Trial document




drksid header

  DRKS00011777

Trial Description

start of 1:1-Block title

Title

International consensus for a measuring instrument for the collection of headaches in patients with chronic or high-frequency episodic migraine in non-pharmacological studies: A Delphi study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The planned Delphi Survey is to be carried out according to the recommendations of Hasson et al. (2000) and following the work of Lüdtke et al. (2016). For this purpose, suitable measuring instruments for non-pharmaceutical studies are identified in the first step by means of systematic literature research. The second step is to assess, in the form of a Delphi survey, existing measuring instruments from non-pharmacological studies of twenty experts from headache research and five affected migraine patients. The aim of the study is to obtain an international consensus for one or more measuring instruments for the assessment of headache symptoms in patients with chronic migraine in non-pharmacological studies, as well as a realistic cut-off value, using a Delphi survey which is considered to be clinically relevant for this instruments.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011777
  •   2017/05/09
  •   [---]*
  •   yes
  •   Approved
  •   2017_89, Lokale Ethikkommission der Fakultät für Psychologie und Bewegungswissenschaften der Universität Hamburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G43 -  Migraine
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   It is a Delphi study. In the first questionnaire, 20 experts in headache research (authors who have conducted and published studies on non-pharmacological interventions in migraine patients) will be asked how to assess the clinical instruments identified by systematic literature research regarding their clinical usefulness on a 5-point Likert- Scale. In addition, they are asked whether they have their own proposals for clinically relevant measuring instruments. The answers are analyzed from each questionnaire quantitatively and summarized in a table. In the second questionnaire, the experts will be presented the analyzed answers from the first round and added the newly proposed measuring instruments. The experts are again asked to evaluate the measuring instruments for their clinical usefulness. In the third round, all new information from the second round will be included and presented to the experts.
  •   It is a Delphi study. Five patients with chronic migraine will be interviewed about the clinical usefulness of the identified measuring instruments.
    There will be three questionnaires of the Delphi study similar to the experts. For the patients the questionnaires are written in form of information understandable and comprehensible to the layperson.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Achieve an international consensus for one or more measuring instrument (s) to collect changes in headache symptoms in patients with chronic migraine in non-pharmacological studies and determine a realistic cut-off value that is clinically relevant for this instrument (s).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   United States
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/05/12
  •   25
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Authors who have conducted studies on non-pharmacological interventions in migraine patients
- Affected patients with the diagnosis of a chronic migraine
- Minimum age 18 years

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

[---]*

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Hamburg / Fakultät für Psychologie und Bewegungswissenschaft
    • Ms.  Dr.  Kerstin  Lüdtke 
    • Mollerstraße 10/ Postanschrift Turmweg 2
    • 20148  Hamburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universität Hamburg / Fakultät für Psychologie und Bewegungswissenschaft
    • Ms.  Dr.  Kerstin  Lüdtke 
    • Mollerstraße 10/ Postanschrift Turmweg 2
    • 20148  Hamburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universität Hamburg / Fakultät für Psychologie und Bewegungswissenschaft
    • Ms.  Dr.  Kerstin  Lüdtke 
    • Mollerstraße 10/ Postanschrift Turmweg 2
    • 20148  Hamburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universität Hamburg / Fakultät für Psychologie und Bewegungswissenschaft
    • Ms.  Dr.  Kerstin  Lüdtke 
    • Mollerstraße 10/ Postanschrift Turmweg 2
    • 20148  Hamburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Enrolling by invitation
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.