Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 28, 2025
Date Accepted: Aug 25, 2025
Scaling EUROpean citizen driven transferable and transformative digital health (SEURO): Protocol for an Effectiveness-Implementation Hybrid Trial of a digital health platform to support multimorbidity self-management
ABSTRACT
Background:
Multimorbidity, the presence of two or more chronic conditions, is becoming increasingly prevalent worldwide, resulting in significant impact on healthcare systems. For people with multiple conditions, self-management can be challenging, requiring engagement in a range of tasks. Digital health platforms have been widely acknowledged as having potential to enhance self-management practices for those with chronic conditions. However, there are limited longitudinal studies exploring the effectiveness of digital health platforms that support multimorbidity self-management, or issues relating to their implementation and scalability in practice.
Objective:
The aim of this study is to determine the effectiveness and implementation of a digital health platform, ProACT with support services including clinical triage and a care network (consisting of informal and formal carers and healthcare professionals), compared to use of the platform without support services and compared to standard care.
Methods:
An Effectiveness-Implementation type 1 hybrid study will be conducted across 3 European countries. A total of 720 older adults aged 65 or older with multimorbidity (two or more of following: diabetes, a chronic respiratory disease, chronic heart failure, and chronic heart disease) will be recruited and randomised into one of 3 trial arms. Those in Trial Arm 1 will be invited to have up to 5 care network members participate with them, resulting in a maximum of 1500 care network participants. Effectiveness will be assessed through a 3-arm pragmatic randomised controlled trial while implementation issues will be addressed via a process evaluation. Primary outcomes for participants with multimorbidity are quality of life and healthcare utilisation, while secondary outcomes focus on the potential of the ProACT platform to support multimorbidity self-management (e.g. self-efficacy, usability, engagement, symptom stabilisation). Primary outcomes for informal carers in the care network include caring burden, while secondary outcomes for all care network members include usability, engagement, satisfaction, and overall experiences with ProACT. Additional outcomes related to the process evaluation include the reach, uptake, and fidelity of implementation of ProACT and the way organisations implement and deliver ProACT, how they differ in this regard, and the factors underpinning these differences. A range of qualitative and quantitative data will be collected and analysed to assess these outcomes.
Results:
Enrolment on the trial began in September 2022 and the trial is anticipated to end by December 2025. Trial outcomes will be submitted for publication in 2025.
Conclusions:
The generation of evidence-based support for the routine use of the ProACT platform in applied settings would represent considerable impact. With healthcare services under increasing strain and traditionally designed to support those with single morbidities, it is more important than ever to develop actionable insights and resources that can empower persons with multimorbidity to self-manage their complex care needs at home, with the support of their carers. Clinical Trial: ISRCTN34134007
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