Assessment of Frailty in Elderly People With Ischemic Heart Disease Being Considered for Revascularisation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Quality Of Life Questionnaire
研究概览
简要总结
Participants aged 80 years or over, who attend Castle Hill Hospital with either stable angina or an acute coronary syndrome will be invited to participate in the study. After induction into the study, these participants will be assessed for frailty and quality of life (QoL) using predetermined assessment tools. Quality of life (QoL) will be assessed using the standardised SF-12 questionnaire proforma. Frailty assessment will be based on the use of the Fried Frailty Phenotype criteria and the Edmonton Frailty Scale. Patients will be reassessed at 3,9 and 24 months for their clinical outcomes, repeat frailty assessment and quality of life.
详细描述
STUDY SETTINGS: Cardiology and cardiothoracic out-patients and in-patient wards of Castle Hill hospital
SAMPLE SIZE CALCULATION: FRAIL-HEART is a preliminary observational study designed to evaluate the practicality of undertaking frailty assessments in this population. The sample size of n=150 is estimated on the basis of feasibility. Investigators aim to recruit all consecutive patients who attend our department over a 1 year period. With an expected drop-out rate of 10% , investigators anticipate that it will be feasible to enrol 150 patients in the required time-frame.
PARTICIPANTS: The study target population will be patients aged 80 years or more, who are admitted or referred to the cardiology department because of underlying coronary artery disease.
IDENTIFICATION & RECRUITMENT: These participants will be recruited into the study from outpatient cardiology clinics and from identification of suitable inpatients admitted to the cardiology and cardiothoracic units.
BASELINE ASSESSMENT: The baseline assessment will include gathering patient baseline demographic data, current diagnosis and clinical status, assessment of the comorbid conditions, and information regarding relevant investigation results including blood results, electrocardiogram (ECG), echocardiogram and coronary angiography data. Participants will be asked to complete QoL questionnaire and undergo the frailty assessments. This will entail completion of several questionnaires.
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 80 years and above and either
- •Have been seen in the cardiology out-patient department with a diagnosis of stable angina
- •Have been admitted to Castle Hill Hospital with non-ST elevation acute myocardial infarction (NSTEMI)
- •Have been admitted to Castle Hill Hospital with ST-elevation acute myocardial infarction (STEMI)
- •Have been referred to Castle Hill Hospital for coronary angioplasty
- •Have been referred to Castle Hill Hospital for coronary artery bypass graft surgery
排除标准
- •Patients will be excluded from the study in the event of any of the following:
- •Patients who are unable to provide informed consent including those with advanced dementia.
- •Patients, who are not able to speak good English sufficiently to be able to understand the study information, give consent and complete study measures.
- •Patients who have a primary diagnosis of significant valvular disease
结局指标
主要结局
Change in Quality Of Life Questionnaire
时间窗: baseline and 3, 9 and 24 months
The primary out come will be quality of life assessed by SF-12 survey forms
次要结局
- Change in frailty Status - Fried frailty Criteria(baseline and 3, 9 and 24 months)
- Major adverse clinical events during hospitalization(baseline and 3, 9 and 24 months)
- Predictors of adverse outcome(baseline and 3, 9 and 24 months)
- Change in frailty Status - Edmonton Frailty Score(baseline and 3, 9 and 24 months)
- Major Adverse Clinical Event(24 months)