Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT04877561
Status:
UNKNOWN
Last Update Posted:
2021-05-12
First Post:
2021-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Test-Retest Reliability of the German Version of the Headache Disability Questionnaire (HDQ).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-02', 'releaseDate': '2025-08-13'}], 'estimatedResultsFirstSubmitDate': '2025-08-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020773', 'term': 'Headache Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache', 'timeFrame': 'June 21 to July 22', 'description': 'Nine item headache disability questionnaire (HDQ)'}], 'secondaryOutcomes': [{'measure': 'Headache disorder', 'timeFrame': 'June 21 to July 22', 'description': 'Migraine, Tension-type headache, other'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache Disorders']}, 'referencesModule': {'references': [{'pmid': '17997346', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20473702', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32051295', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29523138', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12954464', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects suffering from a headache condition and are due to that in physiotherapeutic care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* within physiotherapeutic care due to headache for no longer than 3 months\n* headache conditions for at least one month and at least once /month\n* live in Switzerland\n* give informed consent\n\nExclusion Criteria:\n\n* not in physiotherapeutic care\n* in physiotherapeutic care due to other conditions not associated with headache\n* younger than 18 and older than 65 years'}, 'identificationModule': {'nctId': 'NCT04877561', 'briefTitle': 'Test-Retest Reliability of the German Version of the Headache Disability Questionnaire (HDQ).', 'organization': {'class': 'OTHER', 'fullName': 'Zurich University of Applied Sciences'}, 'officialTitle': 'Translation, Trans-cultural Adaptations and Test-retest Reliability of the Headache Disability Questionnaire (HDQ)', 'orgStudyIdInfo': {'id': 'ZUAS HDQ'}}, 'contactsLocationsModule': {'locations': [{'zip': '8400', 'city': 'Winterthur', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Zurich University of Applied Sciences', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}], 'centralContacts': [{'name': 'Markus J Ernst, Master', 'role': 'CONTACT', 'email': 'markus.ernst@zhaw.ch', 'phone': '+41 58 9346448'}, {'name': 'Dimo Ivanov, BSc', 'role': 'CONTACT', 'email': 'ivanodim@students.zhaw.ch'}], 'overallOfficials': [{'name': 'Markus J Ernst, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zurich University of Applied Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no intention to share the IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zurich University of Applied Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research fellow, MSc,', 'investigatorFullName': 'Markus J. Ernst', 'investigatorAffiliation': 'Zurich University of Applied Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-13', 'type': 'RELEASE'}, {'date': '2025-09-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Markus J. Ernst, Research fellow, MSc,, Zurich University of Applied Sciences'}}}}