SEURO -SEURO supports self-management of multiple chronic conditions using digital health technology

Description

Globally, populations are ageing as people live longer. Multimorbidity, which is defined as having two or more chronic conditions is of particular concern, with approximately 50 million people in Europe with multimorbidity. Self-management is a necessary part of living with a chronic condition, however for older adults with multimorbidity, this is challenging since it requires involvement in numerous activities like symptom monitoring, following lifestyle guidelines, managing medications, and navigating healthcare systems. There is a need to provide well-coordinated, person-centred care for older adults with multimorbidity to help them successfully self-manage and maintain an active and healthy life.

Digital health technologies have significant potential to promote health self-management at home, to improve care integration, and minimise the strain of self-management. However, digital health technologies are often designed without older adults in mind as potential users, and without input from older adults, which can negatively impact acceptance and adoption.

This project examines the use of a digital health platform – ProACT – for older adults with multimorbidity to help them self-manage their care and remain living independently in their community for as long as possible. The platform was initially created under the European Union funded Horizon 2020 ProACT project (2016-2019), and was developed in DkIT. A strong emphasis was placed on involving older adults with multimorbidity and their carers in the development process. This involved interviews and focus groups with older adults with multimorbidity and those who care for them (informal carers, formal carers, healthcare professionals), to understand their needs and challenges. This was followed by a series of co-design workshops with these stakeholders to design the ProACT platform. The platform was also developed using accessibility guidelines. A 12-month proof-of-concept trial took place in Ireland and Belgium from 2018 -2019 with 120 older adults with multimorbidity and 75 members of their care networks to explore experiences and engagement with the platform. Findings from the trial were very positive in relation to the use of the platform by older adults, with high levels of user engagement (participants monitored symptoms on average 2-3 times a day), retention (only 8 participants withdrew over the course of the year) and positive outcomes (such as health improvements, improved self-management). A total of 409 people participated in the various stages of the ProACT project.

The SEURO Horizon 2020 project (2021-2024) is a continuation of the ProACT project. The platform is currently being evaluated in Effectiveness-Implementation Hybrid (EIH) trials with older adults with multimorbidity and their care networks in Ireland, Sweden and Belgium. The aim of the trials is to assess the effectiveness of the ProACT platform on quality of life and healthcare utilisation through a 3-arm pragmatic randomised control trial, as well as to explore barriers and facilitators to implementing this type of digital health solution in practice. The control group receive usual care. Arm 1 receives the ProACT app with full features as well as a range of digital devices for measuring health and wellbeing data; they receive alerts if their health measures fall outside of the recommended thresholds, they also receive calls from a triage nursing service based on these alerts, and have the opportunity to add people to their care network. Education is also personalised within their app. Arm 2 receives the basic features of the ProACT app as well as the digital devices, however they do not receive alerts, triage, or care network. In total, 720 older adults will be recruited (240 per trial site). In Ireland, there are currently 74 participants enrolled (mean age 74 ± 5.2, 61% male); 84.5% of participants have reported a heart condition, 42.3% have reported a diabetes diagnosis, and 53.5% have a respiratory condition. Twenty-four of the participants enrolled to date have been allocated to the control group, 23 are allocated to Arm 1 and 24 are allocated to Arm 2.

SEURO is also developing and implementing three new digital self-assessment tools: ProTransfer, ProBCF-C and ProInsight as part of the the ProACT platform. ProTransfer and ProBCF-C will respectively evaluate organisational readiness to implement, transfer and scale a digital health solution such as ProACT in practice across an organisation or service, providing tailored guidance to help improve readiness levels and likelihood of positive behaviour change with end-users (e.g. improve engagement with the platform). The ProInsight tool will help evaluate effectiveness of a digital solution at both end user level (e.g. impact on health, well-being and quality of life) and organisation or service level (e.g. cost effectiveness). (Further detail on these tools is provided in the Step 1 section below).

The project, funded by the European Commission under the Horizon 2020 programme, is coordinated by Dr John Dinsmore in Trinity College Dublin and involves 12 partners across five EU Member states (Ireland, Belgium, Italy, Sweden and Austria). Dr Julie Doyle in NetwellCASALA, DkIT is leading the trials in Ireland.

Aim of Initiative

The overall aim of SEURO is to assess the critical elements required for any EU region to be ready to successfully scale-up innovative, people-centric digital health and social care solutions for the management of multiple diseases. The SEURO trial aims to assess the impact of the ProACT digital health solution on quality of life and healthcare utilisation.

