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Trial registered on ANZCTR
Registration number
ACTRN12620000074998
Ethics application status
Approved
Date submitted
21/11/2019
Date registered
30/01/2020
Date last updated
30/01/2020
Date data sharing statement initially provided
30/01/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Transition Mate: A Mobile Phone App to Support Self-Management and Transition in Young People with Chronic Illness
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Scientific title
Transition Mate: A Mobile Phone App to Support Self-Management and Transition in Young People with Chronic Illness
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Secondary ID [1]
297908
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Nil
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Universal Trial Number (UTN)
U1111-1231-3220
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic illnesses in Adolescents
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Transition of care
315244
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Condition category
Condition code
Public Health
310846
310846
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Downloading and use of the Transition Mate mobile phone application as an intervention to assist transition of adolescents from paediatric to adult clinic services.
The Transition Mate mobile phone application is downloaded onto the participant's mobile phone once the study has been explained and consent has been obtained. Download is performed by the participant under the guidance of the researcher. The download would be available from the Apple Store (ios) or Google Play Store (android). Use of the application would involve the participant opening the mobile application and using the features within. These features are:
• To do lists
• Appointment schedules
• Medication Lists
• Linking with calendar and contact.
• Images (Take and save photos)
• Mood tracker
The number of times the intervention (Transition Mate application) and the features used are determined by the participant. This will be reviewed at the 6, 12 and 18 months followup phone calls as well as using application analytics (these are de-identified, with cohort data available for analysis)
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Intervention code [1]
316107
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Prevention
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Intervention code [2]
316108
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Behaviour
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Intervention code [3]
316109
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Lifestyle
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Comparator / control treatment
Comparator consists of historical data with regards to health care outcomes of adolescents transitioned from paediatric to adult medical services.
Source of historical data from the following source:
1) Perry L, Steinbeck KS, Dunbabin JS, Lowe JM. Lost in transition? Access to and uptake of adult health services and outcomes for young people with type 1 diabetes in regional New South Wales. Med J Aust 2010 Oct;193(8):444-9.
-> Case note audit of 239 young adults aged 18-28 years with type 1 diabetes accessing five adult diabetes services before 30 June 2008 in three geographical regions of New South Wales
2) Garvey KC, Markowitz JT, Laffe LMB. Transition to Adult Care for Youth with Type 1 Diabetes. Curr Diab Rep 2012 Oct;12(5):533-541.
as well as:
1) Steinbeck KS, Brodie L, Towns S. Transition in chronic illness: Who is going where? Journal of Paediatrics and Child Health 2008 Aug, 44(9), 478-482.
-> Data were collected between August 2004 and October 2005 through face-to-face interviews with over 200 clinicians in 68 clinical services in tertiary paediatric hospitals in New South Wales, providing information on approximately 4200 patients
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Control group
Historical
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Outcomes
Primary outcome [1]
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To examine the effectiveness of the TransitionMate application by comparing individual user interactions with the rates of engagement and retention within adult services in young people with any chronic illness transitioning from paediatric to adult care. Outcome is primarily assessed using study-specific questionnaires (for both the participants as well as their adult care providers) at time-points detailed below. This will be supplemented by information from hospital databases as well as TransitionMate usage analytics.
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Assessment method [1]
322006
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Timepoint [1]
322006
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At 6 months, 12 months (primary endpoint) and 18 months after last clinic appointment at paediatric service.
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Primary outcome [2]
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To determine illness control during the first 12 months after transfer from paediatric to adult services in young people using the TransitionMate application.
Illness controls are measured by relevant markers of disease control including HbA1c (T1DM), FEV1 (CF) and number of hospitalisations) obtained from the adult service or patient self-report. via study-specific questionnaires. This will be supplemented by information from hospital databases.
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Assessment method [2]
322007
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Timepoint [2]
322007
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At 6 months and 12 months (primary endpoint) after last clinic appointment at paediatric service.
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Secondary outcome [1]
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To assess the number of unplanned/emergency hospital admissions duing the first 12 months after transfer from paediatric to adult services in young people using the TransitionMate application.
Outcome is primarily assessed using study-specific questionnaires (for both the participants as well as their adult care providers) at time-points detailed below. This will be supplemented by information from hospital databases.
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Assessment method [1]
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Timepoint [1]
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At 6 months and 12 months (primary endpoint) after last clinic appointment at paediatric service.
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Eligibility
Key inclusion criteria
- Current patients of The Sydney Children’s Hospital Network who have a chronic illness (for example, Type 1 Diabetes Mellitus, Cystic Fibrosis, Inflammatory Bowel disease)
- Transitioning to adult services within the next 12 months.
- Consent to use the TransitionMate app and follow-up for 18 months
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Minimum age
16
Years
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Intellectual disability affecting use of mobile phone application
- Primary diagnosis of mental health disorder
- No access to personal iPhone/Android mobile phone
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
The TransitionMate research study is a two centre, pragmatic, single arm, mixed methods cohort study. As this is a single arm study, there will be no randomisation/ allocation process on recruitment. Results are compared with historical data.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
There is limited empirical evidence on the effectiveness of current transition programs in regard to engagement with and retention in adult services or on rates of deterioration in illness control on which to base power calculations. In the diabetes literature, approximately 70% of adolescents will make some transition from paediatric to adult services. Using a predicted attrition rate of 30%, a sample size of 70 participants will be needed to obtain the minimum sample of 49 adolescents required for this study. A sample of 49 adolescents will have greater than or equal to 80% power at 5% one-sided alpha, to detect an increase in the rate of successful transition from paediatric to adult care from 70%.
