SIGBio Record Newsletter of the SIGBio ACM Special Interest Group

Dementia is one of the most relevant chronic diseases affecting the ageing population. The elder with mild or moderate cognitive impairment (MMCI) suffers of progressive cognitive decline with increasing difficulties in performing activities of daily living. Information and Communication Technology (ICT) for Healthcare can provide solutions to relief the caregivers’ burden and to support the elder in maintaining dignity and independence. The H2020 project aimed at developing and testing a bundle of hardware and software technologies able to fit the individual needs of the elder with MMCI and his/her formal and informal caregivers. The revolutionary design of UNCAP technologies and services required the development of a new paradigm for assessing their impact on the care system. Health Technology Assessment was the suitable instrument for multidimensional evaluation (safety, effectiveness, costs, impact). These tools was further refined and applied to UNCAP technologies by integrating HTA in all planning and development phase of the product, thus realizing the “HTA by design”. According to this new paradigm, all dimensions of analysis were taken into account starting from the conceptualization of UNCAP solution and requirement elicitation, to the prototype development and testing at pilot sites. Dementia in the EU aging population The world’s population is ageing rapidly with an estimation of 1 in 5 people over 65 years old by 2030 compared to 1 in 10 today. Due to chronic age-related illnesses, many progressively lose their autonomy and become more dependent on others, finally reaching the stage when they need round-the-clock care from their family members or caregivers. One of the most important chronic diseases that affect the ageing population is dementia. It accounts for 4.1% of total disease burden among people aged over 60 years and 40% of people older than 85. The number of people affected by this disease is increasing exponentially with an estimation of 35.6 million people with dementia in 2010, and numbers nearly doubling every 20 years [Prince, 2009]. According to the Global Deterioration Scale (GDS) [Reisberg, 1988], cognitive and functional abilities are categorized into 7 stages, ranging from no cognitive decline in the first stage to very severe cognitive decline in the seventh stage. Stage 5 denotes the point where it becomes difficult for the patient to live independently and assistance is needed from his/her family and/or caregivers. During stages 3 to 5 (mild and moderate cognitive impairments, MMCI), the elder suffers progressive cognitive decline and experience increasing difficulties in performing activities of daily living (ADLs). In some instances, MMCI elders may understand what they are supposed to be doing but they may not understand the instructions, or forget them midway through a task. They may also fail to recognize objects for what they are (agnosia) or to know how to execute learned tasks (apraxia). This means that the caregivers have to be present to help patients during their activities, and over time, increase the support they provide as the disease evolves [Aloulou, 2013]. Indeed, older adults, including people with MMCI, desire to remain in their homes as they age [CDC, 2013], creating significant challenges to manage the needs of increasing care while living at home. Since the 1980s, technology has been investigated as a possible support for the so called “aging in place” [Cook, 2009]. The technology advancesbring new opportunities to reduce both the burden of caregiving and the need for premature nursing home placement, due to family caregivers no longer being able to meet care demands. People with MMCI have a risk of hospitalizations and nursing home admissions triplicated compared to older adults with other conditions [Bossen 2015]. Family caregivers experience high levels of stress, burden, and role captivity that lead to negative physical, psychological, social, and spiritual outcomes [Zarit 2006; Brodaty, 2002; Schulz, 2008]. Caregivers of people with MMCI must cope with their loved one’s progressive memory loss, selfcare impairment, and communication breakdown. Caregiving stress, strain, and burden contribute to negative physical and mental health outcomes that include depression, insomnia, and psychotropic medication use, with notable increases in caregiver morbidity and mortality [Monin 2009]. Caregivers separated by distance face unique challenges as they manage caregiving from afar. They may worry about their family member’s safety and security, medication schedules, wandering, and need for information and socialization. The distant caregiver may be totally unaware of the needs of their family member, placing further burden on the onsite caregiver(s) [Bossen 2015]. UNCAP: personalized technology on individual needs Enhancing the well-being of people with MMCI and of their caregivers is a complex and evolving task. Information