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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
Scientific title
Transition Mate: A Mobile Phone App to Support Self-Management and Transition in Young People with Chronic Illness
Secondary ID [1] 297908 0
Nil
Universal Trial Number (UTN)
U1111-1231-3220
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic illnesses in Adolescents 312293 0
Transition of care 315244 0
Condition category
Condition code
Public Health 310846 310846 0 0
Health service research

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 316107 0
Prevention
Intervention code [2] 316108 0
Behaviour
Intervention code [3] 316109 0
Lifestyle
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
Control group
Historical

Outcomes
Primary outcome [1] 322006 0
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.
Timepoint [1] 322006 0
At 6 months, 12 months (primary endpoint) and 18 months after last clinic appointment at paediatric service.
Primary outcome [2] 322007 0
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.
Timepoint [2] 322007 0
At 6 months and 12 months (primary endpoint) after last clinic appointment at paediatric service.
Secondary outcome [1] 376985 0
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.
Timepoint [1] 376985 0
At 6 months and 12 months (primary endpoint) after last clinic appointment at paediatric service.

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
Minimum age
16 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/05/2019
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
31/10/2022
Actual
Sample size
Target
70
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15280 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 15281 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 28590 0
2145 - Westmead
Recruitment postcode(s) [2] 28591 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 302427 0
Hospital
Name [1] 302427 0
Academic Department of Adolescent Medicine, The Children's Hospital at Westmead
Country [1] 302427 0
Australia
Funding source category [2] 304546 0
Government body
Name [2] 304546 0
Agency for Clinical Innovation (ACI)
Country [2] 304546 0
Australia
Primary sponsor type
Individual
Name
Professor Katharine Steinbeck
Address
The Academic Department of Adolescent Medicine,
The Children's Hospital at Westmead.
Cnr Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 304823 0
Hospital
Name [1] 304823 0
The Academic Department of Adolescent Medicine, The Children's Hospital at Westmead
Address [1] 304823 0
Corner Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
Country [1] 304823 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303096 0
Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 303096 0
Ethics committee country [1] 303096 0
Australia
Date submitted for ethics approval [1] 303096 0
27/09/2017
Approval date [1] 303096 0
08/11/2017
Ethics approval number [1] 303096 0
HREC/17/SCHN/385

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

Contacts
Principal investigator
Name 92454 0
Prof Katharine Steinbeck
Address 92454 0
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
Country 92454 0
Australia
Phone 92454 0
+61 298452507
Fax 92454 0
Email 92454 0
kate.steinbeck@health.nsw.gov.au
Contact person for public queries
Name 92455 0
Tina Cunningham
Address 92455 0
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
Country 92455 0
Australia
Phone 92455 0
+61 298452507
Fax 92455 0
Email 92455 0
tina.cunningham@health.nsw.gov.au
Contact person for scientific queries
Name 92456 0
Katharine Steinbeck
Address 92456 0
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.
Country 92456 0
Australia
Phone 92456 0
+61 298452507
Fax 92456 0
Email 92456 0
kate.steinbeck@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.