Trial document




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  DRKS00004320

Trial Description

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Title

Avoidance of treatment failures during inhalation therapie: medical instruction versus eductation by a video

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of the current study is to investigate if a video to explain the correct inhalation of different devices is as effective compared to an explanation by a medical doctor concerning mistakes in handling the medication.

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Brief Summary in Scientific Language

Patients with evidence of treatment failure in inhalation device wer identified. Patienst receive in a randomizied order either a medical instruction or education by a video. After 24h the treatment is reanalyzied and both interventions will be compared.

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Organizational Data

  •   DRKS00004320
  •   2012/09/12
  •   [---]*
  •   yes
  •   Approved
  •   2012031, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

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Health Condition or Problem studied

  •   J44.8 -  Other specified chronic obstructive pulmonary disease
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Interventions/Observational Groups

  •   education video about inhalation therapy
  •   medical instruction about inhalation therapy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Improvement in handling errors of inhalation therapie measured by a questionnaire. It is hypothesized that the education viedo is as effective compared to medical instruction avoidung handling errors after 24h.

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Secondary Outcome

In line to primary outcome a subanalysis will be performed regarding two differnt devices for inhaltaion: metered dose inhaler and dry powder inhaler.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/12/05
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

COPD-Patients on MDI (metered dose inhaler) or DPI (dry powder inhaler), who are admitted to the Cologne-Merheim Hospital, Kliniken der Stadt Köln gGmbH.

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Exclusion Criteria

Patients showing neurologic, congnitive or orthopedic problems leading to disfficulties in theh correct use of independent inhalation practise. Furthermor patients with no relevant failures of inhalation therapy (index < 2 points).

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Addresses

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    • Kliniken der Stadt Köln gGmbH Lungenklinik
    • Mr.  PD Dr. med.  Jan Hendrik  Storre 
    • Ostmerheimer Str. 200
    • D-51109  Köln
    • Germany
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    • Kliniken der Stadt Köln gGmbH Lungenklinik
    • Mr.  PD Dr. med.  Jan Hendrik  Storre 
    • Ostmerheimer Str. 200
    • D-51109  Köln
    • Germany
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    • Kliniken der Stadt Köln gGmbH Lungenklinik
    • Mr.  PD Dr. med.  Jan Hendrik  Storre 
    • Ostmerheimer Str. 200
    • D-51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Kliniken der Stadt Köln gGmbH Lungenklinik
    • Mr.  PD Dr. med.  Jan Hendrik  Storre 
    • Ostmerheimer Str. 200
    • D-51109  Köln
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • Deutsche Atemwegsliga
    • Im Prinzenpalais/Burgstraße
    • 33175  Bad Lippspringe
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/06/18
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Trial Publications, Results and other Documents

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