CoPing strategIes-psyChological flexibiliTy in Patients Hospitalized for Ischemic cardiovascUlaR disEase (PICTURE)

Ischemic Cardiovascular Disease Clinical Trial

— PICTURE  

Official title:

CoPing strategIes-psyChological flexibiliTy in Patients Hospitalized for Ischemic cardiovascUlaR disEase (PICTURE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696873
• Other study ID #: 02_PICTURE
• Status: Recruiting
• Start date: February 9, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Cardiocentro Ticino
• Contact: Marco Valgimigli, M.D., Ph.D
• Phone: +410918115111
• Email: marco.valgimigli[@]eoc.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this trial is to investigate the coping strategies/physiological flexibility construct in patients hospitalized for ischemic cardiovascular disease and the possible association with recurrence of clinical events (any hospitalization and type thereof, myocardial infarction, stroke and death) during the follow up, the patient's decision to participate to clinical trials approved in the center and the adherence to cardiovascular medications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age = 18 years old
• Able to provide informed consent
• Able to speak and read in the local language spoken in hospital
• Admission to the hospital for ischemic cardiovascular disease

Exclusion Criteria:

• Cannot provide written informed consent
• Under judicial protection, tutorship or curatorship
• Unable to understand and follow study-related instructions or unable to comply with study protocol
• Cognitive impairment
• Severe psychiatric disorders according to DSM-5-TR criteria diagnosed in the last 6 months

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Ischemia
• Ischemic Cardiovascular Disease

Locations

Country	Name	City	State
Switzerland	Enrico Frigoli	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Cardiocentro Ticino

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coping strategies and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death during the follow up period (2 years±14 days from index hospitalization)	coping strategies (evaluated using Brief COPE test) and the recurrence of clinical events (any hospitalization and type thereof, myocardial infarction, stroke and death) during the follow up period (2 years±14 days from index hospitalization)	2 years (±14 days) from index hospitalization
Primary	psychological flexibility and the recurrence any hospitalization and type thereof, myocardial infarction, stroke and death during the follow up period (2 years±14 days from index hospitalization)	psychological flexibility construct (evaluated using MPFI test - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the recurrence of clinical events (any hospitalization and type thereof, myocardial infarction, stroke and death) during the follow up period (2 years±14 days from index hospitalization)	2 years (±14 days) from index hospitalization
Primary	coping strategies and the patient's decision to participate to the clinical trials approved in the centres	coping strategies (evaluated using Brief COPE test) and the patient's decision to participate to the clinical trials approved in the centres	at discharge of index hospitalization (up to 4 weeks)
Primary	psychological flexibility and the patient's decision to participate to the clinical trials approved in the centres	psychological flexibility construct (evaluated using MPFI test - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the patient's decision to participate to the clinical trials approved in the centres	at discharge of index hospitalization (up to 4 weeks)
Primary	coping strategies and the adherence to cardiovascular medications	coping strategies (evaluated using Brief COPE test) and the adherence to cardiovascular medications	2 years (±14 days) from index hospitalization
Primary	psychological flexibility and the adherence to cardiovascular medications	psychological flexibility construct (evaluated using MPFI test and - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the adherence to cardiovascular medications	2 years (±14 days) from index hospitalization
Secondary	each coping strategy and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death	each coping strategy (evaluated using Brief COPE test) and the recurrence of clinical events type (any hospitalization and type thereof, myocardial infarction, stroke and death)	2 years (±14 days) from index hospitalization
Secondary	each component of psychological flexibility model and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death	each component of psychological flexibility model (evaluated using MPFI test - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the recurrence of clinical events type (any hospitalization and type thereof, myocardial infarction, stroke and death)	2 years (±14 days) from index hospitalization
Secondary	each coping strategy (evaluated using Brief COPE test) and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial	each coping strategy (evaluated using Brief COPE test) and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial, since it requires copying with the patient decision to self-administer treatment unlike other studies in which treatment is physician-directed	at discharge of index hospitalization (up to 4 weeks)
Secondary	each component of psychological flexibility and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial	each component of psychological flexibility construct (evaluated using MPFI test and - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial, since it requires copying with the patient decision to self-administer treatment unlike other studies in which treatment is physician-directed	at discharge of index hospitalization (up to 4 weeks)
Secondary	cognitive fusion and recurrence of cardiovascular events	cognitive fusion (evaluated using CFQ test - Cognitive Fusion Questionnaire) and recurrence of cardiovascular events	at 2 years (±14 days) from index hospitalization
Secondary	cognitive fusion and participation to the trials	cognitive fusion (evaluated using CFQ test - Cognitive Fusion Questionnaire) and participation to the trials	at discharge of index hospitalization (up to 4 weeks)
Secondary	cognitive fusion and adherence to cardiovascular medications	cognitive fusion (evaluated using CFQ test - Cognitive Fusion Questionnaire) and adherence to cardiovascular medications	at 2 years (±14 days) from index hospitalization
Secondary	psychological flexibility evaluated with CVD-AAQ test and cardiovascular events	psychological flexibility evaluated with CVD-AAQ test (Cardiovascular Disease Acceptance and Action Questionnaire) and cardiovascular events	at 2 years (±14 days) from index hospitalization
Secondary	psychological flexibility evaluated with CVD-AAQ test and participation to the trials	psychological flexibility evaluated with CVD-AAQ test (Cardiovascular Disease Acceptance and Action Questionnaire) and participation to the trials	at discharge of index hospitalization (up to 4 weeks)
Secondary	psychological flexibility evaluated with CVD-AAQ test and adherence to cardiovascular medications	psychological flexibility evaluated with CVD-AAQ test (Cardiovascular Disease Acceptance and Action Questionnaire) and adherence to cardiovascular medications	at 2 years (±14 days) from index hospitalization