Healthcare Transition of Adolescents With Chronic Health Conditions

• Conditions: Transition; Kidney Diseases; Rheumatic Diseases; Liver Diseases; Congenital Heart Disease; Inflammatory Bowel Diseases; Neurologic Disorder; Diabetes
• Interventions: Behavioral: Transition support service

• Registration Number: NCT04631965
• Lead Sponsor: University of Helsinki

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-17
• Status Verified: 2021-12
• Primary Completion: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 503

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort in Australia	Transition support service	250 young patients who attend clinics in Victoria, Australia and who have received support from a hospital-wide transition support service

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in employment status	Baseline to two years post-transfer	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.
Change in educational status	Baseline to two years post-transfer	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.

Trial Locations

Locations (2)

Royal Children's Hospital; 🇦🇺 Melbourne, Victoria, Australia

Pediatric Research Center; 🇫🇮 Helsinki, Uusimaa, Finland