Trial document




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  DRKS00019041

Trial Description

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Title

KardioApp - a mobile electronic application to improve self-management and increase adherence to therapy in patients with coronary heart disease (CHD)

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Trial Acronym

Kardio-App

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URL of the Trial

https://kardiopass.herzwegweiser.de

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Brief Summary in Lay Language

The KardioApp is intended to provide access to all medically relevant data of a cardiological patient and to provide more in-depth information and advice on how to perpetuate lifestyle changes.

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Brief Summary in Scientific Language

Research question: The question is investigated to what extent the mobile electronic application (app) is accepted and used by the target group. Furthermore, it has to be quantified how strong the need for this app is and how often it is used.
Hypotheses: The cardiological mobile application (cardio app) is accepted and heavily used by the target group. In addition to simplifying treatment and care processes, the app leads to regular participation of patients in recommended medical follow-up examinations (e.g. 1-2 visits per year to a cardiologist) and in aftercare offers (e.g. cardiac groups, tobacco cessation measures), in addition to the independent documentation of behavior-related and physiological risk and protection parameters.

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Organizational Data

  •   DRKS00019041
  •   2019/11/12
  •   [---]*
  •   yes
  •   Approved
  •   EA4/028/19, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   I25 -  Chronic ischaemic heart disease
  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   Patients with cardiovascular diseases receive access to the KardioApp and evaluate it after a period of use of five months.
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Characteristics

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

Quantitative user survey, acceptance analysis. The survey take place five months after the KardioApp has been used for the first time.

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2019/11/15
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Patients with coronary heart disease or heart failure.

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Exclusion Criteria

Patients who are cognitively or linguistically severely restricted, seriously ill, or younger than 18 years of age or older than 81 years of age and have insufficient knowledge of the German language.

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Addresses

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    • Deutsche Rentenversicherung Berlin-Brandenburg
    • Knobelsdorffstraße 92
    • 14059  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Charité - Universitätsmedizin Berlin, Institut für Medizinische Soziologie und Rehabilitationswissenschaft
    • Ms.  Dr. med.  Sabine  Stamm-Balderjahn 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Institut für Medizinische Soziologie und Rehabilitationswissenschaft
    • Ms.  Dr. med.  Sabine  Stamm-Balderjahn 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Berlin-Brandenburg
    • Knobelsdorffstraße 92
    • 14059  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.