Clinical trial NCT02675361: Effectiveness of a Transition Program for Adolescents With Congenital Heart Disease in the Transition to Adulthood
Official title: Effectiveness of a Transition Program to Empower Adolescents With Congenital Heart Disease in the Transition to Adulthood: the STEPSTONES Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Transfer to adult care
Continuity of patient care
Transition program
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Swedish Heart Lung Foundation
name: Swedish Children Heart Association
name: The Swedish Research Council
name: Sahlgrenska University Hospital
name: Skane University Hospital
name: Norrlands University Hospital
name: Karolinska University Hospital
name: Swedish Council for Working Life and Social Research
First posted: 2016-02-05
Enrollment: 189
Sex: ALL
Minimum age (years): 16
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of empowerment
timeFrame: Three measurements over a 2-year period.
Secondary outcomes:
measure: Transition readiness
timeFrame: Three measurements over a 2-year period.
measure: Knowledge
timeFrame: Three measurements over a 2-year period.
measure: Health behavior
timeFrame: Three measurements over a 2-year period.
measure: Patient reported health I
timeFrame: Three measurements over a 2-year period.
measure: Quality of life
timeFrame: Three measurements over a 2-year period.
measure: Patient reported health II
timeFrame: Three measurements over a 2-year period.
measure: Healthcare utilization
timeFrame: Three measurements over a 2-year period.
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Children's Heart Center, Queen Silvia Children and Youth Hospital
city: Linköping
country: Sweden
facility: Children Outpatient Clinic, Linköping University Hospital
city: Lund
country: Sweden
facility: Children's Heart Center, Skåne University Hospital
city: Stockholm
country: Sweden
facility: Children's Outpatient Cardiology Clinic, Astrid Lindgrens Children's Hospital
city: Umeå
country: Sweden
facility: Children's Outpatient Cardiology Clinic, Norrland University Hospital
city: Uppsala
country: Sweden
facility: Children's Outpatient Cardiology Clinic, Academic Children's Hospital
city: Örebro
country: Sweden
facility: Child and Adolescent Clinic, Örebro University Hospital
Study officials:
affiliation: University of Gothenburg and KU Leuven
name: Philip Moons
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1007/s11886-009-0042-8.
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.
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.
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.
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. No abstract available.
citation: 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.