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 referred either the Dorset Stroke and Neurological services or the Acquired Brain Injury Rehabilitation Service. Both these settings are community-based rehabilitation centres in Dorset, UK. The National Health Service (NHS) based vocational services in the UK offer support with exploration of paid or voluntary work options, supporting retention in paid employment, support and guide employers about the employees' health condition and suggesting work restrictions and/ or reasonable adjustments considering the expectations of work role (Dorset Health Care 2022). The stroke specific vocational rehabilitation services often comprise neurological consultants, psychologists, OTs. OTs provide support with an initial assessment including functional capacity assessments and individualised client cantered interventions including work hardening and work conditioning. Literature stresses on early intervention to prevent job loss. However, not all stroke survivors are willing 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 been identified with return-to-work therapy goals.

Proposed Intervention: RehaCom Online is a computer based cognitive rehabilitation intervention 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 the RehaCom web-based platform using training modules for the attention, memory and executive function along with their routine therapy/ standard care.

Participants will be given free access to the platform on their preferred internet connected device. Participants will complete the intervention remotely at a time of their choosing, without a clinician present. Also, participants will have access to the researchers via RehaCom message function and/ or via email throughout the duration of intervention. They will be contacted by the researcher via telephone/ email part way through the intervention.

Participants will be asked to aim for a minimum intervention frequency two 30-minutes sessions per week for 5 weeks, for a total of 10 CBCR sessions recorded through the participant diary.

The maximum recommended dosage of CBCR is five 30-minute sessions per week over five weeks, totalling 25 sessions.

The 30-minutes include engaging in RehaCom training activities, and do not include breaks. Breaks however are encouraged where needed on top of the allocated 30 minutes of activity.

Primary objectives

• Identify factors for adherence to a five-week RehaCom intervention embedded within the community vocational rehabilitation pathway for young stroke survivors.
• Identify challenges to usage of RehaCom training, specific to this population and record adverse effects, if any
• Estimate recruitment and attrition rates, and reasons for declining participation or leaving the study early (where possible).
• Estimate person determined training frequency, intensity and duration, compared to recommended dose in this study and overall engagement with the intervention and data completeness.
• Determine the acceptability of the cognitive outcome measures, data collection methods.
• Determine potential inclusivity and diversity challenges.
• Explore clinician's acceptability and experience of using RehaCom when implemented as an additional cognitive intervention
• To develop an inclusive recruitment strategy for a definitive trial informed by the feasibility recruitment data.

Secondary objectives

• Explore changes in attention, memory and executive function pre and post intervention.
• Explore changes in perceived ability and perceived motivation to return to work for participants

Assessment and management of risk:

NICE guidance for stroke rehabilitation in adults (NICE, 2023) recommends providing education and support for people with stroke to help them understand the extent and impact of cognitive impairment. The guidance also suggests consideration of telerehabilitation based interventions when it is an option preferred by the stroke survivor and aligns with their rehabilitation goals. In accordance with the NICE guidance (2023), this trial aims to assess feasibility and acceptability of RehaCom training which is a computer-based cognitive rehabilitation intervention accessed remotely by stroke survivors for facilitation of cognitive recovery. This trial also aligns the prescription of RehaCom training to young stroke survivors who are on a pathway for vocational rehabilitation and have rehabilitation goals for returning to paid employment.

Existing literature supports safe and effective use of RehaCom training for cognitive recovery in people with stroke or acquired brain injuries.

Although, there are no known adverse effects to this intervention, participants within this trial will be advised to alert the research team or their treating clinical team or their general practitioner (GP) doctor in case they experience any adverse effects such as eye strain, cognitive fatigue, headaches or other unexpected side effects.

Eye Strain It is possible that stroke participants may experience eye strain when using the CBCR intervention. If this happens participants should let their usual care therapist know as well as a member of the research team.

Mitigation - If a participant experiences eye strain they can take longer breaks when doing the CBCR intervention, leave rest days between intervention sessions, and consider using 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 fatigue by having difficulty concentrating, overwhelming feeling of stress, irritability due to use of CBCR. If this happens participants should let their usual care therapist know as well as a member of the research team.

Mitigation - If a participant experiences cognitive/ mental fatigue they can take longer breaks when doing the CBCR intervention, leave rest days between intervention sessions, consider pacing and prioritisation of activities e.g. they can engage with CBCR intervention after a good night's sleep or during hours of the day when they are feeling their best.

Headaches/ Migraines It is possible that stroke participants may experience headaches or migraines due to use of CBCR. If this happens participants should let their usual care therapist know as well as a member of the research team.

Mitigation - If a participant experiences headaches/ migraines they can pause their CBCR intervention and complete it at another time when they are free of headaches. They may leave rest days between intervention sessions.

Other unexpected symptoms If a stroke participant experiences any other side effects which are not listed, they will be reported by participant during any correspondence or reported by the clinician working within the NHS service.

Mitigation - They can pause their participation in CBCR intervention and restart when they are free of symptoms, and with permission from of their usual care therapist and a member of the research team.

Stroke survivors: screening recruitment and consent process

Screening and Recruitment

The principal investigator (PI) will liaise with the consultation team at the NHS based community rehabilitation service regarding the list of referrals who are potentially eligible to participate in this feasibility study. Individuals identified by the on-site occupational therapy clinician and those who consent for contact will be contacted by the principal investigator (PG) via telephone or an email containing study information through the Participant Information sheet (PIS).

Those who express their willingness to participate in this study would receive a follow up telephone call/ Teams call from the PI in which they will be fully informed of the study protocol and have opportunity to ask questions.

Following this, participants will be invited to meet with the PI (visit 1) at a location of their choosing (home, clinic, online) in which they will be asked to provide written informed consent. If the meeting is held virtually, participants will be asked to post the signed participant agreement form in a prepaid envelope to the PI. Only once the PI is in receipt of the signed participant agreement form will participation progress.

This process will be performed in accordance with the ethical principles for involving people with cognitive impairment in research studies outlined by the NHS Health Research Authority. Participant's consent to participation will be reviewed if their mental capacity or cognitive abilities change during the study enrolment period. Participants will need to withdraw from the study if they lose mental capacity during the intervention period.

Occupational Therapy clinicians: recruitment and consent process

PI 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 this study will provide their contact details to the PI through MS forms. OT clinicians willing to participate will receive PIS and participant agreement form via email. They will 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 consent for participation. Also, it will be made clear that deciding to take part or not take part will have no impact on the stroke survivor's rehabilitation or the clinician's work.

For stroke participants:

Inclusion criteria

• Ages 18-65 (working age)
• Score of 12 or more on a specific test of thinking called Behavioural Assessment of Dysexecutive Syndrome (BADS)
• Referred to NHS based services with a goal to return to work
• Can do assessments in English and use a computer
• Have a stable internet connection to access training

Exclusion criteria

• Have seizures
• Have vision problems specific to stroke
• Have trouble understanding English language due to their stroke symptoms
• Lack capacity to provide consent for participation

Inclusion and Exclusion criteria for Occupational Therapy Clinician participants:

Working in participating community rehabilitation services for stroke and willing to be involved in this study.