Psychological Support in Adult Patients With Marfan Syndrome

Rare Diseases Clinical Trial

— MARFANPSY  

Official title:

Psychological Help in Patients With Marfan Syndrome: the Role of Quality of Life, Coping Mechanisms, Psychosocial Aspects and Self-esteem Levels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712577
• Other study ID #: MarfanPsy
• Status: Recruiting
• Start date: January 9, 2023
• Est. completion date: October 9, 2024

Study information

• Verified date: January 2024
• Source: IRCCS Policlinico S. Donato
• Contact: Alessandro Pini, MD
• Phone: +390252774705
• Email: alessandro.pini[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: October 9, 2024
• Est. primary completion date: October 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects affected by Marfan syndrome;

• Subjects currently in follow-up at Cardiovascular Genetic Centre, IRCCS Policlinico San Donato;

• Signed informed consent.

Exclusion Criteria:

• Subjects with cognitive deficits

Related Conditions & MeSH terms

• Marfan Syndrome
• Psychology, Social
• Rare Diseases
• Syndrome

Intervention

Other:
• Questionnaire
Rosenberg Self- Esteem scale
• Questionnaire
Short Form 36 scale
• Questionnaire
Coping orientation to the problems experienced - New Version in Italian
• Questionnaire
Outcome Questionnaire - version 42.5

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 Months
Primary	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	8 Months
Primary	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	8 Months
Primary	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	8 Months