Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial

Background Aphasia affects the ability to speak, comprehend spoken language, read and write. One third of stroke survivors experience aphasia. Evidence suggests that aphasia can continue to improve after the first few months with intensive speech and language therapy, which is frequently beyond what resources allow. The development of computer software for language practice provides an opportunity for self-managed therapy. This pragmatic randomised controlled trial will investigate the clinical and cost effectiveness of a computerised approach to long-term aphasia therapy post stroke. Methods/Design A total of 285 adults with aphasia at least four months post stroke will be randomly allocated to either usual care, computerised intervention in addition to usual care or attention and activity control in addition to usual care. Those in the intervention group will receive six months of self-managed word finding practice on their home computer with monthly face-to-face support from a volunteer/assistant. Those in the attention control group will receive puzzle activities, supplemented by monthly telephone calls. Study delivery will be coordinated by 20 speech and language therapy departments across the United Kingdom. Outcome measures will be made at baseline, six, nine and 12 months after randomisation by blinded speech and language therapist assessors. Primary outcomes are the change in number of words (of personal relevance) named correctly at six months and improvement in functional conversation. Primary outcomes will be analysed using a Hochberg testing procedure. Significance will be declared if differences in both word retrieval and functional conversation at six months are significant at the 5% level, or if either comparison is significant at 2.5%. A cost utility analysis will be undertaken from the NHS and personal social service perspective. Differences between costs and quality-adjusted life years in the three groups will be described and the incremental cost effectiveness ratio will be calculated. Treatment fidelity will be monitored. Discussion This is the first fully powered trial of the clinical and cost effectiveness of computerised aphasia therapy. Specific challenges in designing the protocol are considered. Trial registration Registered with Current Controlled Trials ISRCTN68798818 webcite on 18 February 2014

Motivational interviewing for low mood and adjustment early after stroke: a feasibility randomised trial

Background Management of psychological adjustment and low mood after stroke can result in positive health outcomes. We have adapted a talk-based therapy, motivational interviewing (MI), and shown it to be potentially effective for managing low mood and supporting psychological adjustment post-stroke in a single-centre trial. In the current study, we aimed to explore the feasibility of delivering MI using clinical stroke team members, and using an attention control (AC), to inform the protocol for a future definitive trial. Methods This parallel two-arm feasibility trial took place in north-west England. Recruitment occurred between December 2012 and November 2013. Participants were stroke patients aged 18 years or over, who were medically stable, had no severe communication problems, and were residents of the hospital catchment. Randomisation was to MI or AC, and was conducted by a researcher not involved in recruitment using opaque sealed envelopes. The main outcome measures were descriptions of study feasibility (recruitment/retention rates, MI delivery by clinical staff, use of AC) and acceptability (through qualitative interviews and completion of study measures), and fidelity to MI and AC (through review of session audio-recordings). Information was also collected on participants’ mood, quality of life, adjustment, and resource-use. Results Over 12 months, 461 patients were screened, 124 were screened eligible, and 49 were randomised: 23 to MI, 26 to AC. At 3 months, 13 MI and 18 AC participants completed the follow-up assessment (63% retention). This was less than expected based on our original trial. An AC was successfully implemented. Alternative approaches would be required to ensure the feasibility of clinical staff delivering MI. The study measures, MI, and AC interventions were considered acceptable, and there was good fidelity to the interventions. There were no adverse events related to study participation. Conclusions It was possible to recruit and retain participants, train clinical staff to deliver MI, and implement an appropriate AC. Changes would be necessary to conduct a future multi-centre trial, including: assuming a recruitment rate lower than that in the current study; implementing more strategies to increase participant retention; and considering alternative clinical staff groups to undertake the delivery of MI and AC

Psychometric properties of the Behavioural Outcomes of Anxiety questionnaire in stroke patients with aphasia.

OBJECTIVE: To evaluate the psychometric properties of an observational, carer-completed anxiety screen for aphasic stroke patients. DESIGN: Phase 1: A cross-sectional questionnaire design to establish psychometric properties. Phase 2: A randomized longitudinal design with treatment and control to evaluate sensitivity to change and repeatability/reliability. SUBJECTS: Phase 1: 111 patient-carer dyads were recruited through stroke charities: patient mean age 69.7(10. 7), 6.2(5. 2) years since stroke, 76 male; carer mean age 64.7(12. 2), 27 male. Phase 2. A subsample of 50 dyads (29 completed). MEASURES: All patients completed the Tension Rating Circles and the Frenchay Aphasia Screening Test. Carers completed the Behavioural Outcomes of Anxiety questionnaire, observational versions of the Hospital Anxiety and Depression Scale (HADS-A) and the Generalised Anxiety Disorder-7, and a feedback questionnaire. INTERVENTION: Phase 2: 25 dyads were offered relaxation training and 25 acted as controls. RESULTS: The Behavioural Outcomes of Anxiety questionnaire correlated .77 with the HADS-A and Cronbach's Alpha was .82 demonstrating validity and internal consistency. Using HADS-A cut-off > 7 as criterion the area under the curve was 0.90 and at cut-off of > 16 sensitivity (0.85) and specificity (0.85) were both good. Scores declined significantly more in a group given anxiety training ( n = 12) than in a control group ( n = 17), demonstrating sensitivity to change and construct validity. Two-week repeatability/reliability was .92. Feedback suggested the scale was acceptable. CONCLUSIONS: The Behavioural Outcomes of Anxiety questionnaire shows promise as an anxiety screen for stroke patients with aphasia and is sensitive to change. Further analysis of dimensionality and discriminant validity is needed

Behavioural activation therapy for depression after stroke (BEADS): a study protocol for a feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression

Background There is currently insufficient evidence for the clinical and cost-effectiveness of psychological therapies for treating post-stroke depression. Methods/Design BEADS is a parallel group feasibility multicentre randomised controlled trial with nested qualitative research and economic evaluation. The aim is to evaluate the feasibility of undertaking a full trial comparing behavioural activation (BA) to usual stroke care for 4 months for patients with post-stroke depression. We aim to recruit 72 patients with post-stroke depression over 12 months at three centres, with patients identified from the National Health Service (NHS) community and acute services and from the voluntary sector. They will be randomly allocated to receive behavioural activation in addition to usual care or usual care alone. Outcomes will be measured at 6 months after randomisation for both participants and their carers, to determine their effectiveness. The primary clinical outcome measure for the full trial will be the Patient Health Questionnaire-9 (PHQ-9). Rates of consent, recruitment and follow-up by centre and randomised group will be reported. The acceptability of the intervention to patients, their carers and therapists will also be assessed using qualitative interviews. The economic evaluation will be undertaken from the National Health Service and personal social service perspective, with a supplementary analysis from the societal perspective. A value of information analysis will be completed to identify the areas in which future research will be most valuable. Discussion The feasibility outcomes from this trial will provide the data needed to inform the design of a definitive multicentre randomised controlled trial evaluating the clinical and cost-effectiveness of behavioural activation for treating post-stroke depression

The Stroke Outcomes Study 2 (SOS2): a prospective, analytic cohort study of depressive symptoms after stroke

<p>Abstract</p> <p>Background</p> <p>Mood disorder is recognised as an important and common problem after stroke but little is known about the longer term effects of mood on functional outcomes. This protocol paper describes the Stroke Outcomes Study 2 (SOS2), a research study conducted in two large acute NHS Trusts in the North of England, which was designed to investigate the impact of early depressive symptoms on outcomes after an acute stroke.</p> <p>Methods and design</p> <p>SOS2 was a prospective cohort study that aimed to recruit patients in the first few weeks after a stroke, and to follow them up at regular intervals for one year thereafter in order to describe the trajectory of psychological symptoms and study their impact on physical functional recovery. Measures of mood and function were completed at baseline (approximately 3 weeks) and at four follow-up time-points: approximately 9, 13, 26 and 52 weeks after the index stroke.</p> <p>Discussion</p> <p>Recruiting patients to research studies soon after an acute stroke is difficult. Mortality following stroke is approximately 30% and in the region of half the patients that survive the initial event are significantly disabled. Together these factors reduced the number of patients available to participate in SOS2 but once recruited to the study the drop-out rate was relatively low. During the recruitment period over 6000 admissions for stroke or query stroke were screened for eligibility. A cohort of 592 study participants was finally achieved.</p

Assessing organisational readiness for change:Use of diagnostic analysis prior to the implementation of a multidisciplinary assessment for acute stroke care

BACKGROUND: Achieving evidence-based practice in health care is integral to the drive for quality improvement in the National Health Service in the UK. Encapsulated within this policy agenda are challenges inherent in leading and managing organisational change. Not least of these is the need to change the behaviours of individuals and groups in order to embed new practices. Such changes are set within a context of organisational culture that can present a number of barriers and facilitators to change. Diagnostic analysis has been recommended as a precursor to the implementation of change to enable such barriers and facilitators to be identified and a targeted implementation strategy developed. Although diagnostic analysis is recommended, there is a paucity of advice on appropriate methods to use. This paper addresses the paucity and builds on previous work by recommending a mixed method approach to diagnostic analysis comprising both quantitative and qualitative data. METHODS: Twenty staff members with strategic accountability for stroke care were purposively sampled to take part in semi-structured interviews. Six recently discharged patients were also interviewed. Focus groups were conducted with one group of registered ward-based nurses (n = 5) and three specialist registrars (n = 3) purposively selected for their interest in stroke care. All professional staff on the study wards were sent the Team Climate Inventory questionnaire (n = 206). This elicited a response rate of 72% (n = 148). RESULTS: A number of facilitators for change were identified, including stakeholder support, organisational commitment to education, strong team climate in some teams, exemplars of past successful organisational change, and positive working environments. A number of barriers were also identified, including: unidisciplinary assessment/recording practices, varying in structure and evidence-base; weak team climate in some teams; negative exemplars of organisational change; and uncertainty created by impending organisational merger. CONCLUSION: This study built on previous research by proposing a mixed method approach for diagnostic analysis. The combination of qualitative and quantitative data were able to capture multiple perspectives on barriers and facilitators to change. These data informed the tailoring of the implementation strategy to the specific needs of the Trust

Stroke patients' utilisation of extrinsic feedback from computer-based technology in the home: a multiple case study realistic evaluation

Background Evidence indicates that post − stroke rehabilitation improves function, independence and quality of life. A key aspect of rehabilitation is the provision of appropriate information and feedback to the learner. Advances in information and communications technology (ICT) have allowed for the development of various systems to complement stroke rehabilitation that could be used in the home setting. These systems may increase the provision of rehabilitation a stroke survivor receives and carries out, as well as providing a learning platform that facilitates long-term self-managed rehabilitation and behaviour change. This paper describes the application of an innovative evaluative methodology to explore the utilisation of feedback for post-stroke upper-limb rehabilitation in the home. Methods Using the principles of realistic evaluation, this study aimed to test and refine intervention theories by exploring the complex interactions of contexts, mechanisms and outcomes that arise from technology deployment in the home. Methods included focus groups followed by multi-method case studies (n = 5) before, during and after the use of computer-based equipment. Data were analysed in relation to the context-mechanism-outcome hypotheses case by case. This was followed by a synthesis of the findings to answer the question, ‘what works for whom and in what circumstances and respects?’ Results Data analysis reveals that to achieve desired outcomes through the use of ICT, key elements of computer feedback, such as accuracy, measurability, rewarding feedback, adaptability, and knowledge of results feedback, are required to trigger the theory-driven mechanisms underpinning the intervention. In addition, the pre-existing context and the personal and environmental contexts, such as previous experience of service delivery, personal goals, trust in the technology, and social circumstances may also enable or constrain the underpinning theory-driven mechanisms. Conclusions Findings suggest that the theory-driven mechanisms underpinning the utilisation of feedback from computer-based technology for home-based upper-limb post-stroke rehabilitation are dependent on key elements of computer feedback and the personal and environmental context. The identification of these elements may therefore inform the development of technology; therapy education and the subsequent adoption of technology and a self-management paradigm; long-term self-managed rehabilitation; and importantly, improvements in the physical and psychosocial aspects of recovery

Speech, language, and communication in a public health context: A UK perspective with potential global application-An opinion piece

Speech and language therapists often contribute to public awareness campaigns as well as supporting, teaching and promoting the facilitation of speech, language, communication, and safe swallowing with the general public and health and social care professionals. These are sometimes considered as public health interventions. It is important to consider the objectives, costs, and impact of this involvement in the same way as reviewing the evidence associated with the more personally targeted interventions with individuals or groups of clients with specific conditions. This opinion piece discusses speech and language therapy in the context of public health, clarifies the terminology, and proposes different approaches to demonstrate its influence associated with its objectives. The content has been informed by a Working Party of the Royal College of Speech and Language Therapists (2017–2018).No Full Tex