Effectiveness of a Transition Program for Adolescents With Congenital Heart Disease in the Transition to Adulthood
NCT ID: NCT02675361
Last Updated: 2021-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
189 participants
INTERVENTIONAL
2016-07-01
2021-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group: transition program
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.
Transition program
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.
Comparison group
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.
No interventions assigned to this group
Control group
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.
No interventions assigned to this group
Interventions
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Transition program
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.
Eligibility Criteria
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Inclusion Criteria
* Swedish-speaking
* Diagnosed with a congenital heart disease
* Age: 16 years
Exclusion Criteria
* Acquired heart diseases
* Heart transplantation
16 Years
16 Years
ALL
No
Sponsors
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Swedish Heart Lung Foundation
OTHER
Swedish Children Heart Association
UNKNOWN
The Swedish Research Council
OTHER_GOV
Sahlgrenska University Hospital
OTHER
Skane University Hospital
OTHER
Norrlands University Hospital
OTHER
Karolinska University Hospital
OTHER
Swedish Council for Working Life and Social Research
OTHER
Göteborg University
OTHER
Responsible Party
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Principal Investigators
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Philip Moons
Role: PRINCIPAL_INVESTIGATOR
University of Gothenburg and KU Leuven
Locations
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Children's Heart Center, Queen Silvia Children and Youth Hospital
Gothenburg, , Sweden
Children Outpatient Clinic, Linköping University Hospital
Linköping, , Sweden
Children's Heart Center, Skåne University Hospital
Lund, , Sweden
Child and Adolescent Clinic, Örebro University Hospital
Örebro, , Sweden
Children's Outpatient Cardiology Clinic, Astrid Lindgrens Children's Hospital
Stockholm, , Sweden
Children's Outpatient Cardiology Clinic, Norrland University Hospital
Umeå, , Sweden
Children's Outpatient Cardiology Clinic, Academic Children's Hospital
Uppsala, , Sweden
Countries
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References
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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.
Hilderson 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.
Knauth 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.
Moons 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.
McDonagh 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.
Small 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.
Sable 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.
Lalji 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.
Bratt 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.
Acuna 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.
Other Identifiers
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STEPSTONES-ConHD
Identifier Type: -
Identifier Source: org_study_id
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