Evaluation of Transition With a Heart, a Transition Program for Adolescents With Congenital Heart Disease and Parents

January 27, 2023 updated by: University Hospital, Ghent

A Prospective Quasi-Experimental Study to Evaluate Transition With a Heart, a Transition Project for Adolescents With Congenital Heart Disease and Their Parents With Focus on Disease Knowledge and Transitional Skills

The department of Congenital Heart Disease of the Ghent University Hospital (Belgium) developed a transition program dedicated to adolescents with congenital heart disease (CHD): 'Transition With a Heart´ (TWAH). TWAH was developed based on the Dutch program 'On your own feet´, starting at the age of 12 years and continuing after transfer. The most vital core components include a general and individualized flowchart, adolescent-centred communication, a joined transfer consultation and an appointed transition coordinator. TWAH focuses on promoting disease knowledge, autonomy and skills development of adolescents with CHD. Interventions encompass the use of a communication-paper, autonomously talking to professionals, individualized education and skills development plan. Interventions were selected from the highest sources of scientific evidence currently available including (quasi-) experimental studies, narrative literature reviews and expert opinions.

TWAH is the intervention in the conducted study. Hence, the intervention group are adolescents with CHD and their parents who are participating in TWAH. Adolescents and their parents who are transferred according to standard care (joined transfer consultation only) are identified as the control group and will be examined in the post test phase in order to be able to make comparisons with the intervention group. At baseline (the start of TWAH) participants of the control group already made the transfer to the adult ward.

The investigators consider the following hypothetical scenario:

- TWAH will have a positive influence on disease knowledge and transition experiences of the participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of a CHD of great or moderate complexity (6)
  • From the age of 12 years or older
  • Must be able to complete the questionnaires
  • Dutch speaking AND/OR
  • Parents having children who are meeting the inclusion criteria above

Exclusion Criteria:

-

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adolescents and their parent of the intervention group
Adolescents and their parent who are participating in TWAH
Other: Transition With a Heart (TWAH)
TWAH is a transition program, especially developed for adolescents with CHD and their parents. TWAH is starting at the age of 12 years and continuing after transfer. The most vital core components include a general and individualized flowchart, adolescent-centred communication, a joined transfer consultation and an appointed transition coordinator. TWAH focuses on promoting disease knowledge, autonomy and skills development of adolescents with CHD. Interventions encompass the use of a communication-paper, autonomously talking to professionals, individualized education and skills development plan. Details can be found in De Hosson et al, 2020 (1).
No Intervention: Adolescents and their parent of the control group
Adolescents and their parent who are not participating in TWAH

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in disease-related knowledge of adolescents of the intervention group (paired test)
Time Frame: At baseline (first transition outpatient visit around 14y) and through study completion, an average of 1 year from the transfer consultation
Total knowledge score assesed by the Leuven Knowledge Questionnaire for Congenital Heart Disease (LKQCHD): and consists of 27 multiple choice questions for girls and 25 items for boys (Philip Moons et al., 2001). The total knowledge score consists of a ratio of the sum of correct answers to the total number of questions resulting in a 0-100 scale, where a higher score reflects a better disease-related knowledge.
At baseline (first transition outpatient visit around 14y) and through study completion, an average of 1 year from the transfer consultation
Comparison between disease-related knowledge scores of adolescents of the intervention group and adolescents of the control group
Time Frame: Through study completion, an average of 1 year from the transfer consultation
Total knowledge score assesed by the Leuven Knowledge Questionnaire for Congenital Heart Disease (LKQCHD): and consists of 27 multiple choice questions for girls and 25 items for boys (Philip Moons et al., 2001). The total knowledge score consists of a ratio of the sum of correct answers to the total number of questions resulting in a 0-100 scale, where a higher score reflects a better disease-related knowledge.
Through study completion, an average of 1 year from the transfer consultation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in health-related quality of life of adolescents of the intervention group (paired test)
Time Frame: At baseline (first transition outpatient visit around 14y) and through study completion, an average of 1 year from the transfer consultation
Level of health-related quality of life of adolescents assesed by the Pediatric Quality of Life inventory (PEDSQoL) adolescent version: cardiac and general module. Adolescents were asked to indicate the degree to which they experienced problems with these respective items over the past month using a five-point Likert scale (from 0=never to 4=always). For calculating the total score, the answers were reversed and computed to the domain and total scores on a 0-100 scale, where a higher score reflects a higher perceived QoL.
At baseline (first transition outpatient visit around 14y) and through study completion, an average of 1 year from the transfer consultation
Comparison between levels of health-related quality of life of adolescents of the intervention group and adolescents of the control group
Time Frame: Through study completion, an average of 1 year from the transfer consultation
Level of health-related quality of life of adolescents assesed by the Pediatric Quality of Life inventory (PEDSQoL) adolescent version: cardiac and general module. Adolescents were asked to indicate the degree to which they experienced problems with these respective items over the past month using a five-point Likert scale (from 0=never to 4=always). For calculating the total score, the answers were reversed and computed to the domain and total scores on a 0-100 scale, where a higher score reflects a higher perceived QoL.
Through study completion, an average of 1 year from the transfer consultation
Comparison of transfer experiences between adolescents of the intervention group and the adolescents of the control group
Time Frame: Through study completion, an average of 1 year from the transfer consultation
Assesed with the On Your Own Feet Tranfer Experience Scale and consists of two subscales: 1) perceived alignment and collaboration between pediatric and adult care and 2) experienced preparation for transfer, including readiness. The items could be rated on a five-point Likert scale (from 1= strongly disagree to 5=strongly agree). The theoretical scores range from 11 to 55 for the first subscale and 7 to 35 for the second. A higher score reflects a higher level of satisfaction with the transitional process. In addition, the overall satisfaction of the transfer could be indicated using a using visual analogue scale (from 1 if completely unsatisfied to 10 if completely satisfied), as well as confidence in the pediatric cardiologist and the adult cardiologist (from 1= no confidence to 10=complete confidence)
Through study completion, an average of 1 year from the transfer consultation
Comparison of transfer experiences between parents in the intervention group and control group
Time Frame: Through study completion, an average of 1 year from the transfer consultation
Assesed with the On Your Own Feet Tranfer Experience Scale and consists of two subscales: 1) perceived alignment and collaboration between pediatric and adult care and 2) experienced preparation for transfer, including readiness. The items could be rated on a five-point Likert scale (from 1= strongly disagree to 5=strongly agree). The theoretical scores range from 11 to 55 for the first subscale and 7 to 35 for the second. A higher score reflects a higher level of satisfaction with the transitional process. In addition, the overall satisfaction of the transfer could be indicated using a using visual analogue scale (from 1 if completely unsatisfied to 10 if completely satisfied), as well as confidence in the pediatric cardiologist and the adult cardiologist (from 1= no confidence to 10=complete confidence)
Through study completion, an average of 1 year from the transfer consultation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universiteit Antwerpen

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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-1037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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