Validity and Reliability of the Dutch HDI

Neck Pain Clinical Trial

Official title:

Validity and Reliability of the Dutch Version of the Headache Disability Inventory (HDI) Questionnaire

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05619354
• Other study ID #: ONZ-2022-0312
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University Ghent
• Contact: Marjolein Chys
• Phone: +32 9 332 5635
• Email: Marjolein.Chys[@]UGent.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Pain
• Headache
• Headache Disorders
• Neck Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Belgium	Universiteit Gent	Ghent
Belgium	University Hospital Ghent	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Disability Index	Headache Disability Index evaluates the effects of headache on quality of life and disability	15 minutes