Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Titles & IDs
Public title
Healthcare Transition of Adolescents With Chronic Health Conditions
Query!
Scientific title
Bridge: an International Longitudinal Study of Healthcare Transition of Adolescents With Severe Chronic Health Conditions
Query!
Secondary ID [1]
0
0
U1011SILTA
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Transition
0
0
Query!
Diabetes
0
0
Query!
Kidney Diseases
0
0
Query!
Liver Diseases
0
0
Query!
Inflammatory Bowel Diseases
0
0
Query!
Rheumatic Diseases
0
0
Query!
Congenital Heart Disease
0
0
Query!
Neurologic Disorder
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Cancer
0
0
0
0
Query!
Liver
Query!
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Intervention code [1]
0
0
BEHAVIORAL
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in 16D health-related quality of life
Query!
Assessment method [1]
0
0
16D is a generic, validated self-report of health related quality of life (HRQoL). It has 16 dimensions, all rated on a 5-point Likert scale. The total 16D score varies from 0 to 1, with 1 being the best imaginable state of HRQoL and with a minimum important change of 0.015.
Query!
Timepoint [1]
0
0
Baseline to two years post-transfer
Query!
Primary outcome [2]
0
0
Change in PedsQL health-related quality of life
Query!
Assessment method [2]
0
0
The Pediatric Quality of Life Inventory (PedsQL) is another validated generic tool to measure HRQoL. It includes 25 questions divided into 4 categories (physical, emotional, social and school). Scores range from 0 to 100, with 100 the best imaginable HRQoL.
Query!
Timepoint [2]
0
0
Baseline to two years post-transfer
Query!
Primary outcome [3]
0
0
Change in health status
Query!
Assessment method [3]
0
0
Patients will report on their symptom severity during the past week using the Visual Analog Scale (VAS). The VAS is a line, 10cm long, with worst imaginable health at one end, and best imaginable health at the other end. Patients make a mark indicating their health between these.
Query!
Timepoint [3]
0
0
Baseline to two years post-transfer
Query!
Primary outcome [4]
0
0
Change in anxiety related to transition of care
Query!
Assessment method [4]
0
0
The State-Trait Anxiety Inventory (STAI) is a validated, 6-item self-report tool to measure anxiety. Items are rated on a 4-point Likert scale. Possible scores range between 20-80, with higher scores indicating higher anxiety.
Query!
Timepoint [4]
0
0
Baseline to two years post-transfer
Query!
Primary outcome [5]
0
0
Missed appointments
Query!
Assessment method [5]
0
0
Data linkage will be used to gather the number of missed appointments (uncancelled, not rescheduled) in adult health care. These will serve as one indicator of treatment adherence.
Query!
Timepoint [5]
0
0
Two years post-transfer
Query!
Primary outcome [6]
0
0
Emergency admissions
Query!
Assessment method [6]
0
0
Data linkage will be used to gather information on emergency admissions after the transfer of care. Admissions related to the respective chronic health conditions will serve as one indicator of treatment adherence.
Query!
Timepoint [6]
0
0
Two years post-transfer
Query!
Secondary outcome [1]
0
0
Change in educational status
Query!
Assessment method [1]
0
0
In a questionnaire, patients will annually report on their education status. (Specific question and response options: What is your current education status? Tick one: High school, University student, Homemaker or caregiver, Other (please specify), I'm not enrolled in any studies. These figures will be compared with respective national data.
Query!
Timepoint [1]
0
0
Baseline to two years post-transfer
Query!
Secondary outcome [2]
0
0
Change in employment status
Query!
Assessment method [2]
0
0
In a questionnaire, patients will annually report on their employment status. (Specific question and response options: What is your current employment status? Tick one: Working part-time (\<30 hours/week); Working full-time (incl. working in shifts); Unemployed, looking for work; Unemployed, not looking for work; Homemaker or caregiver; Other (please specify). These figures will be compared with respective national data.
Query!
Timepoint [2]
0
0
Baseline to two years post-transfer
Query!
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
Query!
Minimum age
15
Years
Query!
Query!
Maximum age
20
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Lack of fluency in study languages (Finnish, Swedish and English)
* Cognitive limitations that inhibit responding to questionnaires
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
UNKNOWN
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2023
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
503
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Royal Children's Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3052 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Finland
Query!
State/province [1]
0
0
Uusimaa
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Helsinki
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Pediatric Research Center
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Foundation for Medical Research
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Foundation for Paediatric Research, Finland
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
Query!
Name [4]
0
0
The Paulo Foundation
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Other collaborator category [5]
0
0
Other
Query!
Name [5]
0
0
Royal Children's Hospital
Query!
Address [5]
0
0
Query!
Country [5]
0
0
Query!
Other collaborator category [6]
0
0
Other
Query!
Name [6]
0
0
Murdoch Childrens Research Institute
Query!
Address [6]
0
0
Query!
Country [6]
0
0
Query!
Other collaborator category [7]
0
0
Other
Query!
Name [7]
0
0
University of Melbourne
Query!
Address [7]
0
0
Query!
Country [7]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04631965
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Only collated data may be shared according to EU and Commonwealth data protection requirements.
Query!
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