Clinical trial NCT05619354: Validity and Reliability of the Dutch HDI
Official title: Validity and Reliability of the Dutch Version of the Headache Disability Inventory (HDI) Questionnaire
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Headache
Headache Disorders
Neck Pain
Cervical Pain
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of particants with primary and secondary headaches.

Brief summary: The aim of our study is to investigate the validity and reliability of Dutch version of the Henry Ford Hospital Headache Disability Questionnaire (HDI).

Detailed description: There is only a limited number of questionnaires that map headache-related disability.

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).

Eligibility criteria: Inclusion Criteria:

* Patients with primary or secondary headache, diagnosed by a neurologist according to the ICHD-3 classification.
* At least 1 day of headache in the previous month.
* Native Dutch speaking participants

Exclusion Criteria:

* All other headache types not classified by the ICHD-3 as primary or secondary headache.
* Secondary headache in combination with underlying pathological situations (infection, trauma, tumors, brain haemorrhages) or severe psychotic or mental dysfunctions or substance use/withdrawal symptoms.

Primary outcomes:
measure: Headache Disability Index
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: Oost-Vlaanderen
city: Ghent
country: Belgium
facility: Universiteit Gent
Study officials:
affiliation: University Ghent
name: Barbara Cagnie, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: