Congenital Heart DiseaseNCT02675361
Effectiveness of a Transition Program for Adolescents With Congenital Heart Disease in the Transition to Adulthood
A study testing Transition program in people with Congenital Heart Disease, run by Göteborg University at 7 sites in Sweden.
Trial summary
This study is part of a larger research project known as Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES). This project was created to develop and evaluate transition programs in order to support adolescents with chronic conditions in Sweden. Read more about this study
- Who is it for?
- Ages 16 to 16 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Transition program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 7 sitesSweden
- Study dates
- 1 Jul 2016to 30 Jun 2021
- Phase
- Interventional
- 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 16 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Literate
- Swedish-speaking
- Diagnosed with a congenital heart disease
- Age: 16 years
Who cannot join
- Syndromes affecting cognitive abilities
- Acquired heart diseases
- Heart transplantation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Children's Heart Center, Queen Silvia Children and Youth Hospital
Gothenburg, 416 85
Children Outpatient Clinic, Linköping University Hospital
Linköping, 581 85
Children's Heart Center, Skåne University Hospital
Lund, 221 85
Child and Adolescent Clinic, Örebro University Hospital
Örebro, 701 85
Children's Outpatient Cardiology Clinic, Astrid Lindgrens Children's Hospital
Stockholm, 171 76
Children's Outpatient Cardiology Clinic, Norrland University Hospital
Umeå, 901 85
Children's Outpatient Cardiology Clinic, Academic Children's Hospital
Uppsala, 751 85
About this study
Official title: Effectiveness of a Transition Program to Empower Adolescents With Congenital Heart Disease in the Transition to Adulthood: the STEPSTONES Project
This study is part of a larger research project known as Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES). This project was created to develop and evaluate transition programs in order to support adolescents with chronic conditions in Sweden. While STEPSTONES has a generic nature, the first transition program that will be evaluated targets adolescents with congenital heart disease (ConHD).
This particular study involves a hybrid experimental design, meaning a randomized controlled trial is embedded in a longitudinal, observational study. This type of design will help to test the effectiveness of a transition program in order to empower adolescents with congenital heart disease in the transition to adulthood and check for potential contamination of the comparison group. We will recruit 210 participants: 140 adolescents will be part of the randomized controlled trial (70 in the intervention arm; 70 in the comparison arm), and 70 participants will be assigned to the observational, longitudinal arm of the study, which serves as control group in an intervention-naive center. Over a period of two years, three assessments will be done during which all participants will be asked to answer a set of questionnaires.
The intervention to be tested involves patient empowerment, education on their ConHD, dealing with school, health behaviors required to maintain good health, guidance of parents, a person-centered transition plan, among others. The study hypothesis is that adolescents with ConHD who received a structured, person-centered transition program over a 2-year period have a higher patient empowerment score than adolescents who receive usual care.
Read the detailed description
Congenital heart diseases (ConHD) represent 28% of all congenital abnormalities.This population has experienced an increased life expectancy due to improvements in medical services and surgical techniques. Currently, around 90% of them will reach adulthood. Due to the complexity of these disorders, children with ConHD have to be under continuing follow-up. However, when they reach 18 years, they will be transferred to adult care. In order to help the adolescent in the transitions to adulthood and adult care, transitions programs have been proposed as a complex intervention with the objective of maximizing lifelong functioning and potential through appropriate healthcare services.
Patient empowerment is recognized as an essential element of transition interventions.Through the promotion of patient empowerment the adolescents can become active partners in their care and have the knowledge and capacity to make decisions that affect their life and health status.
While the importance of transition programs has been mentioned previously, high level evidence on the effectiveness of these interventions is limited. The purpose of this study is to assess the effectiveness of a transition program for adolescents with congenital heart disease. In order to asses the effectiveness of the transition program the investigators proposed a hybrid experimental design where a randomized controlled trial is embedded in a longitudinal, observational study.
During the course of the study, participants will be part of a transition program or receive usual care before being transferred to adult care. The primary outcome is level of empowerment and secondary outcomes include patient-reported health, illness perception, quality of life, health behaviors, knowledge on congenital heart disease, transition readiness, parental uncertainty and parenting.
The investigators will assess the effectiveness of the transition program by comparing the level of empowerment between the participants who received usual care and those who participated in the transition program. A higher level of empowerment from the group part of the intervention it's expected.
A process and economic evaluation of the intervention will also be undertaken. The process evaluation will evaluate the process of care delivery within the transition program. This information will helped describe the mechanism of impact, explore potential expansion to other chronic conditions and to prepare permanent implementation of the transition program in Sweden.
The economic evaluation entails an impact budget assessment and a cost-effectiveness analysis.
- Conditions
- Congenital Heart Disease
- Being tested
- Transition program
- Keywords
- Transfer to adult care, Continuity of patient care, Transition program
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition programBehavioural
Participants will be part of a transition program with eight key components: 1. A transition coordinator; 2. Education on congenital heart disease (CHD), treatments, health behavior, dealing with school, friends; 3. Telephone availability; 4. Information about the Grown-Up Congenital Heart Disease (GUCH) program: 5. Guidance of parents; 6. Meeting with peers: 7. A person-centered transition plan; and 8. Transfer to Grown-Up Congenital Heart Disease clinic. The intervention will be implemented by specialized nurses at the outpatient clinic of pediatric cardiology. Overall, 60 to 90 minutes per patient are spent over the 2.5 years.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: transition program | Experimental | Participants come from two clinics and will be randomly allocated to this group. Participants will go through a transition program which will last for 2 years. The intervention will be performed by specialist nurses. Receives: Behavioral: Transition program |
| Comparison group | No intervention | Participants allocated to this group will receive usual care, which includes follow-up visits according to the complexity of the congenital heart disease. Usual care can vary across clinics, however, they all include meeting with a nurse and a physician. This is established as a comparison group since there is the risk of contamination in this group. |
| Control group | No intervention | Participants in this group will receive usual care. Follow-up visits will depend on the complexity of the disease. Five clinis comprise this section of the study and will be part of an longitudinal, observational study, which investigators will use as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of empowerment
Gothenburg Young Persons Empowerment Scale (GYPES) will be used to assess the level of empowerment. This scale was developed by the researchers involved in this study and has been tested in a previous cross sectional study in order to determine its psychometric properties in adolescents with congenital heart disease. The investigators will compare the level of empowerment between groups before and after the transfer of care. Empowerment level will be measured at three different points, when the participants are 16 (baseline), 17 (midterm) and 18 years old (after transfer).
Measured: Three measurements over a 2-year period.
Secondary outcomes (7)
Transition readiness
Readiness for transition questionnaire (adolescent version)
Measured: Three measurements over a 2-year period.
Knowledge
Knowledge scale for adults with congenital malformed hearts
Measured: Three measurements over a 2-year period.
Health behavior
Health behavior scale-congenital heart disease
Measured: Three measurements over a 2-year period.
Patient reported health I
Questionnaire (PedsQL 4.0) (generic and cardiac module)
Measured: Three measurements over a 2-year period.
Quality of life
Linear analog scale
Measured: Three measurements over a 2-year period.
Patient reported health II
Questionnaire (EQ-5D-3L)
Measured: Three measurements over a 2-year period.
Healthcare utilization
Healthcare utilization questionnaire
Measured: Three measurements over a 2-year period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Swedish Children Heart Association, The Swedish Research Council, Sahlgrenska University Hospital, Skane University Hospital, Norrlands University Hospital, Karolinska University Hospital, Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
- Investigators
- Philip Moons, Principal investigator, University of Gothenburg and KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675361
- Sponsor's protocol ID
- STEPSTONES-ConHD
- Status last verified
- Jun 2021
- First submitted
- 2 Feb 2016
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Coded files will be available only for research purposes. Information will be given after a letter with the intention of the study has been submitted to the Steering Committee who will determine whether to approve or deny the application.
Publications
Hilderson D, Moons P, Van der Elst K, Luyckx K, Wouters C, Westhovens R. The clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: results of the DON'T RETARD project. Rheumatology (Oxford). 2016 Jan;55(1):133-42. doi: 10.1093/rheumatology/kev284. Epub 2015 Aug 28.
PubMed 26320142Hilderson D, Westhovens R, Wouters C, Van der Elst K, Goossens E, Moons P. Rationale, design and baseline data of a mixed methods study examining the clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: the DON'T RETARD project. BMJ Open. 2013 Dec 2;3(12):e003591. doi: 10.1136/bmjopen-2013-003591.
PubMed 24302502Knauth Meadows A, Bosco V, Tong E, Fernandes S, Saidi A. Transition and transfer from pediatric to adult care of young adults with complex congenital heart disease. Curr Cardiol Rep. 2009 Jul;11(4):291-7. doi: 10.1007/s11886-009-0042-8.
PubMed 19563729Moons P, Bovijn L, Budts W, Belmans A, Gewillig M. Temporal trends in survival to adulthood among patients born with congenital heart disease from 1970 to 1992 in Belgium. Circulation. 2010 Nov 30;122(22):2264-72. doi: 10.1161/CIRCULATIONAHA.110.946343. Epub 2010 Nov 22.
PubMed 21098444McDonagh JE, Kelly DA. The challenges and opportunities for transitional care research. Pediatr Transplant. 2010 Sep 1;14(6):688-700. doi: 10.1111/j.1399-3046.2010.01343.x. Epub 2010 Jun 17.
PubMed 20557475Small N, Bower P, Chew-Graham CA, Whalley D, Protheroe J. Patient empowerment in long-term conditions: development and preliminary testing of a new measure. BMC Health Serv Res. 2013 Jul 8;13:263. doi: 10.1186/1472-6963-13-263.
PubMed 23835131Sable C, Foster E, Uzark K, Bjornsen K, Canobbio MM, Connolly HM, Graham TP, Gurvitz MZ, Kovacs A, Meadows AK, Reid GJ, Reiss JG, Rosenbaum KN, Sagerman PJ, Saidi A, Schonberg R, Shah S, Tong E, Williams RG; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Best practices in managing transition to adulthood for adolescents with congenital heart disease: the transition process and medical and psychosocial issues: a scientific statement from the American Heart Association. Circulation. 2011 Apr 5;123(13):1454-85. doi: 10.1161/CIR.0b013e3182107c56. Epub 2011 Feb 28. No abstract available.
PubMed 21357825Malmesjo H, Mora MA, Bratt EL, Sparud-Lundin C, Moons P, Saarijarvi M. Transition readiness in adolescents with congenital heart disease during transfer to adult care: A secondary analysis of the STEPSTONES randomized controlled trial. Health Care Transit. 2026 Oct 13;4:100154. doi: 10.1016/j.hctj.2026.100154. eCollection 2026.
PubMed 42936327Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
PubMed 39382077Bratt EL, Mora MA, Sparud-Lundin C, Saarijarvi M, Burstrom A, Skogby S, Fernlund E, Fadl S, Rydberg A, Hanseus K, Kazamia K, Moons P. Effectiveness of the STEPSTONES Transition Program for Adolescents With Congenital Heart Disease-A Randomized Controlled Trial. J Adolesc Health. 2023 Oct;73(4):655-663. doi: 10.1016/j.jadohealth.2023.02.019. Epub 2023 Apr 8.
PubMed 37032211Acuna Mora M, Sparud-Lundin C, Bratt EL, Moons P. Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project). BMJ Open. 2017 Apr 17;7(4):e014593. doi: 10.1136/bmjopen-2016-014593.
PubMed 28420661
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Transition Program to Empower Adolescents With Congenital Heart Disease in the Transition to Adulthood: the STEPSTONES Project
- ClinicalTrials.gov ID
- NCT02675361
- Acronym / sponsor ID
- STEPSTONES-ConHD
- Conditions
- Congenital Heart Disease
- Keywords
- Transfer to adult care, Continuity of patient care, Transition program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Swedish Children Heart Association, The Swedish Research Council, Sahlgrenska University Hospital, Skane University Hospital, Norrlands University Hospital, Karolinska University Hospital, Swedish Council for Working Life and Social Research
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Feb 2016 (estimated)
- 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.
This study is part of a larger research project known as Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES). This project was created to develop and evaluate transition programs in order to support adolescents with chronic conditions in Sweden. While STEPSTONES has a generic nature, the first transition program that will be evaluated targets adolescents with congenital heart disease (ConHD).
This particular study involves a hybrid experimental design, meaning a randomized controlled trial is embedded in a longitudinal, observational study. This type of design will help to test the effectiveness of a transition program in order to empower adolescents with congenital heart disease in the transition to adulthood and check for potential contamination of the comparison group. We will recruit 210 participants: 140 adolescents will be part of the randomized controlled trial (70 in the intervention arm; 70 in the comparison arm), and 70 participants will be assigned to the observational, longitudinal arm of the study, which serves as control group in an intervention-naive center. Over a period of two years, three assessments will be done during which all participants will be asked to answer a set of questionnaires.
The intervention to be tested involves patient empowerment, education on their ConHD, dealing with school, health behaviors required to maintain good health, guidance of parents, a person-centered transition plan, among others. The study hypothesis is that adolescents with ConHD who received a structured, person-centered transition program over a 2-year period have a higher patient empowerment score than adolescents who receive usual care.
Detailed description
Congenital heart diseases (ConHD) represent 28% of all congenital abnormalities.This population has experienced an increased life expectancy due to improvements in medical services and surgical techniques. Currently, around 90% of them will reach adulthood. Due to the complexity of these disorders, children with ConHD have to be under continuing follow-up. However, when they reach 18 years, they will be transferred to adult care. In order to help the adolescent in the transitions to adulthood and adult care, transitions programs have been proposed as a complex intervention with the objective of maximizing lifelong functioning and potential through appropriate healthcare services.
Patient empowerment is recognized as an essential element of transition interventions.Through the promotion of patient empowerment the adolescents can become active partners in their care and have the knowledge and capacity to make decisions that affect their life and health status.
While the importance of transition programs has been mentioned previously, high level evidence on the effectiveness of these interventions is limited. The purpose of this study is to assess the effectiveness of a transition program for adolescents with congenital heart disease. In order to asses the effectiveness of the transition program the investigators proposed a hybrid experimental design where a randomized controlled trial is embedded in a longitudinal, observational study.
During the course of the study, participants will be part of a transition program or receive usual care before being transferred to adult care. The primary outcome is level of empowerment and secondary outcomes include patient-reported health, illness perception, quality of life, health behaviors, knowledge on congenital heart disease, transition readiness, parental uncertainty and parenting.
The investigators will assess the effectiveness of the transition program by comparing the level of empowerment between the participants who received usual care and those who participated in the transition program. A higher level of empowerment from the group part of the intervention it's expected.
A process and economic evaluation of the intervention will also be undertaken. The process evaluation will evaluate the process of care delivery within the transition program. This information will helped describe the mechanism of impact, explore potential expansion to other chronic conditions and to prepare permanent implementation of the transition program in Sweden.
The economic evaluation entails an impact budget assessment and a cost-effectiveness analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group: transition program | Experimental | Behavioral: Transition programParticipants come from two clinics and will be randomly allocated to this group. Participants will go through a transition program which will last for 2 years. The intervention will be performed by specialist nurses. |
| Comparison group | No intervention | –Participants allocated to this group will receive usual care, which includes follow-up visits according to the complexity of the congenital heart disease. Usual care can vary across clinics, however, they all include meeting with a nurse and a physician. This is established as a comparison group since there is the risk of contamination in this group. |
| Control group | No intervention | –Participants in this group will receive usual care. Follow-up visits will depend on the complexity of the disease. Five clinis comprise this section of the study and will be part of an longitudinal, observational study, which investigators will use as a control group. |
Who may qualify
- Ages
- 16 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Literate
- Swedish-speaking
- Diagnosed with a congenital heart disease
- Age: 16 years
Key exclusion criteria (3 listed)
- Syndromes affecting cognitive abilities
- Acquired heart diseases
- Heart transplantation
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 programParticipants will be part of a transition program with eight key components: 1. A transition coordinator; 2. Education on congenital heart disease (CHD), treatments, health behavior, dealing with school, friends; 3. Telephone availability; 4. Information about the Grown-Up Congenital Heart Disease (GUCH) program: 5. Guidance of parents; 6. Meeting with peers: 7. A person-centered transition plan; and 8. Transfer to Grown-Up Congenital Heart Disease clinic. The intervention will be implemented by specialized nurses at the outpatient clinic of pediatric cardiology. Overall, 60 to 90 minutes per patient are spent over the 2.5 years. | Behavioural | Intervention group: transition program |
Primary outcome
Level of empowerment
Time frame: Three measurements over a 2-year period.
Gothenburg Young Persons Empowerment Scale (GYPES) will be used to assess the level of empowerment. This scale was developed by the researchers involved in this study and has been tested in a previous cross sectional study in order to determine its psychometric properties in adolescents with congenital heart disease. The investigators will compare the level of empowerment between groups before and after the transfer of care. Empowerment level will be measured at three different points, when the participants are 16 (baseline), 17 (midterm) and 18 years old (after transfer).
7 secondary outcomes
Transition readiness
Time frame: Three measurements over a 2-year period.
Knowledge
Time frame: Three measurements over a 2-year period.
Health behavior
Time frame: Three measurements over a 2-year period.
Patient reported health I
Time frame: Three measurements over a 2-year period.
Quality of life
Time frame: Three measurements over a 2-year period.
Patient reported health II
Time frame: Three measurements over a 2-year period.
Healthcare utilization
Time frame: Three measurements over a 2-year period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Background: PubMed 26320142Hilderson D, Moons P, Van der Elst K, Luyckx K, Wouters C, Westhovens R. The clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: results of the DON'T RETARD project. Rheumatology (Oxford). 2016 Jan;55(1):133-42. doi: 10.1093/rheumatology/kev284. Epub 2015 Aug 28.
- Background: PubMed 24302502Hilderson D, Westhovens R, Wouters C, Van der Elst K, Goossens E, Moons P. Rationale, design and baseline data of a mixed methods study examining the clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: the DON'T RETARD project. BMJ Open. 2013 Dec 2;3(12):e003591. doi: 10.1136/bmjopen-2013-003591.
- Background: PubMed 19563729Knauth Meadows A, Bosco V, Tong E, Fernandes S, Saidi A. Transition and transfer from pediatric to adult care of young adults with complex congenital heart disease. Curr Cardiol Rep. 2009 Jul;11(4):291-7. doi: 10.1007/s11886-009-0042-8.
- Background: PubMed 21098444Moons P, Bovijn L, Budts W, Belmans A, Gewillig M. Temporal trends in survival to adulthood among patients born with congenital heart disease from 1970 to 1992 in Belgium. Circulation. 2010 Nov 30;122(22):2264-72. doi: 10.1161/CIRCULATIONAHA.110.946343. Epub 2010 Nov 22.
- Background: PubMed 20557475McDonagh JE, Kelly DA. The challenges and opportunities for transitional care research. Pediatr Transplant. 2010 Sep 1;14(6):688-700. doi: 10.1111/j.1399-3046.2010.01343.x. Epub 2010 Jun 17.
- Background: PubMed 23835131Small N, Bower P, Chew-Graham CA, Whalley D, Protheroe J. Patient empowerment in long-term conditions: development and preliminary testing of a new measure. BMC Health Serv Res. 2013 Jul 8;13:263. doi: 10.1186/1472-6963-13-263.
- Background: PubMed 21357825Sable C, Foster E, Uzark K, Bjornsen K, Canobbio MM, Connolly HM, Graham TP, Gurvitz MZ, Kovacs A, Meadows AK, Reid GJ, Reiss JG, Rosenbaum KN, Sagerman PJ, Saidi A, Schonberg R, Shah S, Tong E, Williams RG; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Best practices in managing transition to adulthood for adolescents with congenital heart disease: the transition process and medical and psychosocial issues: a scientific statement from the American Heart Association. Circulation. 2011 Apr 5;123(13):1454-85. doi: 10.1161/CIR.0b013e3182107c56. Epub 2011 Feb 28. No abstract available.
- Derived from this study: PubMed 42936327Malmesjo H, Mora MA, Bratt EL, Sparud-Lundin C, Moons P, Saarijarvi M. Transition readiness in adolescents with congenital heart disease during transfer to adult care: A secondary analysis of the STEPSTONES randomized controlled trial. Health Care Transit. 2026 Oct 13;4:100154. doi: 10.1016/j.hctj.2026.100154. eCollection 2026.
- Derived from this study: PubMed 39382077Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
- Derived from this study: PubMed 37032211Bratt EL, Mora MA, Sparud-Lundin C, Saarijarvi M, Burstrom A, Skogby S, Fernlund E, Fadl S, Rydberg A, Hanseus K, Kazamia K, Moons P. Effectiveness of the STEPSTONES Transition Program for Adolescents With Congenital Heart Disease-A Randomized Controlled Trial. J Adolesc Health. 2023 Oct;73(4):655-663. doi: 10.1016/j.jadohealth.2023.02.019. Epub 2023 Apr 8.
- Derived from this study: PubMed 28420661Acuna Mora M, Sparud-Lundin C, Bratt EL, Moons P. Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project). BMJ Open. 2017 Apr 17;7(4):e014593. doi: 10.1136/bmjopen-2016-014593.
- Individual participant dataSharing planned: Yes. Coded files will be available only for research purposes. Information will be given after a letter with the intention of the study has been submitted to the Steering Committee who will determine whether to approve or deny the application.
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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.
Philip Moons principal investigator
University of Gothenburg and KU Leuven
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition program in people with Congenital Heart Disease, run by Göteborg University at 7 sites in Sweden.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of empowerment (time frame: Three measurements over a 2-year period.). 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 NCT02675361, which also lists 11 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 2 Jul 2021.