Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001179527
Ethics application status
Approved
Date submitted
14/10/2015
Date registered
3/11/2015
Date last updated
6/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the role of an individualised healthcare transition document for young people with disabilities transitioning from Paediatric services to Primary Care.
Scientific title
In young people with disabilities transitioning from paediatrics services, does a structured healthcare document and process improve readiness to transition.
Secondary ID [1] 287658 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical and intellectual disability
 296491 0
Condition category
Condition code
Public Health 296747 296747 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Formal healthcare transition document (written form) created for general practitioners and families.
Information recorded=medical background, medications, allergies, list of all issues with current management and future management requirements. Information for families and GP's providing contact details of resources.
Completed by the pediatrician caring for that patient (in discussion with patient and their family)
Completed at any time during the transition process which takes place from 14-18 years and will act as a document both during this time and also once they have transitioned. It may need to be updated over time until they are finally passed onto the General Practitioner. (who will manage their medical care after pediatrics)
Intervention code [1] 293053 0
Other interventions
Comparator / control treatment
No control group
Pre and post intervention outcome analysis
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296363 0
Scores on pre validated clinical tool assessing transition readiness such as a modified UNC TR(x)ANSITION Scale developed and validated in 2012 by the University of North Carolina before and after the intervention and at the same time points for the control group.
The wording has been modified so it suits developmental/intellectual disability.
Ferris ME, Harward DH, Bickford K, Layton JB, Ferris MT, Hogan SL, Gipson DS, McCoy LP, Hooper SR (2012), A clinical tool to measure the components of health-care transition from paediatric care to adult care: the UNC TR(x)ANSITION scale, Renal Failure, 34(6), 744-53.
Timepoint [1] 296363 0
1 month following administration of health care transition document.
Secondary outcome [1] 318247 0
Number of and reason for GP visits - from GP records (as per ethics approval)
Timepoint [1] 318247 0
6 months from the time of health care transition document administration
Secondary outcome [2] 318425 0
Composite secondary outcome:
feedback questionnaire for the GP, physician and family. This Questionnaire has been designed for this study and uses a mix of three option answers to obtain quantitative information and open questions.
Timepoint [2] 318425 0
1 month from the time of transition document administration
Secondary outcome [3] 318426 0
Number of a reason for emergency department presentation - from hospital records as per ethics approval.
Timepoint [3] 318426 0
6 months from the time of transition document administration

Eligibility
Key inclusion criteria
Young people and their families age 14 -18 years who have physical/intellectual/developmental disabiliites and are at or near transition time from paediatrics to general practice.
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Isolated Autism Specturm Disorder without Intellectual disability.
Isolated ADHD without Intellectual Disability
Intepreter needed due to language barrier

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/10/2015
Date of last participant enrolment
Anticipated
31/12/2015
Actual
24/12/2015
Date of last data collection
Anticipated
Actual
29/07/2016
Sample size
Target
15
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 7238 0
New Zealand
State/province [1] 7238 0
South Auckland

Funding & Sponsors
Funding source category [1] 292217 0
Self funded/Unfunded
Name [1] 292217 0
No funding
Country [1] 292217 0
Primary sponsor type
Individual
Name
Emma Cluett
Address
14 Hemi Street
Devonport
Auckland
0622
Country
New Zealand
Secondary sponsor category [1] 290892 0
None
Name [1] 290892 0
Address [1] 290892 0
Country [1] 290892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293688 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 293688 0
Ethics committee country [1] 293688 0
New Zealand
Date submitted for ethics approval [1] 293688 0
18/08/2015
Approval date [1] 293688 0
06/10/2015
Ethics approval number [1] 293688 0
15/NTB/151

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60966 0
Dr Emma Cluett
Address 60966 0
Private Postal Address
14 hemi St
Devonport
Auckland 0622

Work organisation address
Middlemore Hospital
Private Bag 93 311
Otahuhu
Auckland 1640
Country 60966 0
New Zealand
Phone 60966 0
0064211075065
Fax 60966 0
Email 60966 0
eclu001@gmail.com
Contact person for public queries
Name 60967 0
Emma Cluett
Address 60967 0
Private postal
14 hemi St
Devonport
Auckland 0622

Work organisation address
Middlemore Hospital
Private Bag 93 311
Otahuhu
Country 60967 0
New Zealand
Phone 60967 0
0064211075065
Fax 60967 0
Email 60967 0
eclu001@gmail.com
Contact person for scientific queries
Name 60968 0
Emma Cluett
Address 60968 0
Private postal
14 hemi St
Devonport
Auckland 0622

Work organisation address
Middlemore Hospital
Private Bag 93 311
Otahuhu
Country 60968 0
New Zealand
Phone 60968 0
0064211075065
Fax 60968 0
Email 60968 0
eclu001@gmail.com

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.