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

This study is currently recruiting participants.
Verified May 2017 by Göteborg University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02675361
First Posted: February 5, 2016
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Swedish Heart Lung Foundation
Swedish Children Heart Association
The Swedish Research Council
Sahlgrenska University Hospital, Sweden
Skane University Hospital
Norrlands University Hospital
Karolinska University Hospital
Swedish Research Council for Health, Working Life and Welfare (FORTE)
Information provided by (Responsible Party):
Göteborg University
  Purpose

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.


Condition Intervention
Congenital Heart Disease Behavioral: Transition program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 189
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)
Arms Assigned Interventions
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.


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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675361


Contacts
Contact: Ewa-Lena Bratt, PhD +46766-184450 ewa-lena.bratt@gu.se
Contact: Carina Sparud-Lundin, PhD +4631-7866389 carina.s-lundin@fhs.gu.se

Locations
Sweden
Children's Heart Center, Queen Silvia Children and Youth Hospital Recruiting
Gothenburg, Sweden, 416 85
Contact: Jan Sunnegårdh       jan.sunnegardh@vgregion.se   
Children Outpatient Clinic, Linköping University Hospital Recruiting
Linköping, Sweden, 581 85
Contact: Eva Ferlund         
Contact       eva.fernlund@regionostergotland.se   
Children's Heart Center, Skåne University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Katarina Hanséus       katarina.hanseus@skane.se   
Children's Outpatient Cardiology Clinic, Astrid Lindgrens Children's Hospital Recruiting
Stockholm, Sweden, 171 76
Contact: Per Winberg       per.vinberg@karolinska.se   
Children's Outpatient Cardiology Clinic, Norrland University Hospital Recruiting
Umeå, Sweden, 901 85
Contact: Annika Rydberg       Annika.rydberg@pediatri.umu.se   
Children's Outpatient Cardiology Clinic, Academic Children's Hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Poppy Kazamia         
Contact       poppy.kazamia@gmail.com   
Child and Adolescent Clinic, Örebro University Hospital Recruiting
Örebro, Sweden, 701 85
Contact: Shalan Fadl         
Contact       shalan.fadl@regionorebrolan.se   
Sponsors and Collaborators
Göteborg University
Swedish Heart Lung Foundation
Swedish Children Heart Association
The Swedish Research Council
Sahlgrenska University Hospital, Sweden
Skane University Hospital
Norrlands University Hospital
Karolinska University Hospital
Swedish Research Council for Health, Working Life and Welfare (FORTE)
Investigators
Principal Investigator: Philip Moons University of Gothenburg and KU Leuven
  More Information

Publications:

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02675361     History of Changes
Other Study ID Numbers: STEPSTONES-ConHD
First Submitted: February 2, 2016
First Posted: February 5, 2016
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Göteborg University:
Transfer to adult care
Continuity of patient care
Transition program

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities