跳至主要内容
临床试验/NCT04297904
NCT04297904暂停不适用

Associations Between Urinary Incontinence, Sedentary Behaviour and Other Health-related Outcomes in Nursing Homes in Catalonia: the OsoNaH Project

University of Vic - Central University of Catalonia15 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2020年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
458
试验地点
15
主要终点
Patterns of sedentary behaviour

研究概览

简要总结

The increase of the older adult population in the past years has generated an important impact on chronic conditions and geriatric syndromes like dementia, falls and urinary incontinence (UI). To better understand IU seems warranted because of its socioeconomic and health impact. Nursing home (NH) residents are the frailest segment of our population, with very low physical activity levels and highly sedentary. Several studies had shown that physical activity levels and time and patterns of sedentary behaviour (SB) are independent risk factors for many health issues. As far as the investigators know, there is no evidence supporting the relation between IU and SB, and no information about the incidence of IU in NH residents living in Catalonia (Spain).

This project consists of two stages: stage 1 will conduct a cross-sectional study using mixed methodology (qualitative and quantitative), and a 2-year longitudinal study (stage 2). Stage 1 has the main objective of verifying the prevalence of IU and its associated factors in NH residents in Barcelona (Spain), as well as analyse the association between IU (and their types) with SB time and patterns. In addition, the proportion of geriatric residents who receive control measures for their IU, and whether they receive SB-related interventions from health professionals of the institution will be also explored. Finally, the investigators aim to understand the experience of NH residents and the health professionals who care for them about the characteristics, burden and barriers of having IU. Stage 2 has the main objective to verify the incidence of the functional and continence decline, falls, hospitalizations and mortality, as well as their predictive factors in older care/nursing home residents in Barcelona (Spain). Specific objetives are to assess the evolution of each activity of daily living and the causes of hospitalization and death in geriatrics residents for a period of 2 years and to verify the incidence of recurrent falls (one or more falls), and analyse the consequences of falls (fractures, hospitalizations, among others) among the residents. Potential risk and protective factors for mortality due to COVID-19 and its impact on functioning and hospitalizations will also be analyzed. Finally, the stage 2 of the project aims at creating a specific instrument for the evaluation of frailty in institutionalized older people, based on the main predictive factors of functional decline.

详细描述

The low birth rate and an increased life expectancy are transforming the age pyramid of the European Union (EU); probably the most important change will be the marked transition towards an aged society, a characteristic that is already evident in several EU member states. In 2017, the 65+ older adult's population had an increase of 0.3% compared to the previous year, and an increase of 2.4% compared to the previous 10 years. People over 80 years old are increasing at a faster rate than any other age segment of the EU population. This increase is probably linked to a growing demand for long-term care, which represents a significant overload on public health resources. Care/nursing homes are the main providers of long-term care. One of four older adults will spend a period of their life in a care/nursing home, and the dependence for such care will persist until their dead. The older adults who live in a nursing home are the most fragile of our society with high levels of physical dependence and one third of them suffering from cognitive impairment. An acute hospitalization typically is associated with multiple diseases in older people, and disability is frequently followed by high rates of progressive physical decline and mortality in the years following discharge. It is well known that hospital admission can change normal aging due to adverse health outcomes after hospitalization, especially in terms of functional decline, mortality frailty and cognitive impairment.

Frailty is one of the most important concerns regarding our aging population. Evidence grows that the syndrome is linked to several important health outcomes, prevalent in all countries and is a leading contributor to functional decline and early mortality in older adults. The last consensus defined frailty as "a clinical state in which there is an increase in an individual's vulnerability for developing an increased dependency and/or mortality when exposed to a stressor".

The decline in functionality is one of the main issues that affects older people because it limits their autonomy and leads to dependency. In older people, functional capacity can be defined as the ability to carry out a set of activities necessary for an independent life, the ability to carry out basic activities of daily living (BADL), those related to self-care and survival (such as bathing and eating), and more complex actions called instrumental activities (such as shopping and transportation). Functionality decline lead to high financial costs and are close associated with frailty, mobility problems, and increased risk of falls, dependency, hospitalization, and death. The association between functional decay and urinary incontinence (UI) could be bidirectional, which can lead to a cycle where continence reduction results in functional decline, and functional decline leads to further decrease in urinary continence.

