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German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study. (GUR-HSQ)

Primary Purpose

Migraine, Tension-Type Headache

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Headache Screening Questionnaire
Sponsored by
Markus J. Ernst
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals who are older than 18 years, live in Switzerland speak and understand German have had multiple headache episodes of the same or similar type Exclusion Criteria: individuals with other known neurological conditions, known cognitive impairment known secondary headache types

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Kappe Value
    The HSQ uses nominal variables for screening the two primary headaches with defined cut-offs of 6 and 8 points for migraine and TTH, respectively. Therefore, for the test-retest reliability analysis, a Cohen's kappa with corresponding 95% confidence interval is calculated for both migraine and TTH.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2023
    Last Updated
    May 28, 2023
    Sponsor
    Markus J. Ernst
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05893004
    Brief Title
    German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.
    Acronym
    GUR-HSQ
    Official Title
    German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Markus J. Ernst

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this study is to learn more about the Headache Screening Questionnaire in people with Headache. The main question is: Does the lower limit of a 95% confidence interval of the HSQ in physiotherapy during a period of 2 to 4 weeks reach at least 0.4?
    Detailed Description
    Data are collected using the REDCap web application (https://redcap.zhaw.ch/). REDCap is designed for the creation and administration of online surveys. Respondents can access the survey directly via a QR code or link and complete the screening questionnaire via smartphone or computer. In a first step, the participating persons are included or excluded based on the criteria mentioned (chapter: Proband:innen). Once eligibility has been confirmed, the HSQ is completed online for the first time in a second step. After that, the test persons will receive a reminder e-mail after 2 weeks to complete the retest online. After the reminder email the test persons have 2 weeks to complete the retest. Those who participate later will be excluded and not included in the data analysis. In addition, the retest asks whether the headaches have changed compared to the test due to the physiotherapeutic treatment. This is asked with a three Likert scale (not changed, slightly changed, strongly changed). The severely changed headaches are not included in the analysis. Translated with www.DeepL.com/Translator (free version)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine, Tension-Type Headache

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    N/A
    Enrollment
    31 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Headache Screening Questionnaire
    Intervention Description
    The Dutch Headache Screening Questionnaire (HSQ) is the only screening questionnaire based on ICHD-3 which has at least moderate confidence in its criterion validity according to GRADE. The HSQ has already been translated into Portuguese and validated5. The HSQ has only 8 items and requires little time to complete. Due to its good sensitivity, the HSQ screening questionnaire is particularly well suited to exclude migraine.
    Primary Outcome Measure Information:
    Title
    Kappe Value
    Description
    The HSQ uses nominal variables for screening the two primary headaches with defined cut-offs of 6 and 8 points for migraine and TTH, respectively. Therefore, for the test-retest reliability analysis, a Cohen's kappa with corresponding 95% confidence interval is calculated for both migraine and TTH.
    Time Frame
    Participants are assessed based on criteria (chapter: participants). Eligible individuals complete the HSQ online. A reminder email is sent after 2 weeks for the retest. Participants have 2 weeks to complete it. Late participants are excluded from analys

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Individuals who are older than 18 years, live in Switzerland speak and understand German have had multiple headache episodes of the same or similar type Exclusion Criteria: individuals with other known neurological conditions, known cognitive impairment known secondary headache types
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ramon Gubser, Msc. student
    Phone
    076 360 40 55
    Email
    gubsera1@students.zhaw.ch
    First Name & Middle Initial & Last Name or Official Title & Degree
    Markus Wirz, Phd.
    Email
    erus@zhaw.ch

    12. IPD Sharing Statement

    Learn more about this trial

    German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.

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