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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730128
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : February 3, 2021
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Kristina Gosvig, University of Southern Denmark

Study Description
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Brief 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.


Condition or disease
Hirschsprung Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Translation and Validation of the Hirschsprung and Anorectal Malformation Quality of Life (HAQL) Questionnaire in a Danish Hirschsprung Population
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Internal Consistency (IC) assessed by Cronbach's Alpha [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Test-retest reliability assessed by intraclass-correlations coefficient [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Based on the ICD-10 code for Hirschsprung's disease, all patients with Hirschsprung's disease diagnosed in Odense University Hospital will be offered to participate in the study. The diagnosis must be registered between the years 1985-2014 and the patient must be > 7 years at the study initiation.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730128


Contacts
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Contact: Kristina Gosvig, MD +45 5152 0696 kristinagosvig@gmail.com

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Region Syddanmark, Denmark, 5000
Contact: Kristin Gosvig, MD    +45 5152 0696    kristinagosvig@gmail.com   
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
More Information
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Responsible Party: Kristina Gosvig, Principal Investigator, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT04730128    
Other Study ID Numbers: 011-2018-NQ
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristina Gosvig, University of Southern Denmark:
Hirschsprung Disease
Quality of Life
Translation and validation
Additional relevant MeSH terms:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Megacolon
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities