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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Cardiovascular Disease

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Marco Valgimigli, M.D., Ph.D; Phone Number: +410918115111; Email: marco.valgimigli@eoc.ch
• Study Contact Backup: Name: enrico frigoli, M.D.; Email: enricofrigoli@gmail.com

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • Enrico Frigoli
    • Contact: Enrico Frigoli, MD; Email: enrico.frigoli@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with age ≥ 18 years old and admission to the hospital for ischemic cardiovascular disease.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cardiocentro Ticino
• Investigators: Principal Investigator: Marco Valgimigli, M.D., Ph.D, Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: acceptance and commitment therapy; coping strategies; psychological flexibility; mental stress; ischemic cardiovascular disease; patient's decision to partecipate to clinical trial; adherence to the medications; hexaflex; Brief Cope test; MPFI test; CFQ test; MAAS-8 test; CVD-AAQ test
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Ischemia
• Other Study ID Numbers: 02_PICTURE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No