Congenital Heart DiseaseTELEMACONCT05713591
Transition Care Model for Adolescents With Congenital Heart Disease
A study testing Transition care model in people with Congenital Heart Disease, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The primary aim of this study is to assess the effectiveness of a standardized transition care model (TC) on the perceived mental and physical health of adolescents with congenital heart disease (CHD). Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Transition care model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 964 participants
- Where
- 1 siteItaly
- Study dates
- 3 May 2021to 31 Dec 2024
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent patients (aged between 12 and 18 years)
- Diagnosis of CHD, according to 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease
- All patients who express the willingness to participate in the study through the signing of the informed consent form and signature of informed consent by patients' parents
- Moderate and Complex CHD, according to the classification described by Warnes
Who cannot join
- Chromosomal abnormalities such as Down's syndrome and Marfan's syndrome
- Patients with cognitive impairment (assessed using Six Item Screener, SIS): if SIS ≤4
- Not understanding the Italian language
- Patients in pregnancy
- Simple CHD, according to Warnes (2001) (25).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, MI, 20097
Serena Flocco, +39 0252774940, serena.flocco@grupposandonato.it
About this study
Official title: Transition Care Model for Adolescents With Congenital Heart Disease (CHD): a Multicenter Study to Assess Its Effectiveness on Patient-reported Outcomes (TELEMACO Study)
The primary aim of this study is to assess the effectiveness of a standardized transition care model (TC) on the perceived mental and physical health of adolescents with congenital heart disease (CHD). Furthermore, the secondary aims of this research are focused on providing a description of the impact of a standardized TC on overall healthcare needs, satisfaction, and engagement.
Therefore, a prospective, randomized, controlled, single-blind, and multi-center study will be conducted.
Read the detailed description
Congenital heart diseases (CHD) are some of the most prevalent and serious birth defects, representing a major global health problem. With a prevalence of 9.1 for 1000 live births, the CHD are the leading causes of birth defects associated with morbidity, mortality, and medical expenditures. Currently, 1.3 million children live with a CHD worldwide (3), and approximately 90% of them can survive into adulthood. In this scenario, the transition from childhood to adulthood is one of the most complex and delicate part of life for CHD patients. The multi-disciplinary standardized interventions to educate and support patients with CHD, described as "Transition Clinic" (TC), represent a key element in delivering care for patients during the transition from childhood to adulthood. However, most recent literature focuses on the CHD childhood clinical management or the CHD adulthood challenges (i.e., GUCH challenges). Thus, the attention to exploring the peculiarities of the transition period from childhood to adulthood in patients with CHD is underinvestigated by the lack of experimental studies [i.e. randomized controlled trial (RCT)] as the published evidence is related to the assessment of effects of the same model on outcomes without a control arm (pre-post test study design).
- Conditions
- Congenital Heart Disease
- Being tested
- Transition care model
- Keywords
- congenital heart disease, transition care, quality of life, engagement
- 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.
Transition care modelBehavioural
The transition care model (TC) consists in multidisciplinary standardized interventions to educate and support adolescents with congenital heart disease, representing a key element in the adequate delivery of care to these individuals during their transition from childhood to adulthood. This model encompasses three main pillars previously described.
| Study group | Role | What they receive |
|---|---|---|
| Transition care model | Experimental | Patients in the experimental arm will receive the TC intervention which encompasses three main pillars that guided a standardized and structured clinical pathway to ensure an optimal transition from childhood care to adult care. Briefly, the first pillar was designed to improve the understanding of the clinical condition through tailored education. Healthcare providers delivered specific information and education strategies. The second pillar aimed to support the development of functional coping strategies by discussing with a counselor and/or a psychologist. The TC encompassed for this pillar both structured face-to-face discussions and counseling moments. The third pillar hoped to improve the engagement of CHD adolescents and their families. Receives: Behavioral: Transition care model |
| Usual care | No intervention | Patients in the control arm will receive a usual care approach without the high focus on standardization given by the experimental arm (e.g. without flyers and booklets or standardized moments of face-to-face counseling). Data collection will be performed using a consistent approach with the one described in the experimental arm: every three months in a year (T0, T1, T2, T3, and T4). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical and mental quality of life
This outcome will be measured through a self-report tool such as a short-form survey. The short-form survey allows for assessing physical and mental health. The score will be computed for each domain and a higher score indicates a better perception of quality of life.
Measured: up to 12 months
Secondary outcomes (3)
Engagement
Patient engagement will be measured through the Patient Health Engagement scale. The score will be computed based on four main constructs: blackout, arousal, adhesion, and eudaimonic project. The final score has been computed through the median of the values of each item, ranging from 1 to 7, and a higher score indicates a better perception of engagement.
Measured: Every 3 months from baseline, up to 12 months
Healthcare needs
Adolescent healthcare needs will be measured through the Healthcare Needs Scale for Youth with congenital heart disease during the transition to adulthood. The score will be computed based on four main constructs: healthcare education, clinical support, emotional support, and continuum of care. The final score ranged from 0 to 100 and higher scores indicate higher needs.
