Feasibility and Effectiveness of Frailty Screening and Management Programs Implemented in Different Clinical Settings (FRAILCLINIC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 821
- 试验地点
- 2
- 主要终点
- Functional Status assessed using the Barthel index for Basic Activities of Daily Living
研究概览
简要总结
Frailty is the main risk factor for the development of incident disability in older people and one of the most important for other adverse outcomes (death, hospitalisation, falls, and permanent institutionalisation).
Although frailty is a frequent condition in older adults who attend hospitals, little is known about its true prevalence in different settings of care. Better knowledge of this issue will inform the rational design of more effective strategies aimed at providing fitted care for these patients. Thus, the current study will potentially have impact on the quality of care for frail patients by revealing the prevalence of frailty in different settings of care, the difficulties in detection and management of frailty in these settings and the best instruments to detect frailty.
The investigators proposal brings together 6 partners in the European Union (EU) from three countries, with the common aim of studying the feasibility of a program to detect frail older patients in high risk clinical settings.
详细描述
Quality assurance plan:
- To perform regular monitoring according to the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP): The data will be evaluated according to the protocol and source documents.
- To give training to the centres involved in the study.
- To check the electronic Case Report Form (eCRF)
Data checks to compare data entered into the registry:
The eCRF has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none id card number will not be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.
Plan for missing data to address situations where variables are reported as missing:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frailty patients older than 75 years old attended in the settings of care.
- •Willing and able to provide informed consent
排除标准
- •Lack of capacity to give informed consent.
- •Those unable or unwilling to cooperate with any of the assessments
结局指标
主要结局
Functional Status assessed using the Barthel index for Basic Activities of Daily Living
时间窗: 36 months
will be assessed using the Barthel index for Basic Activities of Daily Living
Functional Status assessed using the Lawton index for Instrumental Activities of Daily Living
时间窗: 36 months
will be assessed using the Lawton index for Instrumental Activities of Daily Living
Mortality
时间窗: 36 months
number of deaths occurred either during hospitalization or at follow-up
Institutionalization (defined as the number of patients newly addressed to nursing)
时间窗: 36 months
defined as the number of patients newly addressed to nursing
次要结局
未报告次要终点