Prevention and Treatment of Cardiovascular Disease: Protocol for the Assessment of Psychological, Neuropsychological Implications and Associated Disorders in Cardiology Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- effectiveness of psychoeducation
研究概览
简要总结
In view of the close interrelationship between the various organs and systems of the body, which cannot be examined in a parceled fashion but rather as an integrated system, this study aims to consider the potential risks associated with cardiovascular disease.
By identifying additional, often underestimated, altered functions that may affect the patient's quality of life and interfere with the performance of daily activities, this research study aims to evaluate the patient's functioning in an integrated manner to achieve a holistic view of the health and well-being of the patient and caregiver.
详细描述
The study design is observational and is planned to last approximately 24 months. The overall duration will be related to the time required for enrollment of all planned subjects, data analysis and publication of results.
The study aims to analyze and investigate the most common comorbidities in patients with cardiovascular disease. In addition, a specific focus will be devoted to the caregiver, who plays a key role for the cardiopathic patient.
In detail, the objectives of the project are:
- Evaluate the connection between cardiovascular disease and cognitive deficits;
- Evaluate the main psychopathologies related to cardiovascular diseases (anxiety, depression);
- Evaluate conditions and disorders associated with cardiovascular diseases (dysphagia, pneumophonic coordination disorders, respiratory sleep disorders);
- Evaluate the effectiveness of psychoeducational intervention;
- Evaluate the impact of cardiovascular disease on the caregiver.
A minimum of 218 patients recruited from those afferent at the U.O.S.D. Cardiology with NICU P.O. "Piemonte" in Messina will participate in the survey. Statistical power analysis was performed using G*Power software for a linear regression test, assuming a slope (H1) of 0.2 with a significance level (α) of 0.05 and a power (1 - β) of 0.85. The primary outcome variable considered for the calculation is the result of the SF-12 (or SF-36) test as a summary index of the effectiveness of psychoeducation. The calculation indicated a sample of 218 subjects as adequate for the purpose of detecting the hypothesized effect.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 85 years;
- •Confirmed diagnosis of cardiovascular disease;
- •Presence of chronic cardiovascular disease;
- •Absence of cognitive impairment or mild/moderate cognitive impairment (Mini Mental Score >26);
- •Patient who has given informed consent personally or through Legal Representative
排除标准
- •- Presence of severe psychiatric and neurological disorders
- •Presence of end-stage oncological disease.
- •Severe visual impairment that cannot be corrected by dioptric lenses
结局指标
主要结局
effectiveness of psychoeducation
时间窗: 24 months
The primary outcome variable considered for calculation is the result of the SF-12 (or SF-36) test as a summary index of the effectiveness of psychoeducation.
次要结局
未报告次要终点
研究者
Irene Cappadona
Psychologist
IRCCS Centro Neurolesi "Bonino-Pulejo"