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临床试验/NCT04603144
NCT04603144尚未招募不适用

Identification of Frailty Predictors of Adverse Health Outcomes in Community-dwelling Individuals Aged 50 and Over: the SUCCEED Prospective Cohort

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
3,000
试验地点
1
主要终点
number of morbid events

研究概览

简要总结

Introduction. Although ageing is a general phenomenon, a great inter individual variability on the quality of ageing can be observed. This substantial heterogeneity may be partly explained by extrinsic factors such as lifestyle, habits, physical activity, diet, which may play an important role in the age-associated declines. The concept of frailty was introduced to account for variability in the aging process. This clinical and biological syndrome reflects a decrease in the physiological reserve, and leads to an insidious, precarious equilibrium that can break down during a stressful life event. In older adults, frailty is known to be associated with an increased risk of adverse outcomes, such as falls, fractures, unplanned hospitalizations, and death. Several frailty domains may only be slightly altered, so that early-stage frailty is not necessarily clinically visible. The most commonly used operational definitions of frailty are based on two different conceptual frameworks. Fried's rules-based criteria correspond to a physical phenotype, whereas the "Rockwood accumulative model" defines frailty as the accumulation of multiple deficits. These tools were built for individuals aged 65 and over. However, frailty can also be found in younger adults. Although the early detection of frailty is potentially important (since the condition might be reversible in its early stages), frailty has not been extensively investigated among middle-aged individuals. Indeed, most of the literature studies have focused on older adults or on a small number of frailty parameters the investigators hypothesized that the factors determining the main ageing-related adverse events are already present in middle age.

The main objectives of the SUCCEED cohort are therefore to 1/investigate the prevalence of frailty parameters in community-dwelling individuals aged 50 and over, 2/ assess the parameters' prognostic value for future adverse health events, 3/ investigate frailty classifications in this population and assess the evolution of profiles over time Method. The SUCCEED survey is a French retrospective and prospective cohort that includes community-dwelling individuals aged 50 years or over consecutively attending an outpatient clinic ("successful ageing") in a geriatric teaching hospital in the Paris area, France. Baseline parameters are collected using a self-administered questionnaire followed by an interview, physical measurements, and performance tests conducted by trained nurses, and then a standardized clinical evaluation by a geriatrician. This clinical assessment includes evaluation of autonomy, cognition, mood, balance, mobility, muscle strength, nutrition, comorbidities, continence, sensory functions, bone density, sleeping disorders.

Patients who have attended the outpatient clinic from the 01/01/2010 to 14/01/2020 are retrospectively included in the cohort, the other ones are prospectively included.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects aged 50 and over previously included in the SUCCEED survey as from 1/1/2010 and being followed up who do not refuse to allow their data to be used for research purposes
  • subjects aged 50 and over coming for the first time to the successful ageing clinic who do not refuse to allow their data to be used for research purposes

排除标准

  • Age below 50y
  • Individuals who refuse to allow their data to be used for research purposes
  • Legal guardianship
  • Subjects not able to understand the study questionnaires, based on investigator's judgement
  • Cognitive, mental or psychiatric condition that, based on investigator's judgement, would jeopardise study participation

结局指标

主要结局

number of morbid events

时间窗: from baseline,during 40 years of follow up maximum

occurrence of 1 morbid event defined by the following composite criteria: death or institutionalization or pathological fracture (Pouteau-Colles type wrist, vertebral fracture or compression, femoral neck) or unscheduled hospitalization or non-accidental fall.

次要结局

  • Overall Survival(from baseline , during 40 years of follow up maximum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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