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RecruitingNCT05619354Updated Nov 18, 2023

Validity and Reliability of the Dutch HDI

An observational study in Headache, Headache Disorders and Neck Pain, sponsored by University Ghent. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by University Ghent · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2022; still recruiting 4 years later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Headache
  • Headache Disorders
  • Neck Pain
  • Cervical Pain
03

In context

Headache

762 studies on the registry are indexed under Headache; 134 are open to participants now.

This study's planned enrollment of 250 is above the median of 139 across 168 observational studies indexed under Headache.

Browse Headache studies →

Lead sponsor

University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

The study population will consist of particants with primary and secondary headaches.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Survey study

Interventions

  • OtherSurvey 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.

06

What researchers measure

Primary outcomes

  1. Headache Disability Index

    Headache Disability Index evaluates the effects of headache on quality of life and disability

    Time frame: 15 minutes

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05619354
Lead sponsor
University Ghent
Responsible party
Sponsor
First posted
Nov 16, 2022
Start date
Nov 1, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 18, 2023

Study contacts

Marjolein Chys
Contact
Marjolein.Chys@UGent.be
+32 9 332 5635
Barbara Cagnie, Prof. Dr.
Contact
barbara.cagnie@ugent.be
+32 9 332 52 65
Barbara Cagnie, Prof. Dr.
principal investigator · University Ghent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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