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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Behavioral: Transition program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group: transition program<br>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. | Behavioral: Transition program<br>* 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.<br>|
| No Intervention: Comparison group<br>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 Intervention: Control group<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transfer to adult care, Continuity of patient care, Transition program