dr. med. Dipl.-Psych.  Hartmut  Göbel 
    • Heikendorfer Weg 9-27
    • 24149  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Migräne- und Kopfschmerzstiftung gemeinnützige GmbH
    • Heikendorfer Weg 9-27
    • 24149  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/10/31
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Trial Publications, Results and other Documents

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