Trial Review

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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] 287980 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 1762 0
Condition category
Condition code
Mental Health 1854 1854 0 0
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] 1722 0
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] 2597 0
Time between last paediatric service visit and first adult service visit
Timepoint [1] 2597 0
Assessed at 6 and 12 months, with further funding being sought to extend the trial with further timepoints at 18 months.
Primary outcome [2] 2598 0
Number of visits to adult service and retention in adult service
Timepoint [2] 2598 0
Assessed at 6 and 12 months, with further funding being sought to extend the trial with further timepoints at 18 months.
Secondary outcome [1] 4457 0
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] 4457 0
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?
No
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
90
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 4717 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 4718 0
Sydney Children's Hospital - Randwick

Funding & Sponsors
Funding source category [1] 2001 0
Charities/Societies/Foundations
Name [1] 2001 0
Diabetes Australia Research Trust
Country [1] 2001 0
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] 1812 0
Individual
Name [1] 1812 0
A/Prof Kim Donoghue
Address [1] 1812 0
Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Westmead Sydney Australia 2145
Country [1] 1812 0
Australia
Secondary sponsor category [2] 1813 0
Individual
Name [2] 1813 0
Dr Helen Woodhead
Address [2] 1813 0
Department of Paediatric Endocrinology
The Childrn's Hospital
Randwick Sydney NSW
Country [2] 1813 0
Australia
Secondary sponsor category [3] 1814 0
Individual
Name [3] 1814 0
Dr Maria Craig
Address [3] 1814 0
Institute of Endocrinology and Diabetes
The Children's Hospital at Westmead
Westmead Sydney Australia 2145
Country [3] 1814 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3710 0
Children's Hospital Westmead
Ethics committee address [1] 3710 0
Ethics committee country [1] 3710 0
Australia
Date submitted for ethics approval [1] 3710 0
Approval date [1] 3710 0
23/01/2007
Ethics approval number [1] 3710 0
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 27825 0
Prof Kate Steinbeck
Address 27825 0
Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Westmead Sydney NSW
Country 27825 0
Australia
Phone 27825 0
+612 98452507
Fax 27825 0
+612 98452517
Email 27825 0
kate.steinbeck@health.nsw.gov.au
Contact person for public queries
Name 10911 0
Prof Professor Kate Steinbeck
Address 10911 0
Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Westmead Sydney NSW
Country 10911 0
Australia
Phone 10911 0
+612 98452507
Fax 10911 0
+612 9845 2517
Email 10911 0
kate.steinbeck@health.nsw.gov.au
Contact person for scientific queries
Name 1839 0
Prof Professor Kate Steinbeck
Address 1839 0
Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Westmead Sydney NSW
Country 1839 0
Australia
Phone 1839 0
+612 98452507
Fax 1839 0
Email 1839 0
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
SourceTitleYear of PublicationDOI
EmbaseA pilot randomized controlled trial of a post-discharge program to support emerging adults with type 1 diabetes mellitus transition from pediatric to adult care.2015https://dx.doi.org/10.1111/pedi.12229
N.B. These documents automatically identified may not have been verified by the study sponsor.