Healthcare Transition of Adolescents With Chronic Health Conditions

• ClinicalTrials.gov Identifier: NCT04631965
• Recruitment Status: Active, not recruiting
• First Posted: November 17, 2020
• Last Update Posted: December 21, 2021
• Sponsor: University of Helsinki
• Collaborators: Pediatric Research Center; Foundation for Medical Research; Foundation for Paediatric Research, Finland; The Paulo Foundation; Royal Children's Hospital; Murdoch Childrens Research Institute; University of Melbourne
• Information provided by (Responsible Party): Silja Kosola, MD PhD, University of Helsinki

Study Description

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.

Condition or disease	Intervention/treatment
Transition; Diabetes; Kidney Diseases; Liver Diseases; Inflammatory Bowel Diseases; Rheumatic Diseases; Congenital Heart Disease; Neurologic Disorder	Behavioral: Transition support service

Study Design

• Study Type: Observational
• Actual Enrollment: 503 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Bridge: an International Longitudinal Study of Healthcare Transition of Adolescents With Severe Chronic Health Conditions
• Actual Study Start Date: September 1, 2017
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2023

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Other Outcome Measures:

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 20 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

Australia, Victoria

Royal Children's Hospital

Melbourne, Victoria, Australia, 3052

Finland

Pediatric Research Center

Helsinki, Uusimaa, Finland, 00029

Sponsors and Collaborators

University of Helsinki

Pediatric Research Center

Foundation for Medical Research

Foundation for Paediatric Research, Finland

The Paulo Foundation

Royal Children's Hospital

Murdoch Childrens Research Institute

University of Melbourne

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Silja Kosola, MD PhD, Adjunct professor in Adolescent Medicine, University of Helsinki
• ClinicalTrials.gov Identifier: NCT04631965
• Other Study ID Numbers: U1011SILTA
• First Posted: November 17, 2020
• Last Update Posted: December 21, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Only collated data may be shared according to EU and Commonwealth data protection requirements.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Silja Kosola, MD PhD, University of Helsinki:

adolescent

Additional relevant MeSH terms:

Rheumatic Diseases; Liver Diseases; Inflammatory Bowel Diseases; Nervous System Diseases; Kidney Diseases; Heart Diseases; Heart Defects, Congenital; Collagen Diseases; Urologic Diseases; Cardiovascular Diseases; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Gastroenteritis; Cardiovascular Abnormalities; Congenital Abnormalities; Musculoskeletal Diseases; Connective Tissue Diseases