1 Eriksson G, et al. BMJ Open 2022;12:e058748. doi:10.1136/bmjopen-2021-058748 Open access Study protocol of a non-randomised controlled trial evaluating the effectiveness of the F@ce 2.0 programme: a person-centred, ICT- supported and interdisciplinary rehabilitation intervention after stroke Gunilla Eriksson , 1 Malin Tistad, 1,2 Marie Elf , 2 Uno Fors, 3 Lena von Koch , 1,4 Charlotte Ytterberg , 1,5 Susanne Guidetti 1,5 To cite: Eriksson G, Tistad M, Elf M, et al. Study protocol of a non-randomised controlled trial evaluating the effectiveness of the F@ce 2.0 programme: a person-centred, ICT- supported and interdisciplinary rehabilitation intervention after stroke. BMJ Open 2022;12:e058748. doi:10.1136/ bmjopen-2021-058748 ► Prepublication history and additional supplemental material for this paper are available online. To view these fles, please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2021-058748). Received 27 October 2021 Accepted 17 July 2022 For numbered affliations see end of article. Correspondence to Susanne Guidetti; susanne.guidetti@ki.se Protocol © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ABSTRACT Introduction Knowledge is missing on use of information and communication technology (ICT), for example, mobile phones/tablets in rehabilitation after stroke. F@ ce 2.0 is a person-centred, interdisciplinary intervention supported by ICT. The components of F@ce 2.0 intend to increase performance in daily activities and participation in everyday life for patients with stroke and their signifcant others. Based on previous feasibility studies, a full-scale evaluation is planned in Sweden. The aim is to implement and evaluate F@ce 2.0, regarding performance of daily activities and participation in everyday life, in comparison with ordinary rehabilitation among persons who have had stroke and signifcant others. Second, to increase knowledge about how the programme leads to a potential change by studying the implementation process and mechanisms of impact. Methods and analysis Twelve rehabilitation teams (intervention n=7; control n=5) will recruit patients (n=160) who receive rehabilitation at home after stroke and their signifcant others. F@ce 2.0 is an 8-week intervention where patients, together with the team, formulate three activity goals regarding what they need and want to do in daily lives. The patients will receive short messages service (SMS) each morning reminding about goals, and in the evening to rate their performance during the day. Primary outcomes for patients: self-effcacy measured by the Self- Effcacy Scale; perceived performance in daily activities measured by the Canadian Occupational Performance Measure. Signifcant others: perceived caregiver burden measured by Caregiver Burden Scale. Qualitative interviews with team members delivering, patients receiving intervention and signifcant others will explore experiences of F@ce 2.0. A process evaluation applying a case-study design using mixed methods will be conducted. Ethics and dissemination Approved by the Swedish Ethical Review Authority, Stockholm. Knowledge will be created for using ICT for rehabilitation of people after stroke in self-selected activities. Dissemination will include peer-reviewed publications, presentations at conferences, and information to stakeholders. Trial registration number details NCT04351178. INTRODUCTION Stroke is one of the major public health diseases internationally and in Sweden. The Swedish National Board of Health and Welfare reported that in 2017 approximately 25 800 people had had stroke. 1 For survivors, stroke often leads to decreased functioning in everyday life due to impairments, activity limitations and participation restrictions. In addition, significant others are at risk of depression, caregiver burn-out, isolation and decreased life satisfaction. 2 Changes in everyday life may, therefore, occur for the persons who have had a stroke and their families 3 and there is often a need for reha- bilitation. In previous studies, being involved in engaging daily activities has been shown to contribute to a positive change in the recovery process. 4 Engaging activities contribute to an intense feeling of participating in activities and a sense of meaning and purpose which make life worth living. 5 Creating experiences of performing daily activities in the reha- bilitation process after stroke is important since successfully performed activities will STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ The study is a full-scale trial with a nested process evaluation of a theory based, and feasibility tested rehabilitation intervention after stroke. ⇒ Different stakeholders were involved in the devel- opment of the research project highlighting several perspectives. ⇒ A limitation is the non-randomised design of the trial. on February 15, 2023 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2021-058748 on 4 August 2022. Downloaded from