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

NCT05696873 | Recruiting

• 1 other identifier: 02_PICTURE
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• 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 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)

• 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)

• cognitive fusion and recurrence of cardiovascular events

  at 2 years (±14 days) from index hospitalization

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiocentro Ticino: lead

Study Sites (1)

Enrico Frigoli

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Marco Valgimigli, M.D., Ph.D

  Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Valgimigli, M.D., Ph.D

CONTACT

+410918115111; marco.valgimigli@eoc.ch

enrico frigoli, M.D.

CONTACT

enricofrigoli@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 25, 2023
• Study Start: February 9, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CH (1)