The prevalence of UI in Spain is approximately 10% in women between 25 and 64 years old and over 50% in those over 65 years old. In the domain of nursing homes, this proportion is around 50% and is frequently associated with cognitive impairment, physical inactivity and immobility syndrome, among other factors. In this context, we can find a type of UI described as "functional" that it's caused by the inability to move to the bathroom independently, due to a physical or cognitive problem (e.g. dementia). Most older adults mistakenly believe that incontinence is part of the normal aging process and / or is an irresolvable problem. However, UI is a geriatric syndrome that represents an indicator of frailty and quality of health care, as well as a risk factor for pressure ulcers, falls, fractures and even urinary sepsis or death.

Falls, though preventable, are common among older adults, and the resulting injuries can threaten their health, independence, and lives. In 2014, 30% of older adults (aged > 65 years) in the United States reported falling at least once, and the estimated 29 million falls that year resulted in 7 million injuries and approximately 27,000 deaths. The evidence and research in Spain, shows that 30% of people over 65, independent and autonomous will be affected by an annual fall. This percentage increases progressively as age increases, because age is one of the main factors of risk in falls, being older people the ones with highest risk of suffering injuries, increased dependence, disabilities, institutionalization in centers and death, considering itself as a factor of frailty. In people over 75 years old its risk of fall rises to 35%, and in people over 80 years old it reaches 50%. Several studies estimate that this prevalence increases up to 50% in the case of institutionalized older people. Falls are an important public health problem, being an underdiagnosed problem, because when there are no physical consequences, do not usually go to the health system.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patterns of sedentary behaviour

时间窗: January 2020 to July 2020 (cross-sectional)

Patterns of sedentary behaviour (SB) with monitors (PAL Technologies, Scotland).

Urinary Incontinence

时间窗: January 2020 to July 2020 (cross-sectional)

The presence of IU assessed by the Minimum Data Set (MDS) version 3.0

Functional decline

时间窗: January 2020 to March 2022 (longitudinal, follow-up)

Modified (Likert 5-point scale) Barthel Index, assessed every 6 months

Continence decline

时间窗: January 2020 to march 2022 (longitudinal, follow-up)

Minimum Data Set (MDS) version 3.0, assessed every 6 months

Incidence of falls

时间窗: January 2020 to March 2022 (longitudinal, follow-up)

Prospective register of falls (date, place and consequence/s)

Hospitalizations

时间窗: January 2020 to March 2022 (longitudinal, follow-up)

Prospective register of hospitalizations (date and cause)

Mortality

时间窗: January 2020 to March 2022 (longitudinal, follow-up)

Prospective register of deaths (date and cause)

次要结局

  • Intake of liquids and diuretic drinks(January 2020 to July 2020)
  • Faecal incontinence(January 2020 to July 2020)
  • Lower urinary tract symptoms(January 2020 to July 2020)
  • Basic activities of daily living(January 2020 to July 2020)
  • Health conditions(January 2020 to July 2020)
  • Mobility(January 2020 to July 2020)
  • Physical performance(January 2020 to July 2020)
  • Incontinence programs(January 2020 to July 2020)
  • Type of births(January 2020 to July 2020)
  • Nutritional status(January 2020 to July 2020)
  • Biochemical evaluation(January 2020 to July 2020)
  • Social network(January 2020 to July 2020)
  • Change in medication(June 2020 to March 2022 (longitudinal, follow-up))
  • Sociodemographic variables(January 2020 to July 2020)
  • Physical activity programs(January 2020 to July 2020)
  • Frailty(June 2020 to March 2022 (longitudinal, follow-up))
  • Handgrip strength(January 2020 to July 2020)
  • Medication intake(January 2020 to July 2020)
  • Toxic habits(January 2020 to July 2020)
  • Cognitive status(January 2020 to July 2020)
  • Body composition(January 2020 to July 2020)
  • Loneliness(January 2020 to July 2020)
  • Depressive symptoms(January 2020 to July 2020)
  • Anxiety(January 2020 to July 2020)
  • Number births(January 2020 to July 2020)
  • Number of falls(January 2020 to July 2020)
  • Suspected case of COVID-19(June 2020 to March 2022 (longitudinal, follow-up))
  • Quality of life (European Quality of Life-5 Dimensions)(January 2020 to July 2020)
  • COVID-19(June 2020 to March 2022 (longitudinal, follow-up))

研究者

发起方
University of Vic - Central University of Catalonia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Jerez Roig

Ph.D. Research Delegate of the Faculty of Health Sciences and Wellfare of University of Vic - Central University of Catalonia. Head of research group on Methodology, Methods, Models and Outcomes of Health and Social Science (M3O)

University of Vic - Central University of Catalonia

研究点 (15)

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