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临床试验/NCT03883425
NCT03883425已完成不适用

Frailty and Complexity Among Home Service Recipients: a Case-control Longitudinal Study

School of Health Sciences Geneva1 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
231
试验地点
1
主要终点
Complexity Index

研究概览

简要总结

The purpose of the study is to develop frailty and complexity computation algorithms based on the French version of the interRAI-HC and, in doing so, to provide homecare nurses with valid and reliable screening tools for their routine practice. By relying on a prospective observational case-control longitudinal study, the study intends to assess the predictive validity of the proposed indices with respect to undesirable health outcomes. Repeated measurement occasions, separated by 6-month intervals, will also allow for estimation of intra-individual change in frailty and complexity. In the study, elders living in the community and aged 65 or older are the target population, and three samples will be considered based on the a priori risks of adverse outcomes (case 1: formal home service recipients; case 2: formal home care recipients; control: free of formal home care or service). These groups will be compared on the observed rates of frailty and complexity and on their evolution over time. Results will allow for identification of subgroups of the aged population for whom early screening of frailty and complexity appears most relevant. Based on the findings, practice guideline will be proposed. They will entail the interpretation of the scores and recommendations for mounting adapted preventive strategies. Finally, the study will contribute to enhancing knowledge on the relation between frailty, a well-known concept in gerontology, and complexity, a concept increasingly referred to in the care literature but that still deserves operational and consensual definitions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • living in the community (private home)
  • resident of Canton Geneva, Switzerland
  • ability to hold a conversation in French (expression, comprehension)
  • oriented in time and space

排除标准

  • living in hospital / nursing home
  • not resident of Canton Geneva, Switzerland
  • not fluent in French
  • disoriented in time and space
  • person under tutorship

结局指标

主要结局

Complexity Index

时间窗: at baseline

Index with a value ranging from 0 to 100, computed as the sum of complexity items recorded with the interRAI-HC MDS divided by the number of items considered.

Frailty Index

时间窗: at baseline

Index with a value ranging from 0 to 100, computed as the sum of health deficits recorded with the interRAI-HC MDS divided by the number of deficits considered. Replication of Ludwig and Busnel, BMC, 2017 (REF2)

Change in frailty Index

时间窗: at 6 months and at 12 months

Change in the frailty index value; Expressed as a proportion, with the frailty index value at baseline as denominator and the observed frailty value as numerator.

Change in complexity Index

时间窗: at 6 months and at 12 months

Change in the complexity index value; Expressed as a proportion, with the complexity index value at baseline as denominator and the observed complexity value as numerator.

次要结局

  • Number of participants with falls(at 6 month, at 12 months)
  • Number of participants with physician visits(at 6 month, at 12 months)
  • Number of participants with emergency admissions(at 6 month, at 12 months)
  • Mortality rate(at 6 month, at 12 months)
  • Number of participants with hospitalizations(at 6 month, at 12 months)

研究者

发起方
School of Health Sciences Geneva
申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Ludwig

UAS associate professor

School of Health Sciences Geneva

研究点 (1)

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