Clinical trial NCT05696873: CoPing strategIes-psyChological flexibiliTy in Patients Hospitalized for Ischemic cardiovascUlaR disEase (PICTURE)
Official title: CoPing strategIes-psyChological flexibiliTy in Patients Hospitalized for Ischemic cardiovascUlaR disEase (PICTURE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Cardiovascular Disease
Keywords: 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
Lead sponsor: Cardiocentro Ticino
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with age ≥ 18 years old and admission to the hospital for ischemic cardiovascular disease.

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.


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

Primary outcomes:
measure: 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)
timeFrame: 2 years (±14 days) from index hospitalization
measure: 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)
timeFrame: 2 years (±14 days) from index hospitalization
measure: coping strategies and the patient's decision to participate to the clinical trials approved in the centres
timeFrame: at discharge of index hospitalization (up to 4 weeks)
measure: psychological flexibility and the patient's decision to participate to the clinical trials approved in the centres
timeFrame: at discharge of index hospitalization (up to 4 weeks)
measure: coping strategies and the adherence to cardiovascular medications
timeFrame: 2 years (±14 days) from index hospitalization
measure: psychological flexibility and the adherence to cardiovascular medications
timeFrame: 2 years (±14 days) from index hospitalization
Secondary outcomes:
measure: each coping strategy and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death
timeFrame: 2 years (±14 days) from index hospitalization
measure: each component of psychological flexibility model and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death
timeFrame: 2 years (±14 days) from index hospitalization
measure: 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
timeFrame: at discharge of index hospitalization (up to 4 weeks)
measure: each component of psychological flexibility and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial
timeFrame: at discharge of index hospitalization (up to 4 weeks)
measure: cognitive fusion and recurrence of cardiovascular events
timeFrame: at 2 years (±14 days) from index hospitalization
measure: cognitive fusion and participation to the trials
timeFrame: at discharge of index hospitalization (up to 4 weeks)
measure: cognitive fusion and adherence to cardiovascular medications
timeFrame: at 2 years (±14 days) from index hospitalization
measure: psychological flexibility evaluated with CVD-AAQ test and cardiovascular events
timeFrame: at 2 years (±14 days) from index hospitalization
measure: psychological flexibility evaluated with CVD-AAQ test and participation to the trials
timeFrame: at discharge of index hospitalization (up to 4 weeks)
measure: psychological flexibility evaluated with CVD-AAQ test and adherence to cardiovascular medications
timeFrame: at 2 years (±14 days) from index hospitalization
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Enrico Frigoli
Study officials:
affiliation: Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,
name: Marco Valgimigli, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: