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
About this trial
This is an interventional diagnostic trial for Migraine
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
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
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.
We'll reach out to this number within 24 hrs