Healthcare Transition of Adolescents With Chronic Health Conditions

December 20, 2021 updated by: Silja Kosola, MD PhD, University of Helsinki

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

503

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • Royal Children's Hospital
  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Pediatric Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adolescent-friendliness of healthcare services in pediatric and adult hospitals
Time Frame: Baseline to two years post-transfer
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1011SILTA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only collated data may be shared according to EU and Commonwealth data protection requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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