Who is it aimed at

Older adults with multimorbidity, including associated co-morbidities with a focus on diabetes, chronic heart disease/failure and chronic respiratory diseases.

3 Steps critical to success

1. The first step was to develop and incorporate three new digital self-assessment tools into the ProACT platform: ProTransfer, ProBCF-C and ProInsight. The ProTransfer tool helps healthcare organisations evaluate their readiness to implement and transfer digital health solutions (e.g. at local, regional or national levels). The ProBCF-C digital assessment tool helps organisations evaluate whether the digital solution has been developed as a Digital Behavioural Change Health Intervention to support positive behaviour changes with users. The ProBCF-C is based on the conceptual behavioural change framework developed in the earlier Horizon2020 ProACT project. The ProInsight assessment tool integrates a new set of analytics for risk categorisation and prediction. This tool estimates the future impact of the ProACT platform on end users (e.g. patients) and healthcare organisations/services by combining existing population data with new data arising from SEURO trials.
2. The next step was to evaluate the new ProACT platform. Effectiveness implementation hybrid trials are currently underway with older adult participants with multimorbidity and their care networks across three different European trial sites in Ireland, Belgium and Sweden. A further Inductive-Simultaneous exploratory (ISE) trial will be conducted with 50 older people with multimorbidity and their care networks in Italy to explore how the use of the tools and ProACT may inform transferability and procurement processes for digital health technologies across European organisations and regions.
3. The third step involves the development of health economic, commercial and business development models to support exploitation of the SEURO tools and the ProACT platform at European and International levels.

3 Challenges in Planning / Delivery

1. Re-organising project activities and timelines due to COVID-19. During the first few months of SEURO we had planned to engage older adults in co-design workshops again, to design new features for the ProACT platform as well as refining the existing platform. Given that co-design workshops involve hands-on activities, we wanted to do these in-person. However, with COVID-19, and as our participants are living with complex chronic conditions, it was not safe to do so. To overcome this, we went back through all of the data from the ProACT trials that ended in 2019, reviewed feedback from the participants and re-watched videos we had recorded during usability testing sessions with participants throughout the trial. This allowed us to begin refining the platform to prevent any significant software development delays, while keeping the user at the centre of the process. We then conducted the co-design sessiAons with older adults to design new features approximately 9 months later than anticipated.
2. Recruitment of older adult participants during the ongoing SEURO trial has been slow and challenging. The inclusion criteria for the trial are strict (people aged 65 and over with two or more of the conditions diabetes, heart failure, heart disease, and chronic respiratory disease), which has contributed to the challenge. Furthermore, the trial started during winter 2022, which made engagement with healthcare organisations who were supporting the recruitment very difficult, given the significant challenges being faced by healthcare professionals over the clinical winter. This has meant that we have had to adjust the project timeline to extend it by 6 months to ensure we recruit the number of people required for the trial.
3. A further issue was navigating legal and compliance issues. Significant attention was paid to complying with GDPR regulations throughout ProACT and SEURO, with detailed data protection impact assessments being developed and reviewed by legal teams. During the SEURO project, however, details of the new Medical Device Regulation (MDR) emerged and with it a lack of clarity on whether / how this impacts on the development of digital health solutions that are in the research rather than commercial space. Much time was spent trying to get clarity on this issue. We set up an advisory board that included legal and regulation experts, provided a lot of detail on the research project, the platform and the trials and received a legal opinion that research projects do not fall under MDR (though any future commercialisation of the platform would). While this was a very time-consuming process, significant learnings were gained.

3 Outcomes / Benefits

1. By developing tools to support the transferability of ProACT, the SEURO project can create benefits for a wider cohort of people with multimorbidity and their families. Better adoption of the ProACT platform may yield a number of benefits including: empowering people with multimorbidity to actively manage their own health, provide information and guidance on how individuals can improve their health, and encourage the adoption of behaviours which improve health.
2. The project has potential to improve the efficiency and efficacy of health systems in managing multimorbidity. Potential improvements include: providing guidance to healthcare organisations and providers on how to effectively implement solutions such as ProACT, improving healthcare organisation knowledge to advance adoption of digital health and related assistive technologies, and optimising transferability of digital health solutions within and across EU regions.
3. From an economic perspective, providing evidence for the scaling up of digital health solutions across Europe via the trialling of the ProACT platform could potentially result in lower healthcare spending for chronic disease management. Developing tools to support organisations to better adopt and transfer digital health solutions such as the ProACT platform could empower people to self-manage their health reducing unnecessary healthcare utilisation and keep people living at home longer, thus reducing healthcare spending on residential care.