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

June 30, 2021 updated by: Göteborg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 416 85
        • Children's Heart Center, Queen Silvia Children and Youth Hospital
      • Linköping, Sweden, 581 85
        • Children Outpatient Clinic, Linköping University Hospital
      • Lund, Sweden, 221 85
        • Children's Heart Center, Skåne University Hospital
      • Stockholm, Sweden, 171 76
        • Children's Outpatient Cardiology Clinic, Astrid Lindgrens Children's Hospital
      • Umeå, Sweden, 901 85
        • Children's Outpatient Cardiology Clinic, Norrland University Hospital
      • Uppsala, Sweden, 751 85
        • Children's Outpatient Cardiology Clinic, Academic Children's Hospital
      • Örebro, Sweden, 701 85
        • Child and Adolescent Clinic, Örebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Three measurements over a 2-year period.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Karolinska University Hospital
The Swedish Research Council
Sahlgrenska University Hospital, Sweden
Swedish Council for Working Life and Social Research
Skane University Hospital
Swedish Heart Lung Foundation
Norrlands University Hospital
Swedish Children Heart Association

Investigators

  • Principal Investigator: Philip Moons, University of Gothenburg and KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEPSTONES-ConHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Coded files will be available only for research purposes. Information will be given after a letter with the intention of the study has been submitted to the Steering Committee who will determine whether to approve or deny the application.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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