and Communication Technology (ICT) for Healthcare (e-Health) can effectively play an important role, provide solutions to relief the burden on caregivers, and support the individuals, with MMCI or other impairments, in maintaining dignity and independence while they age. UNCAP (“Ubiquitous iNteroperable Care for Ageing People”, GA 643555) is an European project that fosters a modern non-pharmacological approach as an appropriate initial strategy in the support and care of individuals with MMCI with the aim of improving users’ quality of life. The project involved 23 partners (including several pilot user partners) from 9 European countries (IT, UK, SI, RO, EL, DE, SE, ES, MK) with multidisciplinary backgrounds and competences. UNCAP has the aim to create and test a bundle of hardware and software technologies, customizable and flexible enough to adapt to the needs of the elder with MMCI and his/her formal and informal caregivers. In particular UNCAP technology provides:  Monitoring systems for: o Monitoring of physiological parameters o Monitoring of physical activity levels o Monitoring of activities of daily living o Falls detection  Ambient Assisted Living for: o Communications o Emergency call o Geofencing  Tracking and wayfinding for: o Falls prevention  Cognitive stimulation with: o Serious games  Cognitive aids as: o Reminder o Instructions. The complexity of toolsconsisting of both hardware and software components and incorporating customizable tools and services for assistive living (fall prevention, cognitive aids), monitoring (tracking and geo fencing), diagnostics (remote sensing, physiological parameters monitoring) and therapy (serious games, cognitive stimulation, exergames),as for UNCAP bundle, requires the development of new paradigms of performance and safety assessment,as well as its impact on the healthcare system. Since UNCAP technologies were conceived for treating, caringand alleviating a disease or impairment, UNCAP has been considered, from the beginning, as a Medical Device. According to this intents of use, the design, development and assessment were carry out in compliance with the European Directives and Regulations on Medical Devices (93/42/CEE andsubsequent amendments). In order to comply the forthcoming Regulation on Medical Device (2017/745 EU), data on effect should be provided in addition to safety for obtaining CE mark. Being UNCAP composed of innovative technologies, device safety and effect could not be extrapolated from literature and new clinical investigations should be realized. Moreover, a more comprehensive evaluation, covering also the economic and social impact for the introduction of a radically new technology is advised. Health Technology Assessment by design To fit this purpose, Health Technology Assessment (HTA) is a scientific methodology able to evaluate in a more comprehensive way several different dimensions including safety, effectiveness, costs, impacts and more. An European Project (EUnetHTA) delivered a reference framework for the HTA methodologies, called “HTA Core Model” [http://www.eunethta. eu/htacoremodel], aiming at the universalization of the elements of an HTA evaluation. However, ICT applications for health present specific characteristics, in terms of reliability, accuracy, etc. compared with other medical devices, making the traditional HTA approach, and also the “HTA Core Model”, unsuitable and not easily applicable. More recently, a new goal was reached in Telemedicine, a branch of e-Health, defining the “Model for Assessment of Telemedicine” (MAST) [http://www.mast-model.info/] delivered by the MethoTelemed European Project. MAST re-adjusted the “HTA Core Model”, identifying the following seven dimensions for the analysis of Telemedicine technologies:  Health’s problem and use of technology;  Safety;  Clinical effectiveness;  Patient’s perspective;  Economical aspects;  Organizational aspects;  Socio-cultural, ethical and legal aspects. MAST assessment methods wereapplied for UNCAP technologies, integrating the methodology into the planning and development phase of the product. So that, all MAST dimensions were considered since the conception of the device (not limiting just to safety and performance evaluation) thus moving towards the concept of “HTA by design”. Indeed, the MAST approach was used to write the proposal, to extract the system requirements, to realize the prototypes and to test UNCAP technology in pilot studies. The UNCAP multicentric trial Following this multi-dimensional evaluation approach, a multicenter clinical investigation was designed for assessing improvements in the quality of life of all users (primary and secondary users) and the impact on the use of resources for care. The objective of the investigation was also to assess safety and usability of UNCAP in responding to the needs of elderly people with mild and moderate cognitive impairment as well as evaluating primary and secondary users’ acceptance and satisfaction. Quantitative