HeadacheNCT05619354
Validity and Reliability of the Dutch HDI
An observational study of Headache and Headache Disorders, run by University Ghent at 2 sites in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache, Headache Disorders, Neck Pain
- What is being tested?
- Survey study
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Nov 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: The study population will consist of particants with primary and secondary headaches.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
University Hospital Ghent
Ghent, Oost-Vlaanderen, 9000
Barbara Cagnie, PhD, barbara.cagnie@ugent.be
- Recruiting
Universiteit Gent
Ghent, 9000
Marjolein Chys, Marjolein.Chys@Ugent.be
Indra De Greef, indra.degreef@ugent.be
About this study
Official title: Validity and Reliability of the Dutch Version of the Headache Disability Inventory (HDI) Questionnaire
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).
- Conditions
- Headache, Headache Disorders, Neck Pain, Cervical Pain
- Being tested
- Survey study
- Medical subject headings
- Headache, Headache Disorders, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Disability Index
Headache Disability Index evaluates the effects of headache on quality of life and disability
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Cagnie, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619354
- Sponsor's protocol ID
- ONZ-2022-0312
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Dutch Version of the Headache Disability Inventory (HDI) Questionnaire
- ClinicalTrials.gov ID
- NCT05619354
- Acronym / sponsor ID
- ONZ-2022-0312
- Conditions
- Headache, Headache Disorders, Neck Pain, Cervical Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with headache | – | Other: Survey studyIndividuals 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of particants with primary and secondary headaches.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey studyParticipants 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. | Other | Individuals with headache |
Primary outcome
Headache Disability Index
Time frame: 15 minutes
Headache Disability Index evaluates the effects of headache on quality of life and disability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Cagnie, Prof. Dr. principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache and Headache Disorders, run by University Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marjolein Chys (+32 9 332 5635, Marjolein.Chys@UGent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Disability Index (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.