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

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.

Conditions

• Congenital Heart Disease

Interventions

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.

Sponsors & Collaborators

• Swedish Heart Lung Foundation

  collaborator OTHER

• Swedish Children Heart Association

  collaborator UNKNOWN

• The Swedish Research Council

  collaborator OTHER_GOV

• Sahlgrenska University Hospital

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Norrlands University Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Swedish Council for Working Life and Social Research

  collaborator OTHER

• Göteborg University

  lead OTHER

Principal Investigators

• Philip Moons · University of Gothenburg and KU Leuven

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-01

Primary Completion

2021-06-30

Completion

2021-06-30

Countries

• Sweden

Study Locations