Singapore Cohort of Patients with Advanced Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in activities of daily living among patients through the last year of life
研究概览
简要总结
Chronic Heart Failure (CHF) is one of the leading causes of death in Singapore. Although it is well established that CHF patients in Singapore are less likely to be referred to palliative care services than cancer patients, little data is available on end-of-life (EOL) experience of advanced CHF patients in Singapore, including the inter-relationships between patient decision-making, quality of life trajectories, and health and cost consequences.
详细描述
To address this gap and to identify areas for better delivery of end-of-life services to patients with advanced CHF, the investigators propose to enrol a cohort of 300 patients with advanced CHF (New York Heart Association class III and IV), survey the participants every 4 months for a period of two years or till they die, whichever is earlier. The goal of this cohort study is to better understand the relationship between patient preferences, health care access, utilization, costs, and quality of life, and to identify strategies to improve the EOL experience for these patients. It is also important to recognize the significant role of the family in medical decision making in Asia. Previous studies from Singapore reveal that patients want their families to be involved in the decision making process. The role of the family in decision making is consistent with the Chinese culture of interdependency, obligations and filial piety. Decisions regarding treatment are often made by family caregivers, sometimes with little or no input from patients. Given this reality, the investigators will also enroll caregivers of the patients to evaluate their role in decision making for treatment of patients.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in activities of daily living among patients through the last year of life
时间窗: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Investigators will assess limitations in activities of daily living of patients through OARS Multidimensional Functional Assessment Questionnaire
Change in overall quality of life among patients through the last year of life
时间窗: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Investigators will assess patient's quality of life through FACT-G Time frame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months)
Change in patient's perceived quality of care during the last year of life
时间窗: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Investigators will describe patients' assessment of their own care using a scale used by Ayanian et al (JCO, 2010) that consists of 13 questions.
Change in distress among patients through the last year of life
时间窗: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Investigators will assess patients' distress through the distress thermometer
Change in patients' cognitive status
时间窗: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Investigators will assess patients' cognitive status through Montreal Cognitive Assessment
Change in patient's compliance with treatment regimens and self-care behaviours
时间窗: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months,24 months)
Investigators will describe patients' compliance with their self-care behaviour using the Self Care of Heart Failure Index (SCHFI)
Total health care expenditure during the last year of life through analysis of medical bills
时间窗: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Investogators will calculate total health care expenditure during the last year of patient's life as the sum total of expenditures incurred at clinics etc
次要结局
- Change in patient's awareness of hospice palliative care services among heart failure patients(From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months ))
- Change in caregiver burden through the last year of life(From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months))
- Caregiver's perception of patient's end-of-life care assessed after patient's death(8 weeks bereavement)
- Change in caregiver's level of emotional distress through the last year of life(From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months))
研究者
Eric A. Finkelstein
Professor
Duke-NUS Graduate Medical School