Trial document





This trial has been registered retrospectively.
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  DRKS00003767

Trial Description

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Title

Demonstration Project acupuncture (for asthma), by the Technicians' Health Insurance Company and other participating health insurance companies - Health economics

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Trial Acronym

ARC-Asthma

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URL of the Trial

http://-

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Brief Summary in Lay Language

Purpose of this study was to determine whether the reimbursement of acupuncture is a sensible use of scarce resources of the statutory health insurance. For this purpose, one patient group received an acupuncture treatment, another group received no specific therapy. Costs and quality of life was recorded during the study and compared between groups. The healthy economic analysis was part of the Project acupuncture by the Technicians Health Insurance Company and other participating health insurance companies (see also DRKS00009621).

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Brief Summary in Scientific Language

The aim of this study was to assess economic aspects of additional acupuncture treatment in patients with allergic bronchial asthma compared to patients receiving routine care alone. Therefore, in a randomized controlled trial, patients with allergic bronchial asthma were either allocated to a group receiving acupuncture immediately or a waiting list control group. Both groups were free to use routine care treatment. The resource consumption, costs and health related quality of life was evaluated at baseline and 3 months after by using statutory health insurance information and standardized questionnaires. Main economic outcome parameters were direct and indirect cost differences during the study period and the incremental cost effectiveness ratio (ICER) of acupuncture treatment.
The healthy economic analysis was part of the Project acupuncture by the Technicians Health Insurance Company and other participating health insurance companies (see also DRKS00009621).

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Organizational Data

  •   DRKS00003767
  •   2012/04/27
  •   [---]*
  •   no
  •   Approved
  •   1424/2000, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   DRKS00009621  (Registrierungsnummer des Hauptprojekts)
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Health Condition or Problem studied

  •   J45 -  Asthma
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Interventions/Observational Groups

  •   Acupuncture immediately (between 10 and a maximum of 15 single-sessions within 3 months intervention period, The intervals between treatments were individually)
  •   Waiting group (waiting time: 3 months)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Health economics
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Cost per QALY gained (quality adjusted life year) after 3 months

Procedure: The measurement of quality of life was performed using the SF36-questionnaire at baseline and after 3 months. Conversion into QALYs was performed using Algorithms by Brazier et al. (. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36 J Health Econ 2002 21 (2) :271-292.)

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Secondary Outcome

costs per group

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2000/12/22
  •   892
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients with allergic bronchial asthma were included. Allergic bronchial asthma was defined as an inflammatory disease of the airways with bronchial hyperreactivity and variable airway obstruction, often associated with an atopic predisposition. The diagnosis must made by a physician.

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Exclusion Criteria

The suspicion of bronchial asthma with non-allergic origin was an exclusion criterion. Other obstructive airway diseases or expiratory dyspnea were also excluded.

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Addresses

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    • Institut f. Sozialmedizin, Epidemiologie & Gesundheitsökonomie - Charité Universitätsmedizin Berlin
    • Mr.  Prof.  Stefan N.  Willich 
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
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    • Institut für Sozialmedizin, Epidemiologie & Gesundheitsökonomie - Charité Universitätsmedizin Berlin
    • Mr.  Dr.  Thomas  Reinhold 
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
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    • Institut für Sozialmedizin, Epidemiologie & Gesundheitsökonomie - Charité Universitätsmedizin Berlin
    • Ms.  Beatrice  Eden 
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Techniker Krankenkasse Hamburg
    • Bramfelder Str. 138
    • 22305  Hamburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2002/12/15
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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.