Effectiveness of a Transition Program for Adolescents With Congenital Heart Disease in the Transition to Adulthood

Congenital Heart Disease Clinical Trial

Official title:

Effectiveness of a Transition Program to Empower Adolescents With Congenital Heart Disease in the Transition to Adulthood: the STEPSTONES Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675361
• Other study ID #: STEPSTONES-ConHD
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2021
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 16 Years

Eligibility

Inclusion Criteria:

• Literate
• Swedish-speaking
• Diagnosed with a congenital heart disease
• Age: 16 years

Exclusion Criteria:

• Syndromes affecting cognitive abilities
• Acquired heart diseases
• Heart transplantation

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Sweden	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

Sponsors (9)

Lead Sponsor	Collaborator
Göteborg University	Karolinska University Hospital, Norrlands University Hospital, Sahlgrenska University Hospital, Sweden, Skane University Hospital, Swedish Children Heart Association, Swedish Council for Working Life and Social Research, Swedish Heart Lung Foundation, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Three measurements over a 2-year period.
Secondary	Transition readiness	Readiness for transition questionnaire (adolescent version)	Three measurements over a 2-year period.
Secondary	Knowledge	Knowledge scale for adults with congenital malformed hearts	Three measurements over a 2-year period.
Secondary	Health behavior	Health behavior scale-congenital heart disease	Three measurements over a 2-year period.
Secondary	Patient reported health I	Questionnaire (PedsQL 4.0) (generic and cardiac module)	Three measurements over a 2-year period.
Secondary	Quality of life	Linear analog scale	Three measurements over a 2-year period.
Secondary	Patient reported health II	Questionnaire (EQ-5D-3L)	Three measurements over a 2-year period.
Secondary	Healthcare utilization	Healthcare utilization questionnaire	Three measurements over a 2-year period.