Validity and Reliability of the Dutch HDI

November 15, 2023 updated by: University Ghent

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Disability Index
Time Frame: 15 minutes
Headache Disability Index evaluates the effects of headache on quality of life and disability
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Barbara Cagnie, Prof. Dr., University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2022-0312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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