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Clinical Trials/NCT05696873
NCT05696873
Recruiting
Not Applicable

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

Cardiocentro Ticino1 site in 1 country80 target enrollmentFebruary 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Cardiovascular Disease
Sponsor
Cardiocentro Ticino
Enrollment
80
Locations
1
Primary Endpoint
coping strategies and the adherence to cardiovascular medications
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 9, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Cardiocentro Ticino
Responsible Party
Principal Investigator
Principal Investigator

Marco Valgimigli

Deputy Chief

Cardiocentro Ticino

Eligibility Criteria

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

Outcomes

Primary Outcomes

coping strategies and the adherence to cardiovascular medications

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • cognitive fusion and participation to the trials(at discharge of index hospitalization (up to 4 weeks))
  • psychological flexibility evaluated with CVD-AAQ test and cardiovascular events(at 2 years (±14 days) from index hospitalization)
  • 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 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))
  • psychological flexibility evaluated with CVD-AAQ test and participation to the trials(at discharge of index hospitalization (up to 4 weeks))
  • cognitive fusion and adherence to cardiovascular medications(at 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(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(at discharge of index hospitalization (up to 4 weeks))
  • cognitive fusion and recurrence of cardiovascular events(at 2 years (±14 days) from index hospitalization)
  • psychological flexibility evaluated with CVD-AAQ test and adherence to cardiovascular medications(at 2 years (±14 days) from index hospitalization)

Study Sites (1)

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