Computer Based Cognitive Rehabilitation (CBCR) Intervention for Young Stroke Survivors' Return to Work

Details of the study: This feasibility study will involve young stroke survivors referredeither the Dorset Stroke and Neurological services or the Acquired Brain InjuryRehabilitation Service. Both these settings are community‐based rehabilitation centres inDorset, UK. The National Health Service (NHS) based vocational services in the UK offersupport with exploration of paid or voluntary work options, supporting retention in paidemployment, support and guide employers about the employees' health condition andsuggesting work restrictions and/ or reasonable adjustments considering the expectationsof work role (Dorset Health Care 2022). The stroke specific vocational rehabilitationservices often comprise neurological consultants, psychologists, OTs. OTs provide supportwith an initial assessment including functional capacity assessments and individualisedclient cantered interventions including work hardening and work conditioning. Literaturestresses on early intervention to prevent job loss. However, not all stroke survivors arewilling or able to consider return to work early in their recovery (Sinclair et al.,2013). Hence, the authors of this study aim to recruit participants after they have beenidentified with return‐to‐work therapy goals.Proposed Intervention: RehaCom Online is a computer based cognitive rehabilitationintervention consisting of training modules for domains of cognition namely attention,memory and executive function and training for visual field deficits.For this feasibility trial, participants will engage with a CBCR intervention via theRehaCom web‐based platform using training modules for the attention, memory and executivefunction along with their routine therapy/ standard care.Participants will be given free access to the platform on their preferred internetconnected device. Participants will complete the intervention remotely at a time of theirchoosing, without a clinician present. Also, participants will have access to theresearchers via RehaCom message function and/ or via email throughout the duration ofintervention. They will be contacted by the researcher via telephone/ email part waythrough the intervention.Participants will be asked to aim for a minimum intervention frequency two 30‐minutessessions per week for 5 weeks, for a total of 10 CBCR sessions recorded through theparticipant diary.The maximum recommended dosage of CBCR is five 30‐minute sessions per week over fiveweeks, totalling 25 sessions.The 30‐minutes include engaging in RehaCom training activities, and do not includebreaks. Breaks however are encouraged where needed on top of the allocated 30 minutes ofactivity.Primary objectives 1. Identify factors for adherence to a five‐week RehaCom intervention embedded withinthe community vocational rehabilitation pathway for young stroke survivors. 2. Identify challenges to usage of RehaCom training, specific to this population andrecord adverse effects, if any 3. Estimate recruitment and attrition rates, and reasons for declining participation orleaving the study early (where possible). 4. Estimate person determined training frequency, intensity and duration, compared torecommended dose in this study and overall engagement with the intervention and datacompleteness. 5. Determine the acceptability of the cognitive outcome measures, data collectionmethods. 6. Determine potential inclusivity and diversity challenges. 7. Explore clinician's acceptability and experience of using RehaCom when implementedas an additional cognitive intervention 8. To develop an inclusive recruitment strategy for a definitive trial informed by thefeasibility recruitment data.Secondary objectives 9. Explore changes in attention, memory and executive function pre and postintervention. 10. Explore changes in perceived ability and perceived motivation to return to work forparticipantsAssessment and management of risk:NICE guidance for stroke rehabilitation in adults (NICE, 2023) recommends providingeducation and support for people with stroke to help them understand the extent andimpact of cognitive impairment. The guidance also suggests consideration oftelerehabilitation based interventions when it is an option preferred by the strokesurvivor and aligns with their rehabilitation goals. In accordance with the NICE guidance(2023), this trial aims to assess feasibility and acceptability of RehaCom training whichis a computer‐based cognitive rehabilitation intervention accessed remotely by strokesurvivors for facilitation of cognitive recovery. This trial also aligns the prescriptionof RehaCom training to young stroke survivors who are on a pathway for vocationalrehabilitation and have rehabilitation goals for returning to paid employment.Existing literature supports safe and effective use of RehaCom training for cognitiverecovery in people with stroke or acquired brain injuries.Although, there are no known adverse effects to this intervention, participants withinthis trial will be advised to alert the research team or their treating clinical team ortheir general practitioner (GP) doctor in case they experience any adverse effects suchas eye strain, cognitive fatigue, headaches or other unexpected side effects.Eye Strain It is possible that stroke participants may experience eye strain when usingthe CBCR intervention. If this happens participants should let their usual care therapistknow as well as a member of the research team.Mitigation ‐ If a participant experiences eye strain they can take longer breaks whendoing the CBCR intervention, leave rest days between intervention sessions, and considerusing a larger device e.g. if they are using a phone or table to try to use a computer(where possible).Cognitive fatigue It is possible that stroke participants may experience mental fatigueby having difficulty concentrating, overwhelming feeling of stress, irritability due touse of CBCR. If this happens participants should let their usual care therapist know aswell as a member of the research team.Mitigation ‐ If a participant experiences cognitive/ mental fatigue they can take longerbreaks when doing the CBCR intervention, leave rest days between intervention sessions,consider pacing and prioritisation of activities e.g. they can engage with CBCRintervention after a good night's sleep or during hours of the day when they are feelingtheir best.Headaches/ Migraines It is possible that stroke participants may experience headaches ormigraines due to use of CBCR. If this happens participants should let their usual caretherapist know as well as a member of the research team.Mitigation ‐ If a participant experiences headaches/ migraines they can pause their CBCRintervention and complete it at another time when they are free of headaches. They mayleave rest days between intervention sessions.Other unexpected symptoms If a stroke participant experiences any other side effectswhich are not listed, they will be reported by participant during any correspondence orreported by the clinician working within the NHS service.Mitigation ‐ They can pause their participation in CBCR intervention and restart whenthey are free of symptoms, and with permission from of their usual care therapist and amember of the research team.Stroke survivors: screening recruitment and consent processScreening and RecruitmentThe principal investigator (PI) will liaise with the consultation team at the NHS basedcommunity rehabilitation service regarding the list of referrals who are potentiallyeligible to participate in this feasibility study. Individuals identified by the on‐siteoccupational therapy clinician and those who consent for contact will be contacted by theprincipal investigator (PG) via telephone or an email containing study informationthrough the Participant Information sheet (PIS).Those who express their willingness to participate in this study would receive a followup telephone call/ Teams call from the PI in which they will be fully informed of thestudy protocol and have opportunity to ask questions.Following this, participants will be invited to meet with the PI (visit 1) at a locationof their choosing (home, clinic, online) in which they will be asked to provide writteninformed consent. If the meeting is held virtually, participants will be asked to postthe signed participant agreement form in a prepaid envelope to the PI. Only once the PIis in receipt of the signed participant agreement form will participation progress.This process will be performed in accordance with the ethical principles for involvingpeople with cognitive impairment in research studies outlined by the NHS Health ResearchAuthority. Participant's consent to participation will be reviewed if their mentalcapacity or cognitive abilities change during the study enrolment period. Participantswill need to withdraw from the study if they lose mental capacity during the interventionperiod.Occupational Therapy clinicians: recruitment and consent processPI will share the digital study recruitment poster with the Occupational Therapy (OT)clinicians via the OT stakeholder group. OT clinicians willing to be involved in thisstudy will provide their contact details to the PI through MS forms. OT clinicianswilling to participate will receive PIS and participant agreement form via email. Theywill have the opportunity to meet the PI via online meeting and discuss the project.Those consenting for participation will have at least 48 hours to reflect their consentfor participation. Also, it will be made clear that deciding to take part or not takepart will have no impact on the stroke survivor's rehabilitation or the clinician's work.