CoPing strategIes-psyChological flexibiliTy in Patients Hospitalized for Ischemic cardiovascUlaR disEase (PICTURE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- coping strategies and the adherence to cardiovascular medications
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
coping strategies and the adherence to cardiovascular medications
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)
研究者
Marco Valgimigli
Deputy Chief
Cardiocentro Ticino