跳至主要内容
临床试验/NCT02618291
NCT02618291已完成不适用

Efficacy of a an Active Geriatric Evaluation (AGE Tool) for Geriatric Syndromes to Prevent Functional Decline in Elderly Patients in Family Medicine: a Pragmatic Cluster Randomized Trial

University of Lausanne2 个研究点 分布在 1 个国家目标入组 429 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
429
试验地点
2
主要终点
Basic Activities of Daily Living (ADL)

研究概览

简要总结

This study aims to test the efficacy of a comprehensive assessment and management tool (AGE: Active Geriatric Evaluation) for geriatric syndromes to prevent functional decline in elderly patients followed in family medicine. Family practitioners will be randomised either to the intervention, consisting of a yearly screening for eight geriatric syndromes accompanied by a management plan in case of positive screening, or to usual care. Level of functioning and quality of life of patients in both arms will be assessed over two years.

详细描述

The ageing of the population is associated to a rapid increase of chronic conditions and more specifically geriatric syndromes for which the health care system is largely unprepared. Being in frontline of this huge arising burden, family practitioners (FP) will need adapted tools to identify and manage elderly patients with complex needs and prevent functional decline while improving quality of life. It is however well recognized that effective and efficient evidence-based interventions adapted to the primary care setting are lacking. The AGE program (Active Geriatric Evaluation) was launched in 2011 and aimed at developing a comprehensive assessment and management tool for FP's to better identify and manage geriatric syndromes. The AGE tool consists of a 20-minute clinical screening instrument (Brief Assessment Tool, BAT), which performances for identifying geriatric syndromes was already assessed in general practice along the AGE program, and a comprehensive approach that encompasses: complementary diagnostic evaluations and propositions of management & treatment for each syndrome. The efficacy and efficiency of the AGE tool for preventing functional decline was never assessed in real life settings of general practice.

The aim of the study is to determine whether a comprehensive tool combining a brief assessment tool (BAT) for the early diagnosis of geriatric syndromes with a structured diagnostic and management strategy impacts on the functional decline and quality of life of elderly patients.

Design: Two-arm open label cluster randomized trial in FP practices, randomization unit: FP

Participants and setting: FP's and their patients aged ≥ 75 years in the French part of Switzerland. In total: 40 FP's (2x20) and 400 patients (2 x 200)

Intervention: Active Geriatric Evaluation. Controls: Usual care provided by FP's. Duration of study: 3 years (2 years of follow-up). Expected outcomes:functional ability of patients in the intervention arm ,measured through the activities of daily living, will be conserved compared to patients in the usual care arm.

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

入选标准

  • Aged 75 years or more
  • Consider the enrolling physician as his/her reference FP
  • Able to understand French
  • Living at home (not in institutions)
  • Visited his/her FP at least twice during the past year
  • Giving signed informed consent (or, in the absence of discerning capacity, giving assent in the presence of a surrogate signing the consent form)

排除标准

  • Having had a geriatric or specialized memory consultation in the past 3 months (including assessment during rehabilitation)
  • Planning to leave the study area or to change of FP in the next 2 years

结局指标

主要结局

Basic Activities of Daily Living (ADL)

时间窗: 2 years

Proportion of patients losing at least 1 basic ADL (6 items developed to assess functional status)

Instrumental Activities of Daily Living (IADL)

时间窗: 2 years

Proportion of patients losing at least 1 instrumental IADL (8 items developed to assess functional status)

次要结局

  • Health related quality of life (WHOQOL-OLD) score(2 years)
  • Incidence of institutionalization(During 2 years)
  • Incidence of emergency visits(During 2 years)
  • Incidence of hospital admissions(During 2 years)
  • Incidence of outpatient visits(During 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas Senn

Head of research and de development centre

University of Lausanne

研究点 (2)

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