NCT05712577

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

January 25, 2023

Last Update Submit

January 11, 2024

Conditions

Rare DiseasesMarfan SyndromePsychology, Social

Keywords

Marfan syndromePsychological supportSelf-report

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

MFS_PT+

MFS patients who followed psychological support/psychotherapy

Other: Questionnaire

MFS_PT-

MFS patients who never followed psychological support/psychotherapy

Other: Questionnaire

Interventions

QuestionnaireOTHER

Rosenberg Self- Esteem scale

MFS_PT+MFS_PT-

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with MFS who have requested psychological support/psychotherapy and patients who have never requested psychological support/psychotherapy.

You may qualify if:

  • Subjects affected by Marfan syndrome;
  • Subjects currently in follow-up at Cardiovascular Genetic Centre, IRCCS Policlinico San Donato;
  • Signed informed consent.

You may not qualify if:

  • Subjects with cognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Lombardy, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Rare DiseasesMarfan Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alessandro Pini, MD

    Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Pini, MD

CONTACT

+390252774705alessandro.pini@grupposandonato.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 3, 2023

Study Start

January 9, 2023

Primary Completion

October 9, 2024

Study Completion

October 9, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

IT(1)