Chronic Inflammatory Bowel Diseases (IBD) and School Abse... | NCT03270267

Studies
Chronic Inflammatory Bowel Diseases (IBD) and School Absenteeism

NCT03270267

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Mar 11, 2019Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Inflammatory Bowel Diseases

Interventions

Questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Feb 28, 2018Actual

Completion Date

Feb 28, 2018Actual

First Submitted Date

Aug 30, 2017

First Submission Date that Met QC Criteria

Aug 31, 2017

First Posted Date

Sep 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2019

Last Update Posted Date

Mar 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Label	Type	Description	Intervention Names
Patients with IBD			Other: Questionnaires

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Other		Patients with IBD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of days of absence from school due to IBD		Month 10

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients with IBD

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Rennes		Rennes		35200	France

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided