NCT04631965

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
503

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

4.3 years

First QC Date

October 21, 2020

Last Update Submit

December 20, 2021

Conditions

TransitionDiabetesKidney DiseasesLiver DiseasesInflammatory Bowel DiseasesRheumatic DiseasesCongenital Heart DiseaseNeurologic Disorder

Keywords

adolescent

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Change in educational status

    Baseline to two years post-transfer

  • Change in employment status

    Baseline to two years post-transfer

Other Outcomes (1)

  • Adolescent-friendliness of healthcare services in pediatric and adult hospitals

    Baseline to two years post-transfer

Study Arms (2)

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

Interventions

Transition support serviceBEHAVIORAL

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

Cohort in Australia

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Lack of fluency in study languages (Finnish, Swedish and English)
  • Cognitive limitations that inhibit responding to questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

Pediatric Research Center

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (5)

  • Alanen A, Kallio M, Culnane E, Koivisto M, Pasanen M, Salantera S, Sawyer S, Kosola S. Anxiety and care experiences in adolescents with chronic health conditions: an international, longitudinal study across the transfer of care. BMJ Paediatr Open. 2024 Nov 19;8(1):e002836. doi: 10.1136/bmjpo-2024-002836.

    PMID: 39566994DERIVED

  • Kallio MM, Tornivuori A, Kolho KL, Culnane E, Loftus H, Sawyer SM, Kosola S. Changes in health-related quality of life during transition to adult healthcare: an international prospective cohort study. Arch Dis Child. 2024 Jul 18;109(8):659-665. doi: 10.1136/archdischild-2024-327017.

    PMID: 38768988DERIVED

  • Kallio M, Tornivuori A, Miettinen PJ, Kolho KL, Relas H, Culnane E, Loftus H, Sawyer SM, Kosola S. Health-related quality of life and self-reported health status in adolescents with chronic health conditions before transfer of care to adult health care: an international cohort study. BMC Pediatr. 2024 Mar 8;24(1):163. doi: 10.1186/s12887-024-04629-x.

    PMID: 38459510DERIVED

  • Tornivuori A, Kallio M, Culnane E, Pasanen M, Salantera S, Sawyer S, Kosola S. Transition readiness and anxiety among adolescents with a chronic condition and their parents: A cross-sectional international study. J Adv Nurs. 2024 Feb;80(2):756-764. doi: 10.1111/jan.15860. Epub 2023 Sep 10.

    PMID: 37691321DERIVED

  • 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.

    PMID: 34155079DERIVED

MeSH Terms

Conditions

Diabetes MellitusKidney DiseasesLiver DiseasesInflammatory Bowel DiseasesRheumatic DiseasesHeart Defects, CongenitalNervous System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct professor in Adolescent Medicine

Study Record Dates

First Submitted

October 21, 2020

First Posted

November 17, 2020

Study Start

September 1, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2023

Last Updated

December 21, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

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

Locations

AU(1)FI(1)