ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Inflammatory Bowel Disease

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

Health outcomes of patients with paediatric onset IBD who have transitioned to adult care. Health outcomes will be obtained through the questionnaire.

Timepoint [1]

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]

Patient perspectives on the transition process - through the questionnaire.

Timepoint [1]

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?

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

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Abbott

Address [1]

32-34 Lord St
Botany, NSW 2019
Locked Bag 5016
Botany, NSW 1455

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WCHN Human Research Ethics Committee

Ethics committee address [1]

72 King William Road
North Adelaide
SA
5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/01/2013

Ethics approval number [1]

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]

/AnzctrAttachments/363795-22854 - Manuscript for copyright.docx (Publication)

Contacts

Principal investigator

Name

Dr Alice Bennett

Address

Level 7
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 4 288 30 979

Fax

alice.bennett@health.sa.gov.au

Contact person for public queries

Name

Alice Bennett

Address

Level 7
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 8 8222 5207

Fax

alice.bennett@health.sa.gov.au

Contact person for scientific queries

Name

Alice Bennett

Address

Level 7
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 8 8222 5207

Fax

alice.bennett@health.sa.gov.au

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.

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