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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03342976
Study type Interventional
Source University of Turin, Italy
Contact
Status Completed
Phase N/A
Start date May 3, 2018
Completion date December 31, 2020

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