TransitionNCT04631965
Healthcare Transition of Adolescents With Chronic Health Conditions
An observational study of Transition and Diabetes, run by University of Helsinki at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Transition, Diabetes, Kidney Diseases
- What is being tested?
- Transition support service
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 503 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2017to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Lack of fluency in study languages (Finnish, Swedish and English)
- Cognitive limitations that inhibit responding to questionnaires
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read more
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.
- Conditions
- Transition, Diabetes, Kidney Diseases, Liver Diseases, Inflammatory Bowel Diseases, Rheumatic Diseases
- Being tested
- Transition support service
- Keywords
- adolescent
- Medical subject headings
- Diabetes Mellitus, Kidney Diseases, Liver Diseases, Inflammatory Bowel Diseases, Rheumatic Diseases, Heart Defects, Congenital, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition support serviceBehavioural
The hospital-wide transition support service provides systematic care coordination for young patients prior to the transfer of care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Transition support service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two years post-transfer
Secondary outcomes (2)
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.
Measured: Baseline to two years post-transfer
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.
Measured: Baseline to two years post-transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Sep 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for TransitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Silja Kosola, MD PhD, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631965
- Sponsor's protocol ID
- U1011SILTA
- Status last verified
- Dec 2021
- First submitted
- 21 Oct 2020
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only collated data may be shared according to EU and Commonwealth data protection requirements.
Publications
Alanen A, Kallio M, Salantera S, Kosola S. Young people with chronic health conditions: longitudinal study of psychosocial assessment and digital health service use across transfer of care. BMC Pediatr. 2026 Aug 8;26(1):1123. doi: 10.1186/s12887-026-07428-8.
PubMed 42983681Kallio M, Alanen A, Kolho KL, Relas H, Kosola S. Disease control, psychiatric comorbidity, health-related quality of life, and experiences of care during transition to adult healthcare: a single-center prospective study. Eur J Pediatr. 2026 Mar 11;185(4):174. doi: 10.1007/s00431-026-06791-z.
PubMed 41811518Alanen 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.
PubMed 39566994Kallio 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.
PubMed 38768988Kallio 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.
PubMed 38459510Tornivuori 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.
PubMed 37691321Kosola 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.
PubMed 34155079
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridge: an International Longitudinal Study of Healthcare Transition of Adolescents With Severe Chronic Health Conditions
- ClinicalTrials.gov ID
- NCT04631965
- Acronym / sponsor ID
- U1011SILTA
- Conditions
- Transition, Diabetes, Kidney Diseases, Liver Diseases, Inflammatory Bowel Diseases, Rheumatic Diseases
- Keywords
- adolescent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 503 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- 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
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort in Finland | – | –253 young patients who attend clinics in Finland with no hospital-wide transition support service available |
| Cohort in Australia | – | Behavioral: Transition support service250 young patients who attend clinics in Victoria, Australia and who have received support from a hospital-wide transition support service |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of fluency in study languages (Finnish, Swedish and English)
- Cognitive limitations that inhibit responding to questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition support serviceThe hospital-wide transition support service provides systematic care coordination for young patients prior to the transfer of care | Behavioural | Cohort in Australia |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Change in educational status
Time frame: Baseline to two years post-transfer
Change in employment status
Time frame: Baseline to two years post-transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Derived from this study: PubMed 42983681Alanen A, Kallio M, Salantera S, Kosola S. Young people with chronic health conditions: longitudinal study of psychosocial assessment and digital health service use across transfer of care. BMC Pediatr. 2026 Aug 8;26(1):1123. doi: 10.1186/s12887-026-07428-8.
- Derived from this study: PubMed 41811518Kallio M, Alanen A, Kolho KL, Relas H, Kosola S. Disease control, psychiatric comorbidity, health-related quality of life, and experiences of care during transition to adult healthcare: a single-center prospective study. Eur J Pediatr. 2026 Mar 11;185(4):174. doi: 10.1007/s00431-026-06791-z.
- Derived from this study: PubMed 39566994Alanen 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.
- Derived from this study: PubMed 38768988Kallio 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.
- Derived from this study: PubMed 38459510Kallio 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.
- Derived from this study: PubMed 37691321Tornivuori 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.
- Derived from this study: PubMed 34155079Kosola 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.
- Individual participant dataSharing planned: No. Only collated data may be shared according to EU and Commonwealth data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transition and Diabetes, run by University of Helsinki at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 16D health-related quality of life (time frame: Baseline to two years post-transfer). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04631965, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.