Crohn DiseaseQALY-ECOPEDNCT04881370
Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)
An observational study of Crohn Disease and Ulcerative Colitis, run by University Hospital, Lille at 1 site in France.
Trial summary
The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of… Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- How many people
- 298 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2020to 28 Jun 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 12 to 24 years
- All sexes
- Child, Adult
Study population: Patients with pediatric-onset IBD (diagnosed before the age of 17) and aged over 12 and under 25 at the time of the study.
Who may be able to join
- Male or female, between 12 and 24 years old included at the time of the study
- Subject listed in the EPIMAD registry suffering from certain or probable Crohn's disease, or certain or probable ulcerative colitis, or certain or probable ulcerative proctitis
- Disease diagnosed before the age of 17 (pediatric onset disease)
- Patient residing in the area of the EPIMAD register at the time of diagnosis: Nord, Pas-de-Calais, Somme or Seine-Maritime
- Patient not opposing the research
- Patient not having objected to the use of these data for ancillary studies when registering in the EPIMAD register
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.
Read the detailed description
The continuous increase in incidence of chronic inflammatory bowel disease (IBD) will increase their burden on health care costs in the future. Pediatric IBD is frequently associated with an aggressive phenotype causing specific complications (undernutrition, pubertal delay or height-weight loss) and has a long-term impact on quality of life.
Therapeutic evolutions were marked in the 1990s by the arrival of immunosuppressants and then in the 2000s of biotherapies (anti-TNF).To limit the accumulation of tissue damage and to benefit from the maximum effectiveness of anti -TNF, clinicians are tempted to offer early treatment of CD with anti-TNF.
An ongoing study using data from the EPIMAD registry aims to study the impact of therapies on the disease course of patients with IBD in their childhood (Inspired study). This study also contains a medico-economic component, the objective of which is to evaluate the cost-effectiveness of the different management strategies for pediatric onset IBD. As part of this economic study, quality of life data will be needed. Indeed, there are very few data on quality of life in children / adolescents with IBD in the literature. These data must be collected from patients, unlike the other data used (retrospective data, in medical records).
The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.
This study will supplement data currently being collected from patients over 25 years of age, quality of life being the subject of a secondary objective of a study on the professional integration of patients with IBD (PROMICI study , ID-RCB: 2017-A03397-46).
- Conditions
- Crohn Disease, Ulcerative Colitis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life according to age and disease activity
Quality of life is measured by EQ5D-5L questionnaire and transformed into utility according to French reference values
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Correlation between EQ5D-5L and SIBDQ questionnaire in adults
EQ5D-5L is a generic measure of quality of life and SIBDQ a disease-specific questionnaire of quality of life
Measured: through study completion, an average of 1 year
Correlation between EQ5D-5L and IMPACT III questionnaire in adolescents
EQ5D-5L is a generic measure of quality of life and IMPACT III a disease-specific questionnaire of quality of life
Measured: through study completion, an average of 1 year
Quality of life according to previous surgery occurence
Quality of life is measured by EQ5D-5L
Measured: through study completion, an average of 1 year
Correlation between quality of life and perceived health
Quality of life measured by EQ5D-5L and perceived health by Visual Analogue Scale
Measured: through study completion, an average of 1 year
Quality of life according to profession and academic degree (adults only)
Quality of life as measured by EQ5D-5L
Measured: through study completion, an average of 1 year
Quality of life according to profession and academic degree (adults only)
Quality of life as measured by SIBDQ
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start9 Oct 2020
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Why it stopped: insufficiency inclusion during the inclusion periode
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Dominique TURCK, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881370
- Sponsor's protocol ID
- 2020_70
- Other IDs
- 2020-A00464-35, PRME-15-0464
- Acronym
- QALY-ECOPED
- Status last verified
- Jan 2023
- First submitted
- 3 May 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT04881370
- Acronym / sponsor ID
- QALY-ECOPED / 2020_70
- Conditions
- Crohn Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficiency inclusion during the inclusion periode
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 11 May 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 main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.
Detailed description
The continuous increase in incidence of chronic inflammatory bowel disease (IBD) will increase their burden on health care costs in the future. Pediatric IBD is frequently associated with an aggressive phenotype causing specific complications (undernutrition, pubertal delay or height-weight loss) and has a long-term impact on quality of life.
Therapeutic evolutions were marked in the 1990s by the arrival of immunosuppressants and then in the 2000s of biotherapies (anti-TNF).To limit the accumulation of tissue damage and to benefit from the maximum effectiveness of anti -TNF, clinicians are tempted to offer early treatment of CD with anti-TNF.
An ongoing study using data from the EPIMAD registry aims to study the impact of therapies on the disease course of patients with IBD in their childhood (Inspired study). This study also contains a medico-economic component, the objective of which is to evaluate the cost-effectiveness of the different management strategies for pediatric onset IBD. As part of this economic study, quality of life data will be needed. Indeed, there are very few data on quality of life in children / adolescents with IBD in the literature. These data must be collected from patients, unlike the other data used (retrospective data, in medical records).
The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.
This study will supplement data currently being collected from patients over 25 years of age, quality of life being the subject of a secondary objective of a study on the professional integration of patients with IBD (PROMICI study , ID-RCB: 2017-A03397-46).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with pediatric-onset IBD (diagnosed before the age of 17) and aged over 12 and under 25 at the time of the study.
Key inclusion criteria (6 listed)
- Male or female, between 12 and 24 years old included at the time of the study
- Subject listed in the EPIMAD registry suffering from certain or probable Crohn's disease, or certain or probable ulcerative colitis, or certain or probable ulcerative proctitis
- Disease diagnosed before the age of 17 (pediatric onset disease)
- Patient residing in the area of the EPIMAD register at the time of diagnosis: Nord, Pas-de-Calais, Somme or Seine-Maritime
- Patient not opposing the research
Key exclusion criteria (1 listed)
- No exclusion criteria
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
Quality of life according to age and disease activity
Time frame: through study completion, an average of 1 year
Quality of life is measured by EQ5D-5L questionnaire and transformed into utility according to French reference values
6 secondary outcomes
Correlation between EQ5D-5L and SIBDQ questionnaire in adults
Time frame: through study completion, an average of 1 year
Correlation between EQ5D-5L and IMPACT III questionnaire in adolescents
Time frame: through study completion, an average of 1 year
Quality of life according to previous surgery occurence
Time frame: through study completion, an average of 1 year
Correlation between quality of life and perceived health
Time frame: through study completion, an average of 1 year
Quality of life according to profession and academic degree (adults only)
Time frame: through study completion, an average of 1 year
Quality of life according to profession and academic degree (adults only)
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: insufficiency inclusion during the inclusion periode). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
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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.
Dominique TURCK principal investigator
University Hospital, Lille
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 Crohn Disease and Ulcerative Colitis, run by University Hospital, Lille at 1 site in France.
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 6 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: stopped early, as of the sponsor's last update on 19 Jan 2023. 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 France. 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 was stopped early (reason given: insufficiency inclusion during the inclusion periode). Results are not available in the source record.
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?
Quality of life according to age and disease activity (time frame: through study completion, an average of 1 year). 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 19 Jan 2023.