Hirschsprung DiseaseNCT04730128
Translation and Validation of a Disease-specific Questionnaire for Hirschsprung's Disease in Danish Patients
An observational study of Hirschsprung Disease, run by University of Southern Denmark at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Hirschsprung Disease
- How many people
- 173 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2020to 15 May 2021
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Diagnosed with Hirschsprung's Disease between the years 1985-2014
- Age > 7 years
- Good Danish comprehension
- Signed informed consent
Who cannot join
- Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation and Validation of the Hirschsprung and Anorectal Malformation Quality of Life (HAQL) Questionnaire in a Danish Hirschsprung Population
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.
- Conditions
- Hirschsprung Disease
- Keywords
- Hirschsprung Disease, Quality of Life, Translation and validation
- Medical subject headings
- Hirschsprung Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal Consistency (IC) assessed by Cronbach's Alpha
Measured: Day 1
Secondary outcomes (1)
Test-retest reliability assessed by intraclass-correlations coefficient
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Jul 2020
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Kristina Gosvig, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730128
- Sponsor's protocol ID
- 011-2018-NQ
- Status last verified
- Nov 2022
- First submitted
- 25 Jan 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Hirschsprung and Anorectal Malformation Quality of Life (HAQL) Questionnaire in a Danish Hirschsprung Population
- ClinicalTrials.gov ID
- NCT04730128
- Acronym / sponsor ID
- 011-2018-NQ
- Conditions
- Hirschsprung Disease
- Keywords
- Hirschsprung Disease, Quality of Life, Translation and validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 29 Jan 2021 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Diagnosed with Hirschsprung's Disease between the years 1985-2014
- Age > 7 years
- Good Danish comprehension
- Signed informed consent
Key exclusion criteria (1 listed)
- Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internal Consistency (IC) assessed by Cronbach's Alpha
Time frame: Day 1
1 secondary outcome
Test-retest reliability assessed by intraclass-correlations coefficient
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hirschsprung Disease, run by University of Southern Denmark at 1 site in Denmark.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency (IC) assessed by Cronbach's Alpha (time frame: Day 1). 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 9 Nov 2022.