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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
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.
Timepoint [1] 0 0
Baseline to two years post-transfer
Primary outcome [2] 0 0
Change in PedsQL health-related quality of life
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.
Timepoint [2] 0 0
Baseline to two years post-transfer
Primary outcome [3] 0 0
Change in health status
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.
Timepoint [3] 0 0
Baseline to two years post-transfer
Primary outcome [4] 0 0
Change in anxiety related to transition of care
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.
Timepoint [4] 0 0
Baseline to two years post-transfer
Primary outcome [5] 0 0
Missed appointments
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.
Timepoint [5] 0 0
Two years post-transfer
Primary outcome [6] 0 0
Emergency admissions
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.
Timepoint [6] 0 0
Two years post-transfer
Secondary outcome [1] 0 0
Change in educational status
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.
Timepoint [1] 0 0
Baseline to two years post-transfer
Secondary outcome [2] 0 0
Change in employment status
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.
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Pediatric Research Center
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Foundation for Medical Research
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Foundation for Paediatric Research, Finland
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Paulo Foundation
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Royal Children's Hospital
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Murdoch Childrens Research Institute
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University of Melbourne
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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