Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000259741
Ethics application status
Approved
Date submitted
4/03/2013
Date registered
5/03/2013
Date last updated
27/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes of patients with paediatric onset Inflammatory Bowel Disease (IBD) following transition into adult care –what do we know?
Scientific title
In patients with paediatric onset Inflammatory Bowel Disease (IBD) who have transitioned to adult care, what are their health outcomes.
Secondary ID [1] 282049 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 288522 0
Condition category
Condition code
Oral and Gastrointestinal 288854 288854 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to identify the physical and psychosocial outcomes of patients with paediatric onset IBD who have transitioned to adult care, which may have been adversely influenced by their transition process. We aim to identify these outcomes and patient perspectives of the process through a questionnaire.

The questionnaire will be given once during the observational period and will look at their IBD from the time of diagnosis until the date of the questionnaire (All patients included - maximum 10years). The questionnaire does not have a specific name. The entire study will run for 1 year.
Intervention code [1] 286641 0
Not applicable
Comparator / control treatment
Control - group of patients diagnosed with IBD as an adult who have not undergone the transition process. This control group will not be given a questionnaire. Data regarding their health outcomes has previously been collected.
Source of data - Medical records data for suitable patients 2002-2012
Control group
Historical

Outcomes
Primary outcome [1] 288983 0
Health outcomes of patients with paediatric onset IBD who have transitioned to adult care. Health outcomes will be obtained through the questionnaire.
Timepoint [1] 288983 0
Patients surveyed have to have transitioned to adult care. This is a once off survey and consequently this outcome will be assessed as soon as the patient has consented to participate.
Secondary outcome [1] 301498 0
Patient perspectives on the transition process - through the questionnaire.
Timepoint [1] 301498 0
This is a once off survey and consequently this outcome will be assessed as soon as the patient has consented to participate.

Eligibility
Key inclusion criteria
>18years of age
Diagnosis of IBD in paediatric years
Has to have transitioned to adult care
Minimum age
18 Years
Maximum age
28 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age<17years

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/03/2013
Actual
5/03/2013
Date of last participant enrolment
Anticipated
Actual
31/12/2013
Date of last data collection
Anticipated
Actual
31/12/2013
Sample size
Target
200
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 703 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 704 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 6446 0
5000 - Adelaide
Recruitment postcode(s) [2] 6447 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 286822 0
Commercial sector/Industry
Name [1] 286822 0
Abbott
Country [1] 286822 0
Australia
Primary sponsor type
Government body
Name
SA Department of Health
Address
Citi Centre Building, 11 Hindmarsh Square, Adelaide SA 5000
Postal Address: PO Box 287, Rundle Mall, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 285633 0
None
Name [1] 285633 0
Address [1] 285633 0
Country [1] 285633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288889 0
WCHN Human Research Ethics Committee
Ethics committee address [1] 288889 0
72 King William Road
North Adelaide
SA
5006
Ethics committee country [1] 288889 0
Australia
Date submitted for ethics approval [1] 288889 0
Approval date [1] 288889 0
10/01/2013
Ethics approval number [1] 288889 0
REC 2518/11/2015 LNR-HREC/12/WCHN/95

Summary
Brief summary
Despite multiple studies reporting outcomes separately in both adult and paediatric cohorts and existing literature about transition care, little data has been published regarding the outcomes of patients with paediatric onset Inflammatory Bowel Disease (IBD) in the years after they have entered adult care. This is important as major changes in transition practices are currently being recommended without knowing what is actually happening to this group of IBD patients and what is needed.

This study aims to identify the physical and psychosocial outcomes of this cohort, which may have been adversely influenced by their transition process, in addition to patient perspectives of the process.

The project will achieve its aims by using a database from the Women’s and Children’s Hospital which contains a list of patients with paediatric onset IBD that have since transitioned into adult care (defined as having turned 18 at the time of interrogating the database). Participants will be contacted and invited to participate in a survey which will collect data regarding basic demographic information, IBD-associated health outcomes, transition experiences and perceived positives and negatives from the transition process. Health outcomes of this population will then be compared to both local and published data of adult onset IBD patients of similar disease duration. Current guidelines of management of IBD in this cohort will also be compared to the study group.

From this information, obstacles to optimal transition will be highlighted, and patients views obtained. These data will be vital to guide the successful development of new and improved transition programs which optimise patient care. This has the potential to improve disease-specific and psychological outcomes for these patients and thus also reduce the direct and indirect economic burden in this cohort.
Trial website
Trial related presentations / publications
1. Bennett AL, Moore D, Bampton PA, Bryant RV, Andrews JA. Outcomes and patients’ perspectives of transition from paediatric to adult care in Inflammatory Bowel Disease. World J Gastroenterol. 2016; 22(8): 2611-2620. Doi:10.3748/wjg.v22.i8.2611 PMID: 26937149
Public notes
Attachments [1] 2916 2916 0 0
/AnzctrAttachments/363795-22854 - Manuscript for copyright.docx (Publication)

Contacts
Principal investigator
Name 38238 0
Dr Alice Bennett
Address 38238 0
Level 7
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 38238 0
Australia
Phone 38238 0
+61 4 288 30 979
Fax 38238 0
Email 38238 0
[email protected]
Contact person for public queries
Name 38239 0
Alice Bennett
Address 38239 0
Level 7
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 38239 0
Australia
Phone 38239 0
+61 8 8222 5207
Fax 38239 0
Email 38239 0
[email protected]
Contact person for scientific queries
Name 38240 0
Alice Bennett
Address 38240 0
Level 7
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 38240 0
Australia
Phone 38240 0
+61 8 8222 5207
Fax 38240 0
Email 38240 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.