Deciphering the Salutogenic Effects of Close Relationships: Psycho-physiological Coregulation Processes and Their Outcomes in Couples Coping With Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- The Medication Adherence Report Scale
研究概览
简要总结
The established attachment theory elucidates how early human bonds bring about functional neurophysiological alterations influencing the lifelong capacity for self and co- regulation within relationships. Based on this framework, the study will investigate potential psycho-physiological co-regulation processes in couples coping with cardiovascular disease, which may explain the established link between relationship satisfaction and recovery outcomes. In the proposed prospective, longitudinal study, the investigators will follow 81 volunteer couples in which one member has experienced an Acute Coronary Syndrome and assess their levels of interactive behavioral synchrony and the accompanying physiological synchrony (the mutual coordination of spouses' autonomic nervous systems), and stress buffering (reduced reactivity to stress in the individual) as assessed by Heart Rate Variability, and Galvanic Skin Response. It is hypothesized that higher levels of physiological synchrony and stress buffering will be associated with enhanced behavioral synchrony in the lab as well as patient outcomes three months later, on three dimensions: emotional (anxiety and depression reduction); behavioral (smoking cessation, medication adherence, cardiac rehabilitation participation) and physical (weight reduction, increased fitness).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •First Acute Coronary Syndrome
- •In a committed relationship lasting over a year
- •Registration at the Cardiac Prevention and Rehabiliation Center (CPRC)
排除标准
- •A history of previous cardiac events
- •A diagnosis other than Acute Coronary Syndrome, co-morbid conditions (such as cancer),
- •Lack of Hebrew as a native language.
- •Exclusion criteria for partners will be severe co-morbid conditions with life expectancy of less than 6 months (such as advanced cancer) and lack of Hebrew as a native language.
结局指标
主要结局
The Medication Adherence Report Scale
时间窗: 3 months
Patients will be asked to report on their medication adherence, using the Medication Adherence Rating Scale. Responses are summed for a total score ranging between 5 and 25, with higher scores indicating a higher level of adherence.
Hospital Anxiety and Depression Scale
时间窗: 3 months
contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'.
Smoking cessation
时间窗: 3 months
Smoking cessation will be defined as the delta between the number of cigarettes smoked before the cardiac event and the number of cigarettes smoked 3 months after the start of rehabilitation.
The Warwich-Edinburgh Mental Well-being Scale
时间窗: 3 months
A scale of 14 positively worded items for assessing a population's mental wellbeing. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Cardiac rehabilitation participation
时间窗: 3 months
The number of times patients participated in supervised exercise in the Cardiac Rehabilitation Center. Information regarding Rehabilitation participation will be retrieved from patients' computerized entry files.
Fitness change
时间窗: 3 months
Will be defined as the change in delta between 3 months after the start of rehabilitation ergometry score and the start of rehabilitation ergometry score (in Metabolic Equivalent of Task Score- METs).
Weight change
时间窗: 3 months
Weight change is defined as the delta between patients' body-mass index (BMI) from the beginning of rehabilitation and 3 months in.
次要结局
未报告次要终点
研究者
Noa Vilchinsky
prof.
Bar-Ilan University, Israel