Rare DiseasesMARFANPSYNCT05712577
Psychological Support in Adult Patients With Marfan Syndrome
An observational study of Rare Diseases and Marfan Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The goal of this observational study is to identify key factors leading to psychotherapy or psychological support in adult subjects with Marfan syndrome (MSF). the main questions it aims to answer are: Understand and define which internal variables of the individual drive this request for psychological support; To… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rare Diseases, Marfan Syndrome, Psychology, Social
- What is being tested?
- Questionnaire
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2023to 9 Oct 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with MFS who have requested psychological support/psychotherapy and patients who have never requested psychological support/psychotherapy.
Who may be able to join
- Subjects affected by Marfan syndrome;
- Subjects currently in follow-up at Cardiovascular Genetic Centre, IRCCS Policlinico San Donato;
- Signed informed consent.
Who cannot join
- Subjects with cognitive deficits
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, 20097
Alessandro Pini, MD, +390252774705, alessandro.pini@grupposandonato.it
About this study
Official title: Psychological Help in Patients With Marfan Syndrome: the Role of Quality of Life, Coping Mechanisms, Psychosocial Aspects and Self-esteem Levels
The goal of this observational study is to identify key factors leading to psychotherapy or psychological support in adult subjects with Marfan syndrome (MSF). the main questions it aims to answer are:
- Understand and define which internal variables of the individual drive this request for psychological support;
- To learn about verify the impact that the clinical manifestations of MSF have on psychosocial aspects, self-esteem, subjective perception of the disease and coping mechanisms.
Read the detailed description
Patients following psychological interview during follow-up visits will be enrolled in the study.
The following self-report questionnaires will be used in understanding the impact the syndrome has on mental health and quality of life:
- Rosenberg Self- Esteem: 10 item Likert scale for assessing self-esteem;
- SF 36: 36 item scale assessing eight domains: physical functioning physical role limitations; bodily pain; general health perceptions; energy/vitality; social functioning; emotional role limitations and mental health;
- Cope NVI: to test measures coping behaviors as potential responses to stressors like social support, avoidance strategies, positive attitude, problem orientation and transcendent orientation;
- OQ45.2: measure of general psychological distress.
- Conditions
- Rare Diseases, Marfan Syndrome, Psychology, Social
- Being tested
- Questionnaire
- Keywords
- Marfan syndrome, Psychological support, Self-report
- Medical subject headings
- Rare Diseases, Marfan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Rosenberg Self- Esteem scale
QuestionnaireOther
Short Form 36 scale
QuestionnaireOther
Coping orientation to the problems experienced - New Version in Italian
QuestionnaireOther
Outcome Questionnaire - version 42.5
| Study group | Role | What they receive |
|---|---|---|
| MFS_PT+ | MFS patients who followed psychological support/psychotherapy Receives: Other: Questionnaire | |
| MFS_PT- | MFS patients who never followed psychological support/psychotherapy Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire performance
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables.
Questionnaire scoring:
- COPE NVI: scoring between 60 and 240; higher score means better outcome
Measured: 8 Months
Questionnaire performance
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables.
Questionnaire scoring:
- Short Form-36: scoring between 0 and 100; higher score means better outcome
Measured: 8 Months
Questionnaire performance
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables.
Questionnaire scoring:
- Rosenberg Self- Esteem scale: scoring between 0 and 30; higher score means better outcome
Measured: 8 Months
Questionnaire performance
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables.
Questionnaire scoring:
- Outcome questionnaire 42.5: socring between 0 and 180; clinical cut-off value is 64, higher score means worse outcome
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start9 Jan 2023
- Primary completion9 Oct 2024 (estimated)
- Study completion9 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Pini, IRCCS Policlinico S. Donato
- Investigators
- Alessandro Pini, MD, Principal investigator, Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712577
- Sponsor's protocol ID
- MarfanPsy
- Acronym
- MARFANPSY
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Help in Patients With Marfan Syndrome: the Role of Quality of Life, Coping Mechanisms, Psychosocial Aspects and Self-esteem Levels
- ClinicalTrials.gov ID
- NCT05712577
- Acronym / sponsor ID
- MARFANPSY / MarfanPsy
- Conditions
- Rare Diseases, Marfan Syndrome, Psychology, Social
- Keywords
- Marfan syndrome, Psychological support, Self-report
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 Oct 2024 (estimated)
- Study completion
- 9 Oct 2024 (estimated)
- First posted
- 3 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 goal of this observational study is to identify key factors leading to psychotherapy or psychological support in adult subjects with Marfan syndrome (MSF). the main questions it aims to answer are:
- Understand and define which internal variables of the individual drive this request for psychological support;
- To learn about verify the impact that the clinical manifestations of MSF have on psychosocial aspects, self-esteem, subjective perception of the disease and coping mechanisms.
Detailed description
Patients following psychological interview during follow-up visits will be enrolled in the study.
The following self-report questionnaires will be used in understanding the impact the syndrome has on mental health and quality of life:
- Rosenberg Self- Esteem: 10 item Likert scale for assessing self-esteem;
- SF 36: 36 item scale assessing eight domains: physical functioning physical role limitations; bodily pain; general health perceptions; energy/vitality; social functioning; emotional role limitations and mental health;
- Cope NVI: to test measures coping behaviors as potential responses to stressors like social support, avoidance strategies, positive attitude, problem orientation and transcendent orientation;
- OQ45.2: measure of general psychological distress.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MFS_PT+ | – | Other: QuestionnaireMFS patients who followed psychological support/psychotherapy |
| MFS_PT- | – | Other: QuestionnaireMFS patients who never followed psychological support/psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with MFS who have requested psychological support/psychotherapy and patients who have never requested psychological support/psychotherapy.
Key inclusion criteria (3 listed)
- Subjects affected by Marfan syndrome;
- Subjects currently in follow-up at Cardiovascular Genetic Centre, IRCCS Policlinico San Donato;
- Signed informed consent.
Key exclusion criteria (1 listed)
- Subjects with cognitive deficits
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 |
|---|---|---|
| QuestionnaireRosenberg Self- Esteem scale | Other | MFS_PT+, MFS_PT- |
| QuestionnaireShort Form 36 scale | Other | MFS_PT+, MFS_PT- |
| QuestionnaireCoping orientation to the problems experienced - New Version in Italian | Other | MFS_PT+, MFS_PT- |
| QuestionnaireOutcome Questionnaire - version 42.5 | Other | MFS_PT+, MFS_PT- |
Primary outcome
Questionnaire performance
Time frame: 8 Months
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables. Questionnaire scoring: - COPE NVI: scoring between 60 and 240; higher score means better outcome
Questionnaire performance
Time frame: 8 Months
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables. Questionnaire scoring: - Short Form-36: scoring between 0 and 100; higher score means better outcome
Questionnaire performance
Time frame: 8 Months
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables. Questionnaire scoring: - Rosenberg Self- Esteem scale: scoring between 0 and 30; higher score means better outcome
Questionnaire performance
Time frame: 8 Months
Statistical analysis between the two experimental groups using independent samples t-tests for continuous variables and associations for categorical variables. Questionnaire scoring: - Outcome questionnaire 42.5: socring between 0 and 180; clinical cut-off value is 64, higher score means worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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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.
Alessandro Pini, MD principal investigator
Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Diseases and Marfan Syndrome, 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 3 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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 Alessandro Pini, MD (+390252774705, alessandro.pini@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire performance (time frame: 8 Months). The study lists 4 primary outcomes in all. 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 12 Jan 2024.