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临床试验/NCT03608709
NCT03608709已完成不适用

Development of a Multivariable Prognostic PREdiction Model for 1-year Risk of FALLing in Community-dwelling Older Adults in a Non-clinical Setting

Aalborg University Hospital5 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2018年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
241
试验地点
5
主要终点
Number of falls

研究概览

简要总结

Falls in community-dwelling older adults is a frequent problem with an incidence of 30 % in over-65s and 50 % in over-80s. Incidences are expected to increase significantly in the future due to population aging. For instance, as of 2017, the global population older than 65 years is estimated to be 962 million and will increase to 1.4 and 2.1 billion in 2030 and 2050 respectively. In Denmark, falls are the most common accidents among older adults with around 36,000 fall accidents seen annually by the Danish health services and approximately 680 deaths yearly. This high frequency of fall accidents may also support the fact that falls in Denmark are the fourth most common reason for years lived with disability, thereby giving rise to reduced quality of life. Also, falls are associated with elevated morbidity, mortality, poorer physical functioning and early admission to long-term care facilities. Thus, this frequent and escalating problem of fall accidents is of major concern.

Fall prevention is therefore highly relevant. It is recognised that fall-preventive strategies should take on a multifaceted approach due the multifactorial aetiology of falls. This is substantiated by more than 400 risk factors of falling that have now been identified. These spread across different domains including socio-demographics, medical conditions (e.g. atrial fibrillation), medication, physical performance (e.g. reduced lower extremity strength or reaction time), psychology (e.g. depression or fear of falling) and cognition (e.g. global cognitive impairment or reduced executive functioning).

In order to aid health care professionals in targeting fall-preventive interventions, individual assessments of fall risk are imperative. In Denmark, municipalities are obliged to perform preventive initiatives to preserve the physical, mental and social health along with the functional capacity and quality of life of their older adults. The aim of these initiatives is to enable the older adults to live an independent and meaningful life for as long as possible. Recently, The Danish Health Authority released an updated manual to support this work. This emphasised the need for development of a validated prediction model to be used in a municipally environment to identify older adults at risk of falling. This is due to the abovementioned consequences of falls. To the knowledge of the authors, this is in line with literature being sparse on prognostic prediction models on falls in community-dwelling older adults with data collected outside a clinical environment (i.e. hospitals, GPs and screening or assessment centres).

Objectives:

Primary:

To develop and internally validate a multifactorial prognostic prediction model on fall risk in community-dwelling older adults in a non-clinical setting. The intended use of the model is, for municipalities, to identify and refer citizens with high risk of falls to fall-preventive interventions.

Secondary:

  1. To estimate time-consumption for the final prediction model.
  2. To describe the prevalence of arrhythmias in community-dwelling older adults.

详细描述

Study design and sample size:

A prospective cohort study with 1-year follow-up will be performed in collaboration with the municipality of Hjørring, Denmark. A total sample size of 500 participants is expected. This was chosen due to economical and administrative reasons of the municipality contributing with personnel to include participants and collect data on predictors. Data for the development and internal validation of the model will originate from the same cohort.

Study setting, participants, data collectors, process of recruitment and data collection:

According to Danish legislation on health and social services, Danish municipalities are responsible for developing and initiating prophylactic and health-promoting initiatives for their senior citizens. This is done through different authorities in the municipality (e.g. preventive-home-visits, senior activity centres). Also, the municipality of Hjørring administers a local hall for citizens together with general- and patient associations. Therefore, data collection will be performed in participants' own homes through preventive-home-visits, at senior activity centres and at the local hall in the municipality of Hjørring, Denmark.

Predictors:

研究设计

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

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

  • Community-dwelling older adults
  • 75 years old or above

排除标准

  • Presence of acute illness defined by the presence of a participant-reported experience of illness arisen within 7 days prior to inclusion impairing their everyday functioning in such a way that they opt out of social activities outside their homes while this state is present.
  • Unable to understand Danish evaluated by the data collectors.
  • Diagnosed with dementia.
  • Unable to stand up for 60 seconds without support and visually fixate on an object at the same time. Support is defined by any assistive devices or help from another person.

结局指标

主要结局

Number of falls

时间窗: 1 year follow up

Falls will be monitored using monthly prepaid fall calendars and validated by a phone call if a fall is registered. Also, circumstances of the fall will be asked about in the phone call. Blinding: Assessors of the outcome will be naturally blinded towards the predictors due to test results not being available before end of follow-up. Also, assessors of the outcome will be blinded to the questionnaire results by not having access to these in REDCap

次要结局

  • Arrhythmias(After 1 year)
  • Time consumption for the final prediction model(After 6 months)

研究者

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

Gustav Valentin Blichfeldt Sørensen

Principal Investigator

Aalborg University Hospital

研究点 (5)

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