Congenital Heart Disease in AdolescenceNCT05479630

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

A study testing Transition With a Heart (TWAH) in people with Congenital Heart Disease in Adolescence and Transitional Care, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 25 years
Conditions the study is for: Congenital Heart Disease in Adolescence, Transitional Care
What is being tested?: Transition With a Heart (TWAH)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteBelgium
Study dates: 5 Nov 2015to 1 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Ghent University Hospital
Ghent, 9000

Other trials in Belgium

About this study

Official title: 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.

Conditions: Congenital Heart Disease in Adolescence, Transitional Care
Being tested: Transition With a Heart (TWAH)
Keywords: Transitional care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transition With a Heart (TWAH)Other
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).

Study groups in NCT05479630
Study group	Role	What they receive
Adolescents and their parent of the intervention group	Experimental	Adolescents and their parent who are participating in TWAH Receives: Other: Transition With a Heart (TWAH)
Adolescents and their parent of the control group	No intervention	Adolescents and their parent who are not participating in TWAH

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in disease-related knowledge of adolescents of the intervention group (paired test)
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.
Measured: 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
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.
Measured: Through study completion, an average of 1 year from the transfer consultation

Secondary outcomes (4)

Change in health-related quality of life of adolescents of the intervention group (paired test)
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.
Measured: 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
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.
Measured: 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
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)
Measured: 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
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)
Measured: Through study completion, an average of 1 year from the transfer consultation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 20151 Dec 2022

First posted29 Jul 2022
Study start5 Nov 2015
Primary completion1 Dec 2021
Study completion1 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Congenital Heart Disease in AdolescenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Single group
Model description: A prospective quasi-experimental study will be conducted using a pre (intervention group only) - post-test design. In the pre-test only adolescents in the intervention group will be examined as baseline. During the post-test adolescents and parents of both the intervention group and control group will be examined in order to investigate differences between them and to better determine the influence of the intervention on the outcomes.
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05479630
Sponsor's protocol ID: 2015-1037
Status last verified: Jan 2023
First submitted: 16 Oct 2020
Last updated: 30 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

de Hosson M, De Backer J, De Wolf D, De Groote K, Demulier L, Mels S, Vandekerckhove K, Goossens E. Development of a transition program for adolescents with congenital heart disease. Eur J Pediatr. 2020 Feb;179(2):339-348. doi: 10.1007/s00431-019-03515-4. Epub 2019 Nov 22.
PubMed 31758312
Moons P, De Volder E, Budts W, De Geest S, Elen J, Waeytens K, Gewillig M. What do adult patients with congenital heart disease know about their disease, treatment, and prevention of complications? A call for structured patient education. Heart. 2001 Jul;86(1):74-80. doi: 10.1136/heart.86.1.74.
PubMed 11410567
van Staa A, Sattoe JN. Young adults' experiences and satisfaction with the transfer of care. J Adolesc Health. 2014 Dec;55(6):796-803. doi: 10.1016/j.jadohealth.2014.06.008. Epub 2014 Aug 19.
PubMed 25149686
Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001 Apr;37(5):1170-5. doi: 10.1016/s0735-1097(01)01272-4. No abstract available.
PubMed 11300418

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Congenital Heart Disease in Adolescence trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05479630
Acronym / sponsor ID: 2015-1037
Conditions: Congenital Heart Disease in Adolescence, Transitional Care
Keywords: Transitional care
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Collaborators: Universiteit Antwerpen
Study start: 5 Nov 2015 (actual)
Primary completion: 1 Dec 2021 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 29 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators consider the following hypothetical scenario:

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

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: A prospective quasi-experimental study will be conducted using a pre (intervention group only) - post-test design. In the pre-test only adolescents in the intervention group will be examined as baseline. During the post-test adolescents and parents of both the intervention group and control group will be examined in order to investigate differences between them and to better determine the influence of the intervention on the outcomes.

Arm	Type	Receives
Adolescents and their parent of the intervention group	Experimental	Other: Transition With a Heart (TWAH)Adolescents and their parent who are participating in TWAH
Adolescents and their parent of the control group	No intervention	–Adolescents and their parent who are not participating in TWAH

Who may qualify

Ages: 12 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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).	Other	Adolescents and their parent of the intervention group

Primary outcome

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.
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.

4 secondary outcomes

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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
Background: PubMed 31758312de Hosson M, De Backer J, De Wolf D, De Groote K, Demulier L, Mels S, Vandekerckhove K, Goossens E. Development of a transition program for adolescents with congenital heart disease. Eur J Pediatr. 2020 Feb;179(2):339-348. doi: 10.1007/s00431-019-03515-4. Epub 2019 Nov 22.
Background: PubMed 11410567Moons P, De Volder E, Budts W, De Geest S, Elen J, Waeytens K, Gewillig M. What do adult patients with congenital heart disease know about their disease, treatment, and prevention of complications? A call for structured patient education. Heart. 2001 Jul;86(1):74-80. doi: 10.1136/heart.86.1.74.
Background: PubMed 25149686van Staa A, Sattoe JN. Young adults' experiences and satisfaction with the transfer of care. J Adolesc Health. 2014 Dec;55(6):796-803. doi: 10.1016/j.jadohealth.2014.06.008. Epub 2014 Aug 19.
Background: PubMed 11300418Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001 Apr;37(5):1170-5. doi: 10.1016/s0735-1097(01)01272-4. No abstract available.
Reference no. 3Link provided by the sponsor.
Reference no. 4Link provided by the sponsor.
Individual participant dataSharing planned: No

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Optimizing Care Transitions in CHD
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Active, not recruiting
Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transition With a Heart (TWAH) in people with Congenital Heart Disease in Adolescence and Transitional Care, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05479630, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.