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临床试验/NCT03342976
NCT03342976已完成不适用

Evaluation of an ICT-based Platform for Early Detection and Intervention to Prevent Frailty in Older Adults

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2018年5月3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
201
试验地点
2
主要终点
Conversion rate from a pre-frail status to a frail status (Fried criteria)

研究概览

简要总结

This is a multicenter, multicultural, randomized control trial. Participants will be recruited from 10 centers located in Italy, Germany, Austria, Spain, United Kingdom, Belgium, Sweden, Japan, South Korea and Australia. The main objective of the study is to examine the efficacy of a sensor-based platform (my-AHA platform) to assess frailty risks and to deliver tailored interventions in order to prevent in elderly subjects conversion from a pre-frail status to a frailty status.

详细描述

In the past decade, frailty has attracted great attention of the scientific community and public health organizations as precursor and contributor of age-related diseases. Frailty is a common clinical syndrome in older adults, affecting 7-12% of the older population, and the occurrence of frailty increases with age and may exceed 45% after age 85 years. Frailty develops when age-associated degenerative processes overwhelm reserve capacity and reparative processes that maintain function of the nervous system as well as other physiologic systems. Overall, frailty consists in the vulnerability of aged population to adverse events as the result of the subtle and progressive metabolic and physical changes. Frailty confers a significantly increased risk for poor health outcomes, incident disability, hospitalization, and mortality.

In recent years there has been an emergence of information and communication technology (ICT) -based solutions to support active ageing and tackle frailty, cognitive decline and social isolation of older adults. While these ICT-based solutions are of a certain value regarding diminishing single risks (e.g. fall risk, etc.), there is still a need for a more holistic approach which aims to address all of the individual risk factors together. Also it is necessary to provide tailored interventions based on the outcomes of the risk analysis. This assessment of risk for frailty and provision of individual tailored interventions is the main objective of My-AHA project.

My-AHA solution supports active and healthy ageing by enabling early detection and minimization of risks associated with ageing. In these terms the early risk detection considers three fundamental aspects of the life of older adults: physical activity (by considering vital signs data, gait, quality of sleep and in general, physical activity, and fall risk); cognitive activity (by monitor the cognitive level, e.ge.g. in cognitive games); and, psychosocial activities (e.g. by analyzing the emotions and the quality of speech of the users). On the other hand, My-AHA will develop and implement more efficient and effective ICT-based interventions tailored to the early identified risks. The suggested social activities, as well as cognitive and physical trainings and the diet proposed to the older adults via the new platform will help the users in changing their behaviour and in reacting to the consequences of ageing.

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
Single (Care Provider)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for pre-screening
  • Age: over 60 yrs
  • Able to stand and walk unassisted
  • Free of significant cognitive impairment (age-corrected Mini Mental State Examination Test ≥ 24)
  • Free of clinically significant mood disturbance (HADS-Anxiety <15; HADS-depression < 15)
  • Free of any acute or unstable medical conditions
  • Able to understand directions and participate in the protocol
  • Able to sign informed consent
  • Subjects will be enrolled in the study if they meet one or two of the Fried et al. (2001) criteria for Frailty (Pre-Frailty status).
  • Shrinking, evidenced by weight loss (unintentional) ≥ 4.5 kg unintentional in prior 12 months; or at follow-up assessment ≥ 5% of body weight in prior 12 months.
  • 2, Weakness. Grip strength in lowest 20% at baseline adjusted for gender and BMI.
  • Poor endurance and energy. Self-report of exhaustion as indicated by responses to 2 questions on Center for Epidemiologic Studies Depression (CES-D) scale.
  • Slowness .Time to walk 15ft (4.57m) ≤ slowest 20% adjusted for gender and standing height.
  • Low physical activity level. Lowest quintile (25%) by gender for weighted kcal expenditure per week at baseline.

排除标准

  • Participant excluded if meets 1 or more of below:
  • Mobility problems
  • cannot stand and ambulate unassisted
  • painful arthritis, spinal stenosis, amputation, or painful foot lesions that limits balance and mobility,
  • Concurrent chronic disease independently contributing to frailty
  • suffers from a significant neurodegenerative disorder, e.g.
  • Alzheimer's disease
  • Lewy body dementia
  • Frontotemporal Lobar Degeneration, Fronto-Temporal Dementia
  • Parkinson's disease
  • multiple sclerosis
  • progressive supranuclear palsy
  • amyotrophic lateral sclerosis
  • hydrocephalus
  • Huntington's disease
  • prion diseases
  • affected by severe peripheral nervous system and/or neuromuscular disorders, e.g.
  • chronic inflammatory demyelinating polyneuropathy
  • myasthenia gravis
  • multiple sclerosis
  • polymyositis
  • Concomitant injury or disease known
  • clinical evidence or history of stroke (within 2 yrs) to impact independently cognitive,
  • clinical evidence or history of transient ischemic attack (within 6 months) psychological or physical function
  • significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment (2 years)
  • epilepsy (a single prior seizure is considered acceptable)
  • if meet Diagnostic and Statistical Manual 5 (DSM-5) criteria for:
  • major depressive disorder (current)
  • schizophrenia or other psychotic disorders (lifetime)
  • bipolar disorder (within the past 5 years
  • substance (including alcohol) related disorders (within the past 2 years)
  • Presence of cognitive, sensory or
  • have language deficits that impair testing perceptual deficits that interfere with assessment tasks
  • have significant visual impairment
  • have a significant hearing loss
  • Presence of other conditions or diseases that will compromise ability to undertake interventions (especially physical)
  • have clinically significant cardiovascular disease, i.e:
  • hospitalization for acute coronary syndrome (acute myocardial infarction or unstable, angina)
  • symptoms consistent with angina pectoris, within the 12 months
  • signs or symptoms of clinical heart failure within the 12 months
  • evidence of uncontrolled atrial fibrillation
  • a cardiac pacemaker
  • preexisting or current signs or symptoms of respiratory failure, e.g.
  • chronic obstructive pulmonary disease
  • bronchial asthma
  • lung fibrosis
  • other respiratory disease
  • untreated hypertension
  • metastatic cancer or immunosuppressive therapy
  • concurrent acute or chronic clinically significant immunologic, hepatic (such as presence of encephalopathy or ascites), or endocrine disease (not adequately treated).
  • 另有 2 项未显示

结局指标

主要结局

Conversion rate from a pre-frail status to a frail status (Fried criteria)

时间窗: 18 months

Comparison of conversion rate in cases and controls between pre-frail status fo frail status

次要结局

未报告次要终点

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Innocenzo Rainero

Associate Professor of Neurology

University of Turin, Italy

研究点 (2)

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