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NCT04730128 Clinical Trial

Translation and Validation of a Disease-specific Questionnaire for Hirschsprung's Disease in Danish Patients

Hirschsprung Disease Clinical Trial

Official title:
Translation and Validation of the Hirschsprung and Anorectal Malformation Quality of Life (HAQL) Questionnaire in a Danish Hirschsprung Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04730128
Other study ID # 011-2018-NQ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date May 15, 2021

Study information
Verified date November 2022
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Hirschsprung and anorectal malformation quality of life (HAQL) questionnaire is a disease-specific quality of life questionnaire with 5 different elements (3 questionnaires for patients (categories: age 8-11, 12-16, and >17 years) and two questionnaires for parents of patients (categories: patients aged 8-11 and 12-16 years). In the first part of this study, the questionnaires will be translated via forward-backward-translation, culturally adapted and evaluated for content validity. In the second part of the study, the questionnaires will be validated in a cohort of all eligible Hirschsprung patients from Odense University Hospital from 1985-2014.

Recruitment information / eligibility
Status Completed
Enrollment 173
Est. completion date May 15, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility Inclusion Criteria: - Diagnosed with Hirschsprung's Disease between the years 1985-2014 - Age > 7 years - Good Danish comprehension - Signed informed consent Exclusion Criteria: - Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Odense University Hospital Odense Region Syddanmark

Sponsors (2)
Lead Sponsor Collaborator
University of Southern Denmark Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Internal Consistency (IC) assessed by Cronbach's Alpha Day 1
Secondary Test-retest reliability assessed by intraclass-correlations coefficient 4 weeks
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