Frailty Assessment and Multimodal Treatment Strategies in the Elderly at Risk of Adverse Results and Functional Decline in the Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change from Baseline in Health Related Quality of Life (EuroQol 5D) at 3 and 18 months
研究概览
简要总结
This study aims to design a patient -centered program to prevent or delay frailty , functional decline and adverse events, and evaluates the effectiveness of the program with a randomized clinical trial.
详细描述
Objective
To design and evaluate the implementation and impact of a multimodal intervention focused on elderly patients living in the community in preventing or delaying frailty, functional decline and risk of institutionalization, hospitalization and death.
Design: Study in two phases: a qualitative study to develop the intervention and a randomized clinical trial with parallel arms and control group.
Intervention: Participants in the control group will receive the usual standard care and regular referrals. Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment (CGA). Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment, along with medication review, aerobics exercise plan and memory workshops following the model adapted in Phase I.
After 3 and 18 months, measures of functional and cognitive performance, quality of life, frailty, adverse outcomes (institutionalization, hospitalization, death) and health care costs will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive screen in the accumulation of deficits electronic frailty index
- •Positive screen with Gerontopole screening tool and/or RISC tool
排除标准
- •Living in an institution
- •Advanced conditions with short life expectancy
- •Severe disability
- •Severe Dementia
结局指标
主要结局
Change from Baseline in Health Related Quality of Life (EuroQol 5D) at 3 and 18 months
时间窗: 0, 3, 18 months
EuroQol 5D EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 18 months
时间窗: 0, 3, 18 months
The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
Change from Baseline in the Quick Mild Cognitive Impairment Screen (Qmci-S) at 3 and 18 months
时间窗: 0, 3, 18 months
The Quick Mild Cognitive Impairment (Qmci) screen is a multi-purpose, short cognitive screening instrument designed to differentiate between normal cognitive function, subjective cognitive disorders, mild cognitive impairment (MCI) and early dementia and to measure change over time.
次要结局
- Change from Baseline in the Gerontopole Frailty Screening Tool (GFST) at 3 and 18 months(0,3,18 months)
- Change from Baseline in Functional Capacity at 3 and 18 months(0, 3, 18 months)
- Change from Baseline in Clinical Frailty Scale (CFS) at 3 and 18 months(0,3 18 months)
- Change from Baseline in the Risk Instrument for Screening in the Community (RISC) at 3 and 18 months(0, 3, 18 months)