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

Sponsor

Cardiocentro Ticino (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05696873

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Cardiovascular Disease

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

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)
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 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 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
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 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

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 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
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
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
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
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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