Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2022-11-01
2025-12-31
Brief Summary
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Detailed Description
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To gain a better understanding of the emotional and functional effects of headaches on the patient's well-being, an English questionnaire already exists: the Henry Ford Headache Disability Index (HDI). The purpose of the HDI is to map headache related disabiltiy. This 25-item questionnaire focusses on two categories; there are 13 questions in the field of emotional effects and 12 questions on functional effects of headache complaints.
Advantage: This questionnaire can be used for all headache patients, in contrast to many questionnaires that can only be used for migraine patients. (eg MIDAS, Migraine ACT, ID Migraine...) The questionnaire contains more items than the Headache Impact Test (HIT-6), consisting of 6 items. The questions are very specifically aimed at headaches and can also be used to further inquire about the anamnesis after completing the questionnaire.
Problem statement: There is no validated Dutch version yet.
Objective: to translate and validate a Dutch version of the HDI. About 250 patients with chronic headache will be recruited to determine the validity (face validity, content validity, convergent validity with the RAND-36 and HIT-6). In addition, internal consistency and short- and long-term test and retest reliability will be evaluated using the intraclass correlation coefficient (ICC).
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Individuals with headache
Individuals with primary or secondary headache forms.
The Headache Disability Index will be applied:
In the translation phase:
1. Complete and assess the Dutch translation of the HDI questionnaire. The questionnaire and its evaluation can be completed online. If desired, the questionnaire can also be completed on paper, whereby the questions can be asked orally by a researcher.
OR
In the validation phase:
2. To complete the Dutch questionnaire, in combination with other questionnaires (RAND-36 questionnaire and HIT-6 questionnaire).The questionnaires can be completed online. If desired, the questionnaires can also be completed on paper. Afterwards participants will be asked to complete the HDI questionnaire again after 1 month.
Survey study
Participants will be asked to complete and evaluate the Dutch version of the Headache Disability Index. Validity (face validity, content validity, convergent validity with the RAND-36 and HIT-6) will be determined. Second, internal consistency and test-retest reliability will be evaluated.
Interventions
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Survey study
Participants will be asked to complete and evaluate the Dutch version of the Headache Disability Index. Validity (face validity, content validity, convergent validity with the RAND-36 and HIT-6) will be determined. Second, internal consistency and test-retest reliability will be evaluated.
Eligibility Criteria
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Inclusion Criteria
* At least 1 day of headache in the previous month.
* Native Dutch speaking participants
Exclusion Criteria
* Secondary headache in combination with underlying pathological situations (infection, trauma, tumors, brain haemorrhages) or severe psychotic or mental dysfunctions or substance use/withdrawal symptoms.
18 Years
65 Years
ALL
No
Sponsors
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University Ghent
OTHER
Responsible Party
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Principal Investigators
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Barbara Cagnie, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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University Hospital Ghent
Ghent, Oost-Vlaanderen, Belgium
Universiteit Gent
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ONZ-2022-0312
Identifier Type: -
Identifier Source: org_study_id
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