The primary outcome as the percentage of adolescents who successfully engage and are retained within the adult health care services will be described using a 90% exact binomial confidence interval. If the lower confidence limit is less than or equal to 70%, the TransitionMate application would not be considered effective in terms of increasing rates of engagement and retention within the adult services.
Participant demographics, clinical characteristics and study outcomes will be described using standard methods, including frequencies and percentages for categorical variables, and mean, standard deviation, median, quartiles and range for continuous variables. Kaplan-Meier methods will be used for time-to-event variables. Study outcomes will be described in the total cohort as well as by chronic illness group, acknowledging that sub-group numbers will limit further analyses.
Linear, logistic or proportional hazards regression models will be used to examine predictors of study outcomes including TransitionMate application use, age, gender, illness, transition readiness and mental health status in univariate models and models adjusted for potential confounders including other transition programs, use of other applications and deterioration in illness control. All effects will be presented with confidence intervals where possible.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
13/05/2019
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Date of last participant enrolment
Anticipated
30/04/2021
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Actual
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Date of last data collection
Anticipated
31/10/2022
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Actual
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Sample size
Target
70
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Accrual to date
26
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [2]
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Sydney Children's Hospital - Randwick
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Recruitment postcode(s) [1]
28590
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2145 - Westmead
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Recruitment postcode(s) [2]
28591
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2031 - Randwick
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Academic Department of Adolescent Medicine, The Children's Hospital at Westmead
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Address [1]
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The Children's Hospital at Westmead, Corner Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145.
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Agency for Clinical Innovation (ACI)
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Address [2]
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Level 4, 67 Albert Avenue
Chatswood
NSW 2067
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Country [2]
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Australia
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Primary sponsor type
Individual
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Name
Professor Katharine Steinbeck
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Address
The Academic Department of Adolescent Medicine,
The Children's Hospital at Westmead.
Cnr Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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The Academic Department of Adolescent Medicine, The Children's Hospital at Westmead
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Address [1]
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Corner Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
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Country [1]
304823
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Children’s Hospitals Network Human Research Ethics Committee
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Ethics committee address [1]
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Corner Hawkesbury Road
and Hainsworth Street
Research Ethics Office
Locked Bag 4001
Westmead NSW 2145
Sydney Australia
DX 8213 Parramatta
Tel +61 2 9845 0000
Fax +61 2 9845 3489
http://www.schn.health.nsw.gov.au/
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Ethics committee country [1]
303096
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Australia
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Date submitted for ethics approval [1]
303096
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27/09/2017
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Approval date [1]
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08/11/2017
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Ethics approval number [1]
303096
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HREC/17/SCHN/385
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Summary
Brief summary
Mobile technology has been proposed as an innovative opportunity to assist in improving the management of chronic illnesses as young people transition to adult care services. The TransitionMate study is the first trial that we can identify of a generic mobile application for the self-management of a cohort of adolescents with chronic illnesses transitioning from paediatric to adult care services. It is a two centre, pragmatic, single arm, mixed methods cohort study conducted within two University Teaching Paediatric Hospitals in Sydney, Australia.
We hypothesis that use of the TransitionMate mobile application will result in improved engagement and retention of adolescents with chronic illness within adult services as well as reduce deterioration in illness control and unplanned hospitalisations.e with chronic illness in their transition from paediatric to adult health care services.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Katharine Steinbeck
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Address
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Professor Kate Steinbeck MBBS PhD FRACP
Director | WH&Y, NHMRC Centre of Research Excellence in Adolescent Health
Medical Foundation Chair in Adolescent Medicine
Discipline of Child and Adolescent Health | The University of Sydney
Academic Department of Adolescent Medicine, Level 1, The Children’s Hospital at Westmead.
Corner Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
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Country
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Australia
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Phone
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+61 298452507
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Miss Tina Cunningham
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Address
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Tina Cunningham | Research Executive Assistant to Professor Kate Steinbeck, Medical Foundation Chair in Adolescent Medicine | Discipline of Child and Adolescent Health, University of Sydney.
The Academic Department of Adolescent Medicine, The Children’s Hospital at Westmead,
Corner Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
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Country
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Australia
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Phone
92455
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+61 298452507
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Katharine Steinbeck
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Address
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Professor Kate Steinbeck MBBS PhD FRACP
Director | WH&Y, NHMRC Centre of Research Excellence in Adolescent Health
Medical Foundation Chair in Adolescent Medicine
Discipline of Child and Adolescent Health | The University of Sydney
The Academic Department of Adolescent Medicine, Level 1, The Children’s Hospital at Westmead.
Corner Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145.
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Country
92456
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Australia
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Phone
92456
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+61 298452507
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Fax
92456
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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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