- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04877561
Test-Retest Reliability of the German Version of the Headache Disability Questionnaire (HDQ).
May 7, 2021 updated by: Markus J. Ernst, Zurich University of Applied Sciences
Translation, Trans-cultural Adaptations and Test-retest Reliability of the Headache Disability Questionnaire (HDQ)
a translated and cultural adapted version of the HDQ will be tested on two occasions with headache patients who are currently in physiotherapeutic treatment due to their headache condition
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
The test-retest reliability of the German version of the HDQ will be tested to assess the reproducibility of the test results with a stable condition of the participants over a short period of time.
For this purpose, it is planned to administer the questionnaire twice in row at an interval of 48 - 72 hours to headache patients in outpatient physiotherapy.
The chosen setting limits the sample to a common intervention measure (physiotherapy), so that primary and secondary headache types can be included and the requirements of the original study can be maintained.
In the period between the two tests, subjects should not receive physiotherapy, because it can often have different effects on headache.
This can lead to uneven changes in the sample and affect the variance of the test results.
However, subjects are allowed to take their usual medications.
To avoid recall bias, an online survey tool (RedCAP) to conduct the questionnaire will be used.
It is designed so that, only one question appears per slide, no overview of responses is allowed and the questions are displayed in a different order at the second testing.
The lower prevalence of headaches after the age of 65 years is taken into account in the inclusion criteria.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Markus J Ernst, Master
- Phone Number: +41 58 9346448
- Email: markus.ernst@zhaw.ch
Study Contact Backup
- Name: Dimo Ivanov, BSc
- Email: ivanodim@students.zhaw.ch
Study Locations
-
-
Zurich
-
Winterthur, Zurich, Switzerland, 8400
- Zurich University of Applied Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects suffering from a headache condition and are due to that in physiotherapeutic care
Description
Inclusion Criteria:
- within physiotherapeutic care due to headache for no longer than 3 months
- headache conditions for at least one month and at least once /month
- live in Switzerland
- give informed consent
Exclusion Criteria:
- not in physiotherapeutic care
- in physiotherapeutic care due to other conditions not associated with headache
- younger than 18 and older than 65 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache
Time Frame: June 21 to July 22
|
Nine item headache disability questionnaire (HDQ)
|
June 21 to July 22
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache disorder
Time Frame: June 21 to July 22
|
Migraine, Tension-type headache, other
|
June 21 to July 22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Markus J Ernst, Master, Zurich University of Applied Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Luedtke K, Basener A, Bedei S, Castien R, Chaibi A, Falla D, Fernandez-de-Las-Penas C, Gustafsson M, Hall T, Jull G, Kropp P, Madsen BK, Schaefer B, Seng E, Steen C, Tuchin P, von Piekartz H, Wollesen B. Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study. BMJ Open. 2020 Feb 12;10(2):e029855. doi: 10.1136/bmjopen-2019-029855.
- Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.
- Niere K, Quin A. Development of a headache-specific disability questionnaire for patients attending physiotherapy. Man Ther. 2009 Feb;14(1):45-51. doi: 10.1016/j.math.2007.09.006. Epub 2007 Nov 7.
- Benz T, Lehmann S, Gantenbein AR, Sandor PS, Stewart WF, Elfering A, Aeschlimann AG, Angst F. Translation, cross-cultural adaptation and reliability of the German version of the migraine disability assessment (MIDAS) questionnaire. Health Qual Life Outcomes. 2018 Mar 9;16(1):42. doi: 10.1186/s12955-018-0871-5.
- Marx RG, Menezes A, Horovitz L, Jones EC, Warren RF. A comparison of two time intervals for test-retest reliability of health status instruments. J Clin Epidemiol. 2003 Aug;56(8):730-5. doi: 10.1016/s0895-4356(03)00084-2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
July 31, 2022
Study Completion (Anticipated)
September 30, 2022
Study Registration Dates
First Submitted
May 3, 2021
First Submitted That Met QC Criteria
May 3, 2021
First Posted (Actual)
May 7, 2021
Study Record Updates
Last Update Posted (Actual)
May 12, 2021
Last Update Submitted That Met QC Criteria
May 7, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZUAS HDQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no intention to share the IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Headache Disorders
-
Canadian Memorial Chiropractic CollegeDr. Zaxx Co.UnknownMigraine Headache | Cervicogenic Headache | Tension-type HeadacheCanada
-
University GhentRecruitingTension-Type Headache | Cervicogenic Headache | Myofascial HeadacheBelgium
-
Real Centro Universitario Maria CristinaRecruiting
-
Brooke Army Medical CenterThe University of Queensland; The Defense and Veterans Brain Injury CenterRecruitingHeadache, Migraine | Persistent Post Traumatic Headache | Cervicogenic HeadacheUnited States
-
University Hospital, GhentRecruitingMigraine Disorders | Headache Disorders | Tension-Type Headache | Cluster Headache | TACS | Secondary Headache DisorderBelgium
-
Wei DaiInternational Headache SocietyRecruitingMigraine Disorders | Medication-overuse HeadacheChina
-
Hospital of South West JutlandCompletedMedication-overuse Headache | Secondary Headache Disorders
-
University of AlbertaCompletedChronic Headache | Chronic Daily Headache | Analgesic Rebound Headache | Headache, IntractableCanada
-
Bnai Zion Medical CenterUnknownChildren, Only | Headache, Migraine | Headache, TensionIsrael
-
University of WashingtonTerminatedChronic Post Traumatic HeadacheUnited States