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

Recruiting

• Conditions: Ischemic Cardiovascular Disease

• Registration Number: NCT05696873
• Lead Sponsor: Cardiocentro Ticino

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-25
• Study Start: 2023-02-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
coping strategies and the adherence to cardiovascular medications	2 years (±14 days) from index hospitalization	coping strategies (evaluated using Brief COPE test) and the adherence to cardiovascular medications
psychological flexibility 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 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
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)	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)
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)	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)
coping strategies 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 (evaluated using Brief COPE test) and the patient's decision to participate to the clinical trials approved in the centres
psychological flexibility and the adherence to cardiovascular medications	2 years (±14 days) from index hospitalization	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

Secondary Outcome Measures

Name	Time	Method
cognitive fusion and participation to the trials	at discharge of index hospitalization (up to 4 weeks)	cognitive fusion (evaluated using CFQ test - Cognitive Fusion Questionnaire) and participation to the trials
psychological flexibility evaluated with CVD-AAQ test and cardiovascular events	at 2 years (±14 days) from index hospitalization	psychological flexibility evaluated with CVD-AAQ test (Cardiovascular Disease Acceptance and Action Questionnaire) and cardiovascular events
each coping strategy and the recurrence of 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 recurrence of clinical events type (any hospitalization and type thereof, myocardial infarction, stroke and death)
each component of psychological flexibility and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial	at discharge of index hospitalization (up to 4 weeks)	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
psychological flexibility evaluated with CVD-AAQ test and participation to the trials	at discharge of index hospitalization (up to 4 weeks)	psychological flexibility evaluated with CVD-AAQ test (Cardiovascular Disease Acceptance and Action Questionnaire) and participation to the trials
cognitive fusion and adherence to cardiovascular medications	at 2 years (±14 days) from index hospitalization	cognitive fusion (evaluated using CFQ test - Cognitive Fusion Questionnaire) and adherence to cardiovascular medications
each component of psychological flexibility model and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death	2 years (±14 days) from index hospitalization	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)
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	at discharge of index hospitalization (up to 4 weeks)	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
cognitive fusion and recurrence of cardiovascular events	at 2 years (±14 days) from index hospitalization	cognitive fusion (evaluated using CFQ test - Cognitive Fusion Questionnaire) and recurrence of cardiovascular events
psychological flexibility evaluated with CVD-AAQ test and adherence to cardiovascular medications	at 2 years (±14 days) from index hospitalization	psychological flexibility evaluated with CVD-AAQ test (Cardiovascular Disease Acceptance and Action Questionnaire) and adherence to cardiovascular medications

Trial Locations

Locations (1)

Enrico Frigoli; 🇨🇭 Lugano, Switzerland