Effectiveness of a Transition Program for Adolescents With Congenital Heart Disease in the Transition to Adulthood
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

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.
    

Intervention name(s): Transition program
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Transfer to adult care; Continuity of patient care; Transition program