Periodic Reporting for period 3 - SMART4MD (Support, Monitoring and Reminder Technology for Mild Dementia) Reporting period: 2018-04-01 to 2019-11-30 Summary of the context and overall objectives of the project Population ageing within Europe has major social and economic consequences. Although many older people are able to support themselves and continue to make important contributions to society, the burden of non-communicable disease and disability increases with age, exerting pressures on health services and support systems. One of the most devastating conditions that predominantly affects older people is dementia . Dementia is not exclusively a condition of older people, but its prevalence increases sharply with age. The symptoms that comprise dementia can vary greatly, with people often experiencing memory loss but also problems in communication and attention as well as anxiety and depression. Treatment options currently remain centred on symptomatic treatment, the main class of drugs prescribed to people with mild to moderate AD dementia being cholinesterase inhibitors. There are currently about 10.5 million people in Europe with dementia, costing around €275 billion annually. Given that the number of people with dementia in Europe is expected to rise to 13.4 million by 2030, the challenge of dementia is likely to remain formidable . Healthcare policies are therefore focused on extending the ability of older people to continue to live independently, as a way of meeting these challenges. This entails maintaining their quality of life and working to reduce the costs of their care. SMART4MD project is an EU-scale research project focusing on experimental treatment of mild dementia. This project builds on an innovative patient support tool to develop an application that is specifically targeted to patients with mild dementia. The content and layout of SMART4MD application, which will be accessible via tablets given to patients in the study, will be based on findings from the first stage of the project focused on user-centric design (focus groups, interviews, tests), but will be based on simplicity, memory helpers, reminders, photos, information sharing with carers and doctors and easiness of use for the patients.The SMART4MD tool will help patients to adhere to their treatment, reduce the progression of their illness and share data with their carers and doctors. This will slow the patients’ cognitive and functional decline, avoid carers getting exhausted and reduce costs of emergency care. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Since the project began, the preparation and design objectives of the trial were addressed in order to allow the full clinical study to be conducted. The software system was designed following focus groups and interviews of over 150 mild dementia patients, carers and healthcare professionals. They were held within five EU countries to collect and understand their daily activities, familiarity with current technology, ethics/privacy/information sharing aspects and platform usage requirements and motivations.Utilising this information, the technical team have adopted and developed an existing patient support application that is specifically tailored to people with mild dementia. The system was tested and upgraded until it achieved the required design and performance, achieving milestone 3. At the same time the clinical team created and produced a Standard Operation Protocol (SOP) constituting uniformed study requirements and methods, and allowing the sites to proceed with requesting ethical approvals from their local ethics committees. Ethics applications were completed in all sites and approvals received in Sweden, Spain and Czech Republic, covering ethical approval of 82% of the planned study cohort, achieving milestone 1.Feasibility testing was conducted in Sweden and Spain, for both usability and feasibility of the prototype platform. The system was tested on ten dyads of users in both sites (total of 20 dyads) and the data was analysed by both centres. User results revealed an 81% user satisfaction, successfully completing the project’s feasibility study requirement (75% user satisfaction) and allowing the project to proceed with the full clinical pilot, achieving milestone 5.Following the feasibility study user comments, the IT platform tailored to mild dementia was tested and approved. Design Work package (WP2) and IT work package (WP3) were completed and the first SMART4MD enabled tablets were provided to the clinical sites, achieving milestone 4.Recruitment for the clinical study is open and ongoing in 3 clinical sites (BTH, CST and SAS); dyads are being randomised and assigned to the intervention and control groups. We are engaged in recruitment and expect to meet the targets.In this stage of the project (March 2018) project results available include: • “Accessibility Report”, “Focus group reports” and “Customisation guidance document” that were delivered to the EC as deliverables D2.1 D2.3 and D2.4 and can be used by interested parties such as “Cognitive and Learning Disabilities Accessibility Task Force” (COGA) to integrate our understanding of technological usage and preference of people with cognitive disabilities with new softer development or emerging standards. In March 2018 the cognitive accessibility task force of WCAG submitted a draft document of their “guidance for making content usable by people with cognitive and learning disabilities” which includes a footnote of acknowledgment to SMART4MD on testing the usability for people with cognitive disabilities and decline is present in the WCAG document.• Feasibility study report (Deliverable 4.1) includes details, data and results for both usability and feasibility of the platform.Data from the clinical phase of the project will become available next reporting period after 6 and 12 months follow-up with the participants. Preliminary results will become available after the analysis team receive the data from these visits.For the project dissemination, a public conference “ICT TECHNOLOGIES EMPOWERING PEOPLE WITH MILD DEMENTIA AND THEIR CARERS” was held (Madrid, February 2018), bringing together clinical and technological dementia experts to discuss ways of helping people with dementia and to disseminate and publicise the SMART4MD clinical study. This project was presented at more than 12 professional academic conferences and was promoted in more than 70 public events to engage patients, carers and the public and to increase the public's understanding of dementia. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) The contributions of this project and expected impacts that were mentioned in the original bid are all still relevant.We believe that everyday use of the SMART4MD platform will reduce the rate of cognitive decline in the first years of MD, and that they will participate in society longer, driven by a reduced rate of cognitive decline, while improving both their and their carer’s quality of life. By including case studies of the platform in each of our pilot countries this will show how the local healthcare systems could benefit from its use, and case studies would be combined with market analyses to design targeted business models, optimised for each country’s healthcare system.Additionally, interested parties such as “Cognitive and Learning Disabilities Accessibility Task Force” (COGA) and WCAG the standard adopted across the EU for accessibility and inclusion, may enable other providers that are designing accessible software and technological instruments for patients with mild dementia, Alzheimer’s and old age, to use our results to better engage and help users all around the world conference “ICT TECHNOLOGIES EMPOWERING PEOPLE WITH MILD DEMENTIA AND THEIR CARERS” Presenting SMART4MD Feasibilty Study SMART4MD App
