Ischemic Cardiovascular Disease
Conditions
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
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.
Interventions
None listed
Sponsors
Cardiocentro Ticino
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
Countries
Switzerland
Contacts
Primary ContactMarco Valgimigli, M.D., Ph.D
Backup Contactenrico frigoli, M.D.
Outcome results
None listed