NCT03270267

Brief Summary

Study of the causes and rate of school absenteeism in children and adolescents with Inflammatory Bowel Disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

August 30, 2017

Last Update Submit

March 8, 2019

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • Number of days of absence from school due to IBD

    Month 10

Secondary Outcomes (2)

  • Comparison of the rate of school absenteeism of a child with IBD to the data of the school academy where she/he is enrolled

    Month 10

  • Study of repercussion of the number of days of absence due to IBD on school results

    Month 10

Study Arms (1)

Patients with IBD

Other: Questionnaires

Interventions

QuestionnairesOTHER
Patients with IBD

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with IBD

You may qualify if:

  • Child aged 6 to 18 years old
  • Child with definite diagnosis of IBD for at least 6 months
  • Follow-up by a gastroenterologist of Rennes University Hospital on a regular basis (at least 2 annual consultations)
  • Non-opposition of the child and the parents

You may not qualify if:

  • School leaving
  • Student at the University
  • Other serious disease outside IBD preventing normal schooling
  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35200, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

September 1, 2016

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

March 11, 2019

Record last verified: 2019-03

Locations

FR(1)