Clinical trial NCT04631965: Healthcare Transition of Adolescents With Chronic Health Conditions
Official title: Bridge: an International Longitudinal Study of Healthcare Transition of Adolescents With Severe Chronic Health Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transition
Diabetes
Kidney Diseases
Liver Diseases
Inflammatory Bowel Diseases
Rheumatic Diseases
Congenital Heart Disease
Neurologic Disorder
Keywords: adolescent
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Pediatric Research Center
name: Foundation for Medical Research
name: Foundation for Paediatric Research, Finland
name: The Paulo Foundation
name: Royal Children's Hospital
name: Murdoch Childrens Research Institute
name: University of Melbourne
First posted: 2020-11-17
Enrollment: 503
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Researchers approached all eligible patients until 250 patients at both study sites were recruited. According to power calculations, this will be sufficient to have a 90% chance of detecting, as significant at the 5% level, a 5% change in quality of life, even if groups differ in size.

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.


Eligibility criteria: 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

Exclusion Criteria:

* Lack of fluency in study languages (Finnish, Swedish and English)
* Cognitive limitations that inhibit responding to questionnaires

Primary outcomes:
measure: Change in 16D health-related quality of life
timeFrame: Baseline to two years post-transfer
measure: Change in PedsQL health-related quality of life
timeFrame: Baseline to two years post-transfer
measure: Change in health status
timeFrame: Baseline to two years post-transfer
measure: Change in anxiety related to transition of care
timeFrame: Baseline to two years post-transfer
measure: Missed appointments
timeFrame: Two years post-transfer
measure: Emergency admissions
timeFrame: Two years post-transfer
Secondary outcomes:
measure: Change in educational status
timeFrame: Baseline to two years post-transfer
measure: Change in employment status
timeFrame: Baseline to two years post-transfer
Other outcomes:
measure: Adolescent-friendliness of healthcare services in pediatric and adult hospitals
timeFrame: Baseline to two years post-transfer
Locations:
city: Melbourne
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Helsinki
country: Finland
facility: Pediatric Research Center
state: Uusimaa
Study officials:
References:
citation: 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.