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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Cardiovascular Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic cardiovascular disease, mental stress, coping strategies, patient's decision to partecipate to clinical trial, adherence to the medications, psychological flexibility, acceptance and commitment therapy, hexaflex, Brief Cope test, MPFI test, CFQ test, MAAS-8 test, CVD-AAQ test