Healthcare Transition of Adolescents With Chronic Health Conditions

Study Overview
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Brief Summary
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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.

Official Title
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Bridge: an International Longitudinal Study of Healthcare Transition of Adolescents With Severe Chronic Health Conditions

Conditions
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Transition, Diabetes, Kidney Diseases, Liver Diseases, Inflammatory Bowel Diseases, Rheumatic Diseases, Congenital Heart Disease, Neurologic Disorder

Intervention / Treatment
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* Behavioral: Transition support service


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort in Finland<br>253 young patients who attend clinics in Finland with no hospital-wide transition support service available | |
| Cohort in Australia<br>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<br>* The hospital-wide transition support service provides systematic care coordination for young patients prior to the transfer of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 16D health-related quality of life | 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. | Baseline to two years post-transfer | 
| Change in PedsQL health-related quality of life | 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. | Baseline to two years post-transfer | 
| Change in health status | 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. | Baseline to two years post-transfer | 
| Change in anxiety related to transition of care | 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. | Baseline to two years post-transfer | 
| Missed appointments | 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. | Two years post-transfer | 
| Emergency admissions | 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. | Two years post-transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in educational status | 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. | Baseline to two years post-transfer | 
| Change in employment status | 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. | Baseline to two years post-transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent