Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB)

Background: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention. Methods/design: SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n = 30) with usual care + peer befriending (n = 30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n = 20) and significant others (n = 10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5 L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI). Discussion: This study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial. Trial registration: ClinicalTrials.gov identifier NCT02947776, registered 28th October 2016

Blinding participants and assessors in a feasibility randomised controlled trial of peer-befriending for people with aphasia post-stroke

Background and aims: In behavioural interventions, blinding participants to intervention versus control conditions is problematic, as is blinding assessors to participants’ group allocation. When participants are provided with information about the intervention to be tested, they will know whether they are in the intervention or the control arm of the study. This is particularly problematic in psychological interventions where people who may already be distressed or anxious are likely to become even more distressed when they realise they are in the control arm of a study. To minimise potential threats to validity and maintain lack of bias, we took a number of steps in the SUpporting well-being through PEeR-Befriending (SUPERB) feasibility trial for people with aphasia to ensure blinding. This presentation will report on these steps and evaluate their effectiveness. Methods: SUPERB is a single blind, mixed methods, parallel group phase II randomised controlled trial (RCT) comparing usual care+peer-befriending (n = 30) versus usual care (n = 30), starting at discharge from hospital. Little is known about what usual care for psychological support after stroke-aphasia constitutes, and this study will document the services the participants receive in their area for both groups. A modified two-stage consent design has been adopted (Campbell, Peters, Grant, Quilty, & Dieppe, 2005; Torgerson & Roland, 1998), as highlighted in the Medical Research Council framework for complex interventions (Craig et al., 2008). In the first stage, all participants consent to take part in a study on adjustment post-stroke and have their data collected at three time points (i.e., baseline, 4 months, and 10 months). They know they may be compared to other people in the study receiving different packages of care, but are blind to the fact that the study tests a specific intervention (peer-befriending). Following baseline assessments, participants are randomised to either usual care+peer-befriending or usual care. At this point, a second stage consent to take part in the intervention is completed with those participants allocated to the peer-befriending arm. Rate of consent at both stages is monitored. Blinded researchers (assessors) complete assessments for both groups at 4 months and 10 months. Strategies to maintain blinding of assessors include the following: the use of scripts during assessments and asking the participants not to reveal what care they have received; unblinded researcher organising post-randomisation appointments, so that assessors cannot become unblinded by partners/carers of people with aphasia revealing information; and management of the work environment (separate office space, different telephones, and no physical or electronic access to sensitive data). Instances of unblinding are recorded. Results: The trial is currently underway. Thirty-eight of 60 participants have been recruited and 27 have been randomised. The two-stage consent process has been largely successful. No instances of unblinding by participants or researchers have been recorded. Near misses (n = 4) have been recorded for the blinded researchers. These are unrelated to the assessments with participants but rather workplace factors (e.g., use of email, shared calendars, and overhearing telephone conversations). Conclusions: Blinding of participants and researchers is critical to the success of a RCT. This paper raises and discusses a range of processes including a modified two-stage consent process and careful preparation and monitoring of participants, researchers, and workplace factors – which are all important steps to reducing the possibility of unblinding

A concise patient reported outcome measure for people with aphasia: the aphasia impact questionnaire 21

Background: There are many validated and widely used assessments within aphasiology. Few, however, describe language and life with aphasia from the perspective of the person with aphasia. Across healthcare, patient experience and user involvement are increasingly acknowledged as fundamental to person-centred care. As part of this movement, Patient Reported Outcome Measures (PROMs) are being used in service evaluation and planning. Aims: This paper reports the quantitative aspects of a mixed methods study that developed and validated a concise PROM, the Aphasia Impact Questionnaire (AIQ), co-produced with People with Aphasia (PWA). Methods & Procedures: The AIQ was developed within the social model of disability and all stages of the development of the AIQ were performed in partnership with PWA. It was adapted from a pre-existing and lengthier PROM for PWA, the Communication Disability Profile. The first iterations of the AIQ focused on domains of communication, participation and well-being/emotional state. Subsequently the AIQ was extended to include additional items relating to reading and writing (AIQ-21). The research design was iterative. Initially, concurrent validity, internal consistency, and sensitivity of the AIQ-prototype were obtained. The AIQ-prototype was modified to become the AIQ-21. Statistical testing with a new group of PWA was performed, investigating internal consistency and concurrent validity of the AIQ-21. Outcomes & Results: Results for both the AIQ-prototype and AIQ-21 showed statistically significant concurrent validity and good internal consistency. Repeated measurement using the AIQ-prototype demonstrated statistically significant change after PWA accessed a community intervention. Conclusions: The AIQ-21 is a PROM that has great potential to be one of the core set of aphasia tests for clinical and research use. Results can be used alongside language assessment to enable person-centred goal setting and partnership working for people with aphasia

“Loneliness can also kill:” a qualitative exploration of outcomes and experiences of the SUPERB peer-befriending scheme for people with aphasia and their significant others

People with aphasia post-stroke are at risk for depression and social isolation. Peer-befriending from someone with similar experiences may promote wellbeing and provide support. This paper explored the views of people with aphasia and their significant others about peer-befriending. We conducted a qualitative study within a feasibility trial (SUPERB) on peer-befriending for people with post-stroke aphasia and low levels of distress. Of the 28 participants randomised to the intervention, semi-structured in-depth interviews were conducted with 10 purposively selected people with aphasia (at both 4- and 10-months post-randomisation) and five of their significant others (at 4-months). Interviews were analysed using Framework Analysis. Participants and their significant others were positive about peer-befriending and identified factors which influenced their experience: the befrienders' personal experience of stroke and aphasia, their character traits and the resulting rapport these created, the conversation topics they discussed and settings they met in, and the logistics of befriending, including planning visits and negotiating their end. Interviewees also made evaluative comments about the befriending scheme. Peer-befriending was an acceptable intervention. Benefits for emotional wellbeing and companionship were reported. The shared experience in the befriending relationship was highly valued.Implications for RehabilitationThe lived experience of stroke and aphasia of befrienders was highly valued by people with aphasia receiving peer-befriending.Training, regular supervision, and support for befrienders with practicalities such as organising visits ensured the befriending scheme was perceived as straightforward and acceptable by befriendees.Those receiving peer-befriending would recommend it to others; they found it beneficial, especially in terms of emotional wellbeing and companionship

“For them and for me”: a qualitative exploration of peer befrienders’ experiences supporting people with aphasia in the SUPERB feasibility trial

Peer-befriending, where support is offered by someone with shared lived experience, is an intervention that may facilitate successful adjustment in people experiencing post-stroke aphasia. This paper explores the experiences of the peer-befrienders. People with aphasia were recruited as peer-befrienders within the SUPERB trial investigating befriending for people with post-stroke aphasia. The intervention comprised six visits over three months. Peer-befrienders were matched with at least one befriendee and received training and ongoing supervision. They were invited to participate in in-depth interviews which were analysed using framework analysis. All 10 befrienders participated in interviews, reporting on 19 matches. Seven main themes emerged: content of the sessions; befriender-befriendee relationship; negotiating the visits; handling boundaries and endings; positive impact of the befriending for befrienders and befriendees; and beliefs about the nature and value of peer support. While befrienders described challenges, such as negotiating journeys and witnessing distress, the role was perceived as a "secure challenge" due to the support and training received. Befrienders perceived the role as enjoyable and rewarding, and felt they were making a positive difference. They were unanimous in believing that people with aphasia can offer unique and valuable support to others with aphasia. ClinicalTrials.gov identifier NCT02947776, registered 28th October 2016.Implications for rehabilitationPeople with lived experience of stroke and aphasia were able to offer emotional and social peer support to others with aphasia within the SUPERB trial.Although there were challenges, peer befrienders perceived the role as rewarding and satisfying.Peer befrienders valued the training and ongoing supervision and support they received to deliver the intervention.It is recommended that rehabilitation professionals considering offering peer-befriending schemes provide training and ongoing supervision to support peer-befrienders fulfil their role, as well as practical support with, e.g., arranging visits

Supporting wellbeing through peer-befriending (SUPERB) for people with aphasia: A feasibility randomised controlled trial

Objective: To determine the feasibility and acceptability of peer-befriending, for people with aphasia. Design: Single-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending. Participants and setting: People with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community. Intervention: Six 1-hour peer-befriending visits over three months. Main measures: Feasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending. Results: Of 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, −2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few ( n = 10, none for significant others and peer-befrienders) and unrelated. Conclusions: SUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial. Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776 Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, strok

‘Emotion is of the essence. … Number one priority’: A nested qualitative study exploring psychosocial adjustment to stroke and aphasia

Background: Stroke and aphasia can have a profound impact on people’s lives, and depression is a common, frequently persistent consequence. Social networks also suffer, with poor social support associated with worse recovery. It is essential to support psychosocial wellbeing post-stroke, and examine which factors facilitate successful adjustment to living with aphasia. Aims: In the context of a feasibility randomised controlled trial of peer-befriending (SUPERB), this qualitative study explored adjustment for people with aphasia in the post-acute phase of recovery, a phase often neglected in previous research. Method and procedures: Semi-structured interviews were conducted with 20 people with aphasia and ten significant others, who were purposively sampled from the wider group of 56 people with aphasia and 48 significant others. Interviews took place in participants homes; they were analysed using Framework Analysis. Outcomes and results: Participants with aphasia were 10 women and 10 men; their median (IQR) age was 70 (57.5-77). Twelve participants had mild aphasia, eight moderate-severe. Significant others were six women and four men with a median (IQR) age of 70.5 (43-79). They identified a range of factors that influenced adjustment to aphasia post-stroke. Some were personal resources, including: mood and emotions; identity/sense of self; attitude and outlook; faith and spirituality; moving forward. Significant others also talked about the impact of becoming carers. Other factors were external sources of support, including: familial and other relationships; doctors, nurses and hospital communication; life on the ward; therapies and therapists; psychological support, stroke groups and community and socialising. Conclusions and implications: To promote adjustment in the acute phase, hospital staff should prioritise the humanising aspects of care provision. In the post-acute phase, clinicians play an integral role in supporting adjustment and can help by focusing on relationship-centred care, monitoring mental health, promoting quality improvement across the continuum of care and supporting advocacy

SUpporting wellbeing through PEeR-Befriending (SUPERB) feasibility trial: fidelity of peer-befriending for people with aphasia.

Objective To evaluate systematically the fidelity of a peer-befriending intervention for people with aphasia. Design SUpporting wellbeing through Peer-befriending (SUPERB) was a feasibility randomised controlled trial comparing usual care to usual care +peer-befriending. This paper reports on the fidelity of all intervention aspects (training and supervision of providers/befrienders; intervention visits) which was evaluated across all areas of the Behaviour Change Consortium framework. Setting Community. Participants People with aphasia early poststroke and low levels of distress, randomised to the intervention arm of the trial (n=28); 10 peer-befrienders at least 1-year poststroke. Intervention Peer-befrienders were trained (4–6 hours); and received regular supervision (monthly group while actively befriending, and one-to-one as and when needed) in order to provide six 1-hour peer-befriending visits over 3 months. Main measures Metrics included number and length of training, supervision sessions and visits. All training and supervision sessions and one (of six) visits per pair were rated against fidelity checklists and evaluated for inter-rater and intrarater reliability (Gwets AC1 agreement coefficient). Per-cent adherence to protocol was evaluated. Results All peer-befrienders received 4–6 hours training over 2–3 days as intended. There were 25 group supervision sessions with a median number attended of 14 (IQR=8–18). Twenty-six participants agreed (92.8%) to the intervention and 21 (80.8%) received all six visits (median visit length 60 min). Adherence was high for training (91.7%–100%) and supervision (83%–100%) and moderate-to-high for befriending visits (66.7%–100%). Where calculable, inter-rater and intrarater reliability was high for training and supervision (Gwets AC1 >0.90) and moderate-to-high for intervention visits (Gwets AC1 0.44–1.0). Conclusion Planning of fidelity processes at the outset of the trial and monitoring throughout was feasible and ensured good-to-high fidelity for this peer-befriending intervention. The results permit confidence in other findings from the SUPERB trial

Microtubules gate tau condensation to spatially regulate microtubule functions.

Tau is an abundant microtubule-associated protein in neurons. Tau aggregation into insoluble fibrils is a hallmark of Alzheimer's disease and other types of dementia1, yet the physiological state of tau molecules within cells remains unclear. Using single-molecule imaging, we directly observe that the microtubule lattice regulates reversible tau self-association, leading to localized, dynamic condensation of tau molecules on the microtubule surface. Tau condensates form selectively permissible barriers, spatially regulating the activity of microtubule-severing enzymes and the movement of molecular motors through their boundaries. We propose that reversible self-association of tau molecules, gated by the microtubule lattice, is an important mechanism of the biological functions of tau, and that oligomerization of tau is a common property shared between the physiological and disease-associated forms of the molecule

Sacred work? Exploring spirituality with therapists working with stroke patients with aphasia

Speech and language therapists (SLT), occupational therapists (OT) and physiotherapists (PT) on stroke rehabilitation wards have long worked in an holistic way, with the client at the centre of their interventions. However, if we consider our clients to be tripartite beings, comprising body, mind and spirit, do we, in fact, give credence to the spiritual dimension? Are there particular considerations in this regard when we consider those patients who present with communication difficulties following a stroke? Are we able to facilitate expressions of spiritual distress/need in our clients with aphasia who have difficulty verbalising their thoughts and, if so, is it our role to do so? As part of a larger study exploring stories of spirituality with people with aphasia, I interviewed members of the multidisciplinary team on an acute stroke ward. I wanted to explore their understanding of their professional role vis-à-vis spirituality. This article focusses on some of the themes which emerged in the interviews with the therapists on the stroke ward: an OT, SLT and PT. Using a hermeneutic phenomenological approach, I encouraged them to talk about their interventions with people with aphasia, their definition of spirituality, and whether they considered facilitation of expressions of spirituality in their clients with aphasia part of their therapeutic remit. Although, of course, this represents a very small sample of therapists, nevertheless some interesting themes have begun to emerge, which I hope will contribute to further dialogue