Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
21/12/2021

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
At least 12% of children have a chronic disease that requires regular medical follow-up after patients reach legal maturity. This international study aims to provide prospective evidence for improving health and wellbeing outcomes in this population.

The primary hypothesis is that transition readiness will be more strongly associated with adherence to follow-up, fewer emergency visits and continued education than disease severity or chronological age.

The secondary hypothesis is that positive experiences of care will be associated with lower levels of anxiety. Positive care experiences and low anxiety will predict better health-related quality of life during the transition period.

A cohort of 504 young patients will be followed for three years. Patients have been recruited from pediatric hospitals 0-12 months prior to the transfer of care and follow-up will be completed after the patients have been followed for two years in adult healthcare.
Trial website
https://clinicaltrials.gov/study/NCT04631965
Trial related presentations / publications
Kosola S, Culnane E, Loftus H, Tornivuori A, Kallio M, Telfer M, Miettinen PJ, Kolho KL, Aalto K, Raivio T, Sawyer S. Bridge study protocol: an international, observational cohort study on the transition of healthcare for adolescents with chronic conditions. BMJ Open. 2021 Jun 21;11(6):e048340. doi: 10.1136/bmjopen-2020-048340.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04631965