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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04631965




Registration number
NCT04631965
Ethics application status
Date submitted
21/10/2020
Date registered
17/11/2020

Titles & IDs
Public title
Healthcare Transition of Adolescents With Chronic Health Conditions
Scientific title
Bridge: an International Longitudinal Study of Healthcare Transition of Adolescents With Severe Chronic Health Conditions
Secondary ID [1] 0 0
U1011SILTA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transition 0 0
Diabetes 0 0
Kidney Diseases 0 0
Liver Diseases 0 0
Inflammatory Bowel Diseases 0 0
Rheumatic Diseases 0 0
Congenital Heart Disease 0 0
Neurologic Disorder 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
BEHAVIORAL - Transition support service

Cohort in Finland - 253 young patients who attend clinics in Finland with no hospital-wide transition support service available

Cohort in Australia - 250 young patients who attend clinics in Victoria, Australia and who have received support from a hospital-wide transition support service


BEHAVIORAL: Transition support service
The hospital-wide transition support service provides systematic care coordination for young patients prior to the transfer of care
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in 16D health-related quality of life
Timepoint [1] 0 0
Baseline to two years post-transfer
Primary outcome [2] 0 0
Change in PedsQL health-related quality of life
Timepoint [2] 0 0
Baseline to two years post-transfer
Primary outcome [3] 0 0
Change in health status
Timepoint [3] 0 0
Baseline to two years post-transfer
Primary outcome [4] 0 0
Change in anxiety related to transition of care
Timepoint [4] 0 0
Baseline to two years post-transfer
Primary outcome [5] 0 0
Missed appointments
Timepoint [5] 0 0
Two years post-transfer
Primary outcome [6] 0 0
Emergency admissions
Timepoint [6] 0 0
Two years post-transfer
Secondary outcome [1] 0 0
Change in educational status
Timepoint [1] 0 0
Baseline to two years post-transfer
Secondary outcome [2] 0 0
Change in employment status
Timepoint [2] 0 0
Baseline to two years post-transfer

Eligibility
Key inclusion criteria
* Adolescents with a chronic medical condition (duration at least 6 months prior to recruitment)
* Attend care and/or follow-up at either the New Children's Hospital in Helsinki, Finland or the Royal Children's Hospital in Melbourne, Australia in one or more of the following disciplines: endocrinology, gastroenterology, cardiology, rheumatology, neurology, pediatric surgery, nephrology and solid organ transplantation.
* Care to be transferred to adult services within 0-12 months following recruitment
Minimum age
15 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Lack of fluency in study languages (Finnish, Swedish and English)
* Cognitive limitations that inhibit responding to questionnaires

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
Accrual to date
Final
503
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Uusimaa

Funding & Sponsors
Primary sponsor type
Other
Name
University of Helsinki
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Pediatric Research Center
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Foundation for Medical Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Foundation for Paediatric Research, Finland
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Paulo Foundation
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Royal Children's Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Murdoch Childrens Research Institute
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University of Melbourne
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only collated data may be shared according to EU and Commonwealth data protection requirements.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04631965