Congenital Heart DiseasesNCT03005626
Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases
A study testing Therapeutic education and Standard follow-up in people with Congenital Heart Diseases, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The Investigators aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Congenital Heart Diseases
- What is being tested?
- Therapeutic education and Standard follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 16 Nov 2020
- 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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient from 13 years to 25 years inclusive.
- Carrying of Congenital Heart Disease as defined in the International Classification.
- Possible follow-up for one year on one of the three hospital center.
- Informed consent of the patient for adults and, parents or legal guardians for minors.
- Affiliation to a social security system.
Who cannot join
- Non-francophone,
- Severe intellectual impairment.
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, 34295
About this study
Official title: Transition From Adolescents to Adulthood for Patients With Congenital Patients With Congenital Heart Diseases: Impact of a Therapeutic Education Program on Quality of Life
The Investigators aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.
Read the detailed description
The number of adults with congenital heart diseases (CHD) is increasing. However, many young adults are lost to follow-up even in experienced tertiary care centers. American and European guidelines recommend to improve the management of young adults with CHD. Structured therapeutic education programs are therefore needed to optimize the transfer to adult healthcare. Our tertiary care CHD center recently implemented a transition program and simultaneously investigators decided to measure its impact. Indeed investigators need data from randomized trials in this filed. After previous controlled quality of life studies among children and adults with CHD, investigators chose to use the health-related quality of life (HR-QoL) as primary endpoint in this randomized study to focus on patient related outcomes.
The investigators assume that patients who participate in this program will improve their quality of life compared to controls. If investigators demonstrate the benefit of this program, it will have important consequences for patients with CHD and eventually for patients with other chronic medical conditions.
- Conditions
- Congenital Heart Diseases
- Being tested
- Therapeutic education, Standard follow-up
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educationOther
Standard follow-upOther
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic education | Experimental | Structured therapeutic education programs Receives: Other: Therapeutic education |
| Control group | Active comparator | standard outpatient follow-up Receives: Other: Standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL 4.0 score
Evolution of the quality of life assessed by PedsQL 4.0 self-reported scores from month 0 to month 12.
Measured: Follow up of patients over 12 months
Secondary outcomes (5)
Physiological parameters
Evolution of the physiological parameters during a cardiopulmonary exercise test performed on a treadmill according to a modified Bruce protocole. Evolution of the physiological parameters from month 0 to month 12
Measured: Follow up of patients over 12 months
Ricci and Gagnon score
Evolution of the physical activity assessed by Ricci and Gagnon scores from month 0 to month 12. Ricci and Ganon score is a physical activity self-questionnaire with a total score out of 40 (<16 points: not very active, between 16 and 32 points: fairly active, > 32 points: very active).
Measured: Follow up of patients over 12 months
Leuven Knowledge score
Evolution of the knowledge of the disease assessed by Leuven Knowledge scores from month 0 to month 12. The level of knowledge was assessed by the "transition readdiness assessment" instrument : 10-item questionnaire reflecting the basic knowledge of the diseases and its management.
Measured: Follow up of patients over 12 months
Disease severity
The evolution of the severity of the disease from month 0 to month 12 was assessed by the degree of heart failure (NYHA functionnal class I to IV) and the number of hospitalizations (in stays and days) for complications related to the congenital heart disease
Measured: Follow up of patients over 12 months
Anxiety and depression
The evolution of the levels of depression and/or anxiety from month 0 to month 12 was assessed respectively by :
- the BDI (Beck Depression Inventory) for young adults
- the CDI (Child Depression Inventory) for adolescents
- the STAI (State and Trait Anxiety Inventory) for adults and STAI-C (Children) for adolescents.
A higher score is associated with a higher risk of depression/anxiety.
Measured: Follow up of patients over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005626
- Sponsor's protocol ID
- 9752
- Status last verified
- Jun 2026
- First submitted
- 26 Dec 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Werner O, Abassi H, Lavastre K, Guillaumont S, Picot MC, Serrand C, Dulac Y, Souletie N, Acar P, Bredy C, Amedro P. Factors influencing the participation of adolescents and young adults with a congenital heart disease in a transition education program: A prospective multicentre controlled study. Patient Educ Couns. 2019 Dec;102(12):2223-2230. doi: 10.1016/j.pec.2019.06.023. Epub 2019 Jun 26.
PubMed 31262673Bredy C, Werner O, Huguet H, Guillaumont S, Auer A, Requirand A, Lavastre K, Abassi H, De La Villeon G, Vincenti M, Gavotto A, Vincent R, Pommier V, Dulac Y, Souletie N, Acar P, Karsenty C, Guitarte A, Berge M, Marguin G, Masseron MP, Pages L, Bourrel G, Engberink AO, Million E, Huby AC, Leobon B, Picot MC, Amedro P. Efficacy of a Transition Program in Adolescents and Young Adults With Congenital Heart Disease: The TRANSITION-CHD Randomized Controlled Trial. J Adolesc Health. 2024 Aug;75(2):358-367. doi: 10.1016/j.jadohealth.2024.04.022. Epub 2024 Jun 10.
