Healthcare Transition of Adolescents With Chronic Health Conditions

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04631965
• Other study ID #: U1011SILTA
• Status: Active, not recruiting
• Start date: September 1, 2017
• Est. completion date: December 2023

Study information

• Verified date: December 2021
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 503
• Est. completion date: December 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Congenital Heart Disease
• Diabetes
• Heart Defects, Congenital
• Heart Diseases
• Inflammatory Bowel Diseases
• Kidney Diseases
• Liver Diseases
• Nervous System Diseases
• Neurologic Disorder
• Rheumatic Diseases
• Transition

Intervention

Behavioral:
• Transition support service
The hospital-wide transition support service provides systematic care coordination for young patients prior to the transfer of care

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Melbourne	Victoria
Finland	Pediatric Research Center	Helsinki	Uusimaa

Sponsors (8)

Lead Sponsor	Collaborator
University of Helsinki	Foundation for Medical Research, Foundation for Paediatric Research, Finland, Murdoch Childrens Research Institute, Pediatric Research Center, Royal Children's Hospital, The Paulo Foundation, University of Melbourne

Countries where clinical trial is conducted

Australia,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adolescent-friendliness of healthcare services in pediatric and adult hospitals	Patients will evaluate the healthcare services they utilize using the Adolescent-friendly hospital survey that was developed in Melbourne in 2011. The survey includes eight items, with four response options each (I fully agree, I somewhat agree, I disagree and I don't know).	Baseline to two years post-transfer
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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