ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000231448

Ethics application status

Approved

Date submitted

24/04/2007

Date registered

1/05/2007

Date last updated

24/11/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Transition from paediatric to adult care in Type 1 diabetes mellitus

Scientific title

Transition from paediatric to adult care in Type 1 diabetes mellitus comparing standard clinical practice with a comprehensive transition program which provides additional resources and support to young people with Type 1 diabetes mellitus; factors associated with successful transfer and early engagement in adult health care.

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Type 1 diabetes mellitus

Condition category

Condition code

Mental Health

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention group will receive a comprehensive transition program which includes comprehensive exit preparation, introduction to the new service (using internet), Health care information transfer in both hard copy and using memory sticks, Communication support between the last paediatric visit and the first adult visit and access to the trial co-ordinator. Individual clinicians within the service may vary in practice and these practices will be recorded. The duration of the intervention is for 18 months

Intervention code [1]

Other interventions

Comparator / control treatment

The comparator (control) treatment will is generally no interevention once the young person has been discharged from the paediatric service. Individual clinicians within the service may vary in practice and these practices will be recorded. The duration of the intervention is for 18 months

Control group

Active

Outcomes

Primary outcome [1]

Time between last paediatric service visit and first adult service visit

Timepoint [1]

Assessed at 6 and 12 months, with further funding being sought to extend the trial with further timepoints at 18 months.

Primary outcome [2]

Number of visits to adult service and retention in adult service

Timepoint [2]

Assessed at 6 and 12 months, with further funding being sought to extend the trial with further timepoints at 18 months.

Secondary outcome [1]

Diabetes related phone contacts; change to alternate adult service; diabetes related hospital admissions; glycaemic control by HbA1c; microvascular complication assessment by self report and report by Diabetes Service using presence of absence of retinopathy and presence or absence of microalbuminuria; emotional and psychosocial wellbeing using Child Health Questionnaire, Harter self-perception questionnaire and Diabetes knowledge and competency questionnaire.

Timepoint [1]

At 0 & 6 and 12 months and at 18 months if funding allows.

Eligibility

Key inclusion criteria

Type 1 Diabetes Mellitus. In practice the upper age limit will be less than 20 years but older subjects will be included to 24 years (youth) if they have not been discharged from paediatric care and if they have never seen an adult diabetes service.

Minimum age

16 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Type 2 Diabetes mellitus

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed sequential envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computer generated by trial statistician

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

The subjects and trial co-ordinator (therapist) are not blinded by nature of the design. The participants will be requested not to reveal their intervention group to their clinicans. The assessors (the principle investigators) and those responsible for data analysis (principle investigators and statistician) will be blinded to the participant status.

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2007

Actual

26/11/2007

Date of last participant enrolment

Anticipated

19/12/2007

Actual

18/06/2008

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Children's Hospital at Westmead - Westmead

Recruitment hospital [2]

Sydney Children's Hospital - Randwick

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Diabetes Australia Research Trust

Address [1]

http://www.diabetesaustralia.com.au/Research/DART/

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Kate Steinbeck

Address

Changed since the trial completed.
Academic Department of Adolescent Medicine
The Children's Hospital at westmead
Westmead Sydney Australia 2145

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

A/Prof Kim Donoghue

Address [1]

Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Westmead Sydney Australia 2145

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr Helen Woodhead

Address [2]

Department of Paediatric Endocrinology
The Childrn's Hospital
Randwick Sydney NSW

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Dr Maria Craig

Address [3]

Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Westmead Sydney Australia 2145

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Hospital Westmead

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/01/2007

Ethics approval number [1]

2006/117

Summary

Brief summary

It is known that transition from paediatric to adult care in Type 1 dibetes mellitus is often difficult. Young people are anxious about leaving a familiar service. In adult health care they are 'diluted' where Type 2 diabetes mellitus predominates. Australian figures suggest that up to 50% of young adults with Type 1 diabetes are not in specialist care. Failure to engage with specialist care means poor diabetes care and control, and the risk of medium and long term poor health outcomes. We hypothesise that a comprehensive transition program involving communication, mentoring and health professional support will improvement engagement with adult health care better than current clinic practice.This study aims to determine what resources and support are needed to ensure that successful transition occurs. The literature suggest that it is not enough that young people arrive at their first appointment to an adult service; they need to stay engaged and hence the reason for the longer term nature of the study, following young people for up to 18 months after discharge from paediatric servcies

Trial website

Trial related presentations / publications

Steinbeck KS, Shrewsbury VA, Harvey V, Mikler K, Donaghue KC, Craig ME, Maria E. Craig, Woodhead HJ. A Pilot Randomized Controlled Trial of a Post-Discharge Program to Support Emerging Adults with Type 1 Diabetes Mellitus Transition from Pediatric to Adult Care. Pediatric Diabetes. Accepted 18/9/2014. and in final production stage November 2015

Public notes

Contacts

Principal investigator

Name

Prof Kate Steinbeck

Address

Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Westmead Sydney NSW

Country

Australia

Phone

+612 98452507

Fax

+612 98452517

kate.steinbeck@health.nsw.gov.au

Contact person for public queries

Name

Professor Kate Steinbeck

Address

Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Westmead Sydney NSW

Country

Australia

Phone

+612 98452507

Fax

+612 9845 2517

kate.steinbeck@health.nsw.gov.au

Contact person for scientific queries

Name

Professor Kate Steinbeck

Address

Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Westmead Sydney NSW

Country

Australia

Phone

+612 98452507

Fax

kate.steinbeck@health.nsw.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

Source	Title	Year of Publication	DOI
Embase	A pilot randomized controlled trial of a post-discharge program to support emerging adults with type 1 diabetes mellitus transition from pediatric to adult care.	2015	https://dx.doi.org/10.1111/pedi.12229

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically