Validity and Reliability of the Dutch HDI

NCT05619354 | Unknown

• 1 other identifier: ONZ-2022-0312
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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).

Conditions

Headache; Headache Disorders; Neck Pain; Cervical Pain

Outcome Measures

Primary Outcomes (1)

• Headache Disability Index

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

  15 minutes

Study Arms (1)

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

Survey study OTHER

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.

Individuals with headache

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead

Study Sites (2)

University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Universiteit Gent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Headache; Headache Disorders; Neck Pain

Interventions

Longitudinal Studies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Barbara Cagnie, Prof. Dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjolein Chys

CONTACT

+32 9 332 5635; Marjolein.Chys@UGent.be

Barbara Cagnie, Prof. Dr.

CONTACT

+32 9 332 52 65; barbara.cagnie@ugent.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 16, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)