PubMed 38864791Werner O, Bredy C, Lavastre K, Guillaumont S, De La Villeon G, Vincenti M, Gerl C, Dulac Y, Souletie N, Acar P, Pages L, Picot MC, Bourrel G, Oude Engberink A, Million E, Abassi H, Amedro P. Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial. Health Qual Life Outcomes. 2021 Jan 19;19(1):23. doi: 10.1186/s12955-021-01668-1.
PubMed 33468144
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition From Adolescents to Adulthood for Patients With Congenital Patients With Congenital Heart Diseases: Impact of a Therapeutic Education Program on Quality of Life
- ClinicalTrials.gov ID
- NCT03005626
- Acronym / sponsor ID
- 9752
- Conditions
- Congenital Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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 aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.
Detailed description
The number of adults with congenital heart diseases (CHD) is increasing. However, many young adults are lost to follow-up even in experienced tertiary care centers. American and European guidelines recommend to improve the management of young adults with CHD. Structured therapeutic education programs are therefore needed to optimize the transfer to adult healthcare. Our tertiary care CHD center recently implemented a transition program and simultaneously investigators decided to measure its impact. Indeed investigators need data from randomized trials in this filed. After previous controlled quality of life studies among children and adults with CHD, investigators chose to use the health-related quality of life (HR-QoL) as primary endpoint in this randomized study to focus on patient related outcomes.
The investigators assume that patients who participate in this program will improve their quality of life compared to controls. If investigators demonstrate the benefit of this program, it will have important consequences for patients with CHD and eventually for patients with other chronic medical conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic education | Experimental | Other: Therapeutic educationStructured therapeutic education programs |
| Control group | Active comparator | Other: Standard follow-upstandard outpatient follow-up |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patient from 13 years to 25 years inclusive.
- Carrying of Congenital Heart Disease as defined in the International Classification.
- Possible follow-up for one year on one of the three hospital center.
- Informed consent of the patient for adults and, parents or legal guardians for minors.
- Affiliation to a social security system.
Key exclusion criteria (2 listed)
- Non-francophone,
- Severe intellectual impairment.
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 |
|---|---|---|
| Therapeutic education | Other | Therapeutic education |
| Standard follow-up | Other | Control group |
Primary outcome
PedsQL 4.0 score
Time frame: Follow up of patients over 12 months
Evolution of the quality of life assessed by PedsQL 4.0 self-reported scores from month 0 to month 12.
5 secondary outcomes
Physiological parameters
Time frame: Follow up of patients over 12 months
Ricci and Gagnon score
Time frame: Follow up of patients over 12 months
Leuven Knowledge score
Time frame: Follow up of patients over 12 months
Disease severity
Time frame: Follow up of patients over 12 months
Anxiety and depression
Time frame: Follow up of patients over 12 months
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 12 Jun 2026.
- Results publication: PubMed 31262673Werner O, Abassi H, Lavastre K, Guillaumont S, Picot MC, Serrand C, Dulac Y, Souletie N, Acar P, Bredy C, Amedro P. Factors influencing the participation of adolescents and young adults with a congenital heart disease in a transition education program: A prospective multicentre controlled study. Patient Educ Couns. 2019 Dec;102(12):2223-2230. doi: 10.1016/j.pec.2019.06.023. Epub 2019 Jun 26.
- Results publication: PubMed 38864791Bredy C, Werner O, Huguet H, Guillaumont S, Auer A, Requirand A, Lavastre K, Abassi H, De La Villeon G, Vincenti M, Gavotto A, Vincent R, Pommier V, Dulac Y, Souletie N, Acar P, Karsenty C, Guitarte A, Berge M, Marguin G, Masseron MP, Pages L, Bourrel G, Engberink AO, Million E, Huby AC, Leobon B, Picot MC, Amedro P. Efficacy of a Transition Program in Adolescents and Young Adults With Congenital Heart Disease: The TRANSITION-CHD Randomized Controlled Trial. J Adolesc Health. 2024 Aug;75(2):358-367. doi: 10.1016/j.jadohealth.2024.04.022. Epub 2024 Jun 10.
- Derived from this study: PubMed 33468144Werner O, Bredy C, Lavastre K, Guillaumont S, De La Villeon G, Vincenti M, Gerl C, Dulac Y, Souletie N, Acar P, Pages L, Picot MC, Bourrel G, Oude Engberink A, Million E, Abassi H, Amedro P. Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial. Health Qual Life Outcomes. 2021 Jan 19;19(1):23. doi: 10.1186/s12955-021-01668-1.
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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 Therapeutic education and Standard follow-up in people with Congenital Heart Diseases, run by University Hospital, Montpellier at 1 site in France.
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 2 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 12 Jun 2026. 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 France. 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?
PedsQL 4.0 score (time frame: Follow up of patients over 12 months). 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 NCT03005626, which also lists 3 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 12 Jun 2026.