Measured: Every 3 months from baseline, up to 12 months
Satisfaction of patients
Adolescent satisfaction will be measured through the visual analog scale. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Every 3 months from baseline, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start3 May 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The model of Transition Care (TC) is a complex educational intervention that encompasses three main steps (first step: understanding of their clinical condition; second step: education and support; third step: involvement and collaboration). Each step was developed to include, simplify and standardize the implementation of targeted and personalized interventions. After the eligibility criteria check, patients will be randomized in experimental or control arms. Patients in the experimental arm were involved in the model TC, while patients in the control group received the standard of care. Data collection for each group was performed at baseline and at three, six, nine, and twelve months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 964 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serena Francesca Flocco, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713591
- Sponsor's protocol ID
- 127/int/2019
- Acronym
- TELEMACO
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition Care Model for Adolescents With Congenital Heart Disease (CHD): a Multicenter Study to Assess Its Effectiveness on Patient-reported Outcomes (TELEMACO Study)
- ClinicalTrials.gov ID
- NCT05713591
- Acronym / sponsor ID
- TELEMACO / 127/int/2019
- Conditions
- Congenital Heart Disease
- Keywords
- congenital heart disease, transition care, quality of life, engagement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 964 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Feb 2023 (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 primary aim of this study is to assess the effectiveness of a standardized transition care model (TC) on the perceived mental and physical health of adolescents with congenital heart disease (CHD). Furthermore, the secondary aims of this research are focused on providing a description of the impact of a standardized TC on overall healthcare needs, satisfaction, and engagement.
Therefore, a prospective, randomized, controlled, single-blind, and multi-center study will be conducted.
Detailed description
Congenital heart diseases (CHD) are some of the most prevalent and serious birth defects, representing a major global health problem. With a prevalence of 9.1 for 1000 live births, the CHD are the leading causes of birth defects associated with morbidity, mortality, and medical expenditures. Currently, 1.3 million children live with a CHD worldwide (3), and approximately 90% of them can survive into adulthood. In this scenario, the transition from childhood to adulthood is one of the most complex and delicate part of life for CHD patients. The multi-disciplinary standardized interventions to educate and support patients with CHD, described as "Transition Clinic" (TC), represent a key element in delivering care for patients during the transition from childhood to adulthood. However, most recent literature focuses on the CHD childhood clinical management or the CHD adulthood challenges (i.e., GUCH challenges). Thus, the attention to exploring the peculiarities of the transition period from childhood to adulthood in patients with CHD is underinvestigated by the lack of experimental studies [i.e. randomized controlled trial (RCT)] as the published evidence is related to the assessment of effects of the same model on outcomes without a control arm (pre-post test study design).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The model of Transition Care (TC) is a complex educational intervention that encompasses three main steps (first step: understanding of their clinical condition; second step: education and support; third step: involvement and collaboration). Each step was developed to include, simplify and standardize the implementation of targeted and personalized interventions. After the eligibility criteria check, patients will be randomized in experimental or control arms. Patients in the experimental arm were involved in the model TC, while patients in the control group received the standard of care. Data collection for each group was performed at baseline and at three, six, nine, and twelve months.
| Arm | Type | Receives |
|---|---|---|
| Transition care model | Experimental | Behavioral: Transition care modelPatients in the experimental arm will receive the TC intervention which encompasses three main pillars that guided a standardized and structured clinical pathway to ensure an optimal transition from childhood care to adult care. Briefly, the first pillar was designed to improve the understanding of the clinical condition through tailored education. Healthcare providers delivered specific information and education strategies. The second pillar aimed to support the development of functional coping strategies by discussing with a counselor and/or a psychologist. The TC encompassed for this pillar both structured face-to-face discussions and counseling moments. The third pillar hoped to improve the engagement of CHD adolescents and their families. |
| Usual care | No intervention | –Patients in the control arm will receive a usual care approach without the high focus on standardization given by the experimental arm (e.g. without flyers and booklets or standardized moments of face-to-face counseling). Data collection will be performed using a consistent approach with the one described in the experimental arm: every three months in a year (T0, T1, T2, T3, and T4). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent patients (aged between 12 and 18 years)
- Diagnosis of CHD, according to 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease
- All patients who express the willingness to participate in the study through the signing of the informed consent form and signature of informed consent by patients' parents
- Moderate and Complex CHD, according to the classification described by Warnes
Key exclusion criteria (5 listed)
- Chromosomal abnormalities such as Down's syndrome and Marfan's syndrome
- Patients with cognitive impairment (assessed using Six Item Screener, SIS): if SIS ≤4
- Not understanding the Italian language
- Patients in pregnancy
- Simple CHD, according to Warnes (2001) (25).
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 care modelThe transition care model (TC) consists in multidisciplinary standardized interventions to educate and support adolescents with congenital heart disease, representing a key element in the adequate delivery of care to these individuals during their transition from childhood to adulthood. This model encompasses three main pillars previously described. | Behavioural | Transition care model |
Primary outcome
Physical and mental quality of life
Time frame: up to 12 months
This outcome will be measured through a self-report tool such as a short-form survey. The short-form survey allows for assessing physical and mental health. The score will be computed for each domain and a higher score indicates a better perception of quality of life.
3 secondary outcomes
Engagement
Time frame: Every 3 months from baseline, up to 12 months
Healthcare needs
Time frame: Every 3 months from baseline, up to 12 months
Satisfaction of patients
Time frame: Every 3 months from baseline, up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
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 care model in people with Congenital Heart Disease, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Feb 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serena Flocco (+39 0252774940, serena.flocco@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical and mental quality of life (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2023.