Effectiveness of a Transition Program for Adolescents With Congenital Heart Disease in the Transition to Adulthood
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 240 participants: 120 adolescents will be part of the randomized controlled trial (60 in the intervention arm; 60 in the comparison arm), and 120 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Effectiveness of a Transition Program to Empower Adolescents With Congenital Heart Disease in the Transition to Adulthood: the STEPSTONES Project|
- 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).
- Transition readiness [ Time Frame: Three measurements over a 2-year period. ]Readiness for transition questionnaire (adolescent version)
- Knowledge [ Time Frame: Three measurements over a 2-year period. ]Knowledge scale for adults with congenital malformed hearts
- Health behavior [ Time Frame: Three measurements over a 2-year period. ]Health behavior scale-congenital heart disease
- Patient reported health I [ Time Frame: Three measurements over a 2-year period. ]Questionnaire (PedsQL 4.0) (generic and cardiac module)
- Quality of life [ Time Frame: Three measurements over a 2-year period. ]Linear analog scale
- Patient reported health II [ Time Frame: Three measurements over a 2-year period. ]Questionnaire (EQ-5D-3L)
- Healthcare utilization [ Time Frame: Three measurements over a 2-year period. ]Healthcare utilization questionnaire
|Study Start Date:||July 2016|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: 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.
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.
No Intervention: 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 Intervention: Control group
Participants in this group will receive usual care. Follow-up visits will depend on the complexity of the disease.
Two clinics comprise this section of the study and will be part of an longitudinal, observational study, which investigators will use as a control group.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02675361
|Contact: Ewa-Lena Bratt, PhDfirstname.lastname@example.org|
|Contact: Carina Sparud-Lundin, PhDemail@example.com|
|Children's Heart Center, Queen Silvia Children and Youth Hospital||Recruiting|
|Gothenburg, Sweden, 416 85|
|Contact: Jan Sunnegårdh firstname.lastname@example.org|
|Children's Heart Center, Skåne University Hospital||Recruiting|
|Lund, Sweden, 221 85|
|Contact: Katarina Hanséus email@example.com|
|Children's Outpatient Cardiology Clinic, Astrid Lindgrens Children's Hospital||Recruiting|
|Stockholm, Sweden, 171 76|
|Contact: Per Winberg firstname.lastname@example.org|
|Children's Outpatient Cardiology Clinic, Norrland University Hospital||Recruiting|
|Umeå, Sweden, 901 85|
|Contact: Annika Rydberg Annika.email@example.com|
|Principal Investigator:||Philip Moons||University of Gothenburg and KU Leuven|