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.
