ASSESSMENT OF THE ADEQUACY IN CARE OF THE FRAGILE PATIENT IN A DIGESTIVE ENDOSCOPY UNIT FRIEND Study (FRailty In ENDoscopy) Estudi FRIEND (FRailty In ENDoscopy)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,474
- 试验地点
- 2
- 主要终点
- Prevalence of frailty
研究概览
简要总结
The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures.
A geriatric assessment should be performed on all patients likely to present frailty prior to a digestive endoscopy to assess the risk-benefit of the indication and to improve patient preparation by avoiding adverse effects of endoscopic examinations, increasing the safety and profitability of the tests There are no data in our medium on the prevalence of frailty in patients referred for endoscopy, nor on the incidence in these patients of adverse effects, inadequate preparations, or incomplete examinations, so a frailty study is needed to elaborate multidisciplinary protocols that improve circuits and care in these patients and prevent complications.
The questions we want to try to answer are:
- Prevalence and severity of fragility in digestive endoscopy.
- Specific problems related to fragility in digestive endoscopy, mainly the profitability of the examination and the incidence of adverse effects, in order to create protocols for improving care in this group of patients.
详细描述
This is a prospective observational study.
In all patients older than 70 years referred for an ambulatory endoscopy, the presence of frailty and its degree will be assessed through validated questionnaires commonly used in the preparation of the patient for digestive endoscopy. A nurse trained by the Geriatrics Service of our hospital carries out a telephone contact with the patient or the patient's caregiver to fill out the questionnaires.
The formation of subgroups of patients will be assessed for the statistical analysis in relation to the degree of frailty and the type of endoscopy (upper or lower digestive endoscopy)
A random sample of 1474 individuals is sufficient to estimate, with 95% confidence and an accuracy of +/- 2.5 percentage units, a prevalence of frailty in the study population that is expected to be around 40%. Given that at this stage it is a cross-sectional study, no follow-up losses are expected.
Since the main aim of the study is cross-sectional, it is necessary to estimate the prevalence of frailty and a 95% confidence interval calculated using an exact method (Clopper-Pearson method).
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
- 70 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It will include all patients over 70 years of age who are indicated to undergo an ambulatory upper or lower endoscopy.
排除标准
- •Age below 70 years
- •Non-ambulatory endoscopies
- •Assessment of test contraindications by the endoscopist
- •Non-acceptance to enter the study
研究组 & 干预措施
Outpatients over 70 years of age referred to the Digestive Endoscopy Unit
Collection of variables: demographic variables, comorbidity, frailty (specific questionnaires), digestive endoscopy (upper and/or lower), possible complications related to the endoscopic process and the profitability and impact of the endoscopy.
干预措施: Collection of variables (Other)
结局指标
主要结局
Prevalence of frailty
时间窗: At the moment of telephone contact with the patient
Valuated frailty questionnaires (CFS and FRAGIL-VIG). Frailty is defined as a CFS rating greater than 4 or a FRAGIL-VIG value greater than 0. The degree of frailty is determined by FRAGIL-VIG score. The frailty questionnaires are completed during nurse telephone contact with the patient, prior to the digestive endoscopy.
次要结局
- Profitability of the endoscopy indication.(At the moment of endoscopy.)
- Cost of the endoscopy indication(At the moment of endoscopy)
- Degree of frailty(At the moment of telephone contact with the patient)
- Incidence of relevant complications during the endoscopy process.(30 days after digestive endoscopy.)
- Clinical impact of the endoscopy indication(Up to 2 months after endoscopy)