A mixed-methods feasibility study of a new digital health support package for people after stroke : The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) intervention

Background Evidence for digital health programmes to support people living with stroke is growing. We assessed the feasibility of a protocol and procedures for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial. Methods We conducted a mixed-method feasibility study. Participants with acute stroke were recruited from three hospitals (Melbourne, Australia). Eligibility: Adults with stroke discharged from hospital to home within 10 days, modified Rankin Score 0–4 and prior use of Short Message System (SMS)/email. While in hospital, recruited participants contributed to structured person-centred goal setting and completed baseline surveys including self-management skills and health-related quality of life. Participants were randomised 7–14 days after discharge via REDCap® (1:1 allocation). Following randomisation, the intervention group received a 12-week programme of personalised electronic support messages (average 66 messages sent by SMS or email) aligned with their goals. The control group received six electronic administrative messages. Feasibility outcomes included the following: number of patients screened and recruited, study retainment, completion of outcome measures and acceptability of the ReCAPS intervention and trial procedures (e.g. participant satisfaction survey, clinician interviews). Protocol fidelity outcomes included number of goals developed (and quality), electronic messages delivered, stop messages received and engagement with messages. We undertook inductive thematic analysis of interview/open-text survey data and descriptive analysis of closed survey questions. Results Between November 2018 and October 2019, 312 patients were screened; 37/105 (35%) eligible patients provided consent (mean age 61 years; 32% female); 33 were randomised (17 to intervention). Overall, 29 (88%) participants completed the12-week outcome assessments with 12 (41%) completed assessments in the allocated timeframe and 16 also completing the satisfaction survey (intervention=10). Overall, trial participants felt that the study was worthwhile and most would recommend it to others. Six clinicians participated in one of three focus group interviews; while they reported that the trial and the process of goal setting were acceptable, they raised concerns regarding the additional time required to personalise goals. Conclusion The study protocol and procedures were feasible with acceptable retention of participants. Consent and goal personalisation procedures should be centralised for the phase III trial to reduce the burden on hospital clinicians. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12618001468213 (date 31/08/2018); Universal Trial Number: U1111-1206-723

Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)

Rationale: To address unmet needs, electronic messages to support person-centred goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited. Hypothesis: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomisation. Methods and design: Multicentre, double-blind, randomised controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalised, goal-centred and administrative electronic messages, while the control group only receives administrative messages. The trial includes a process evaluation, assessment of treatment fidelity and an economic evaluation. Participants: Confirmed stroke (modified Rankin Score: 0-4), aged �18 years with internet/mobile phone access, discharged directly home from hospital. Randomisation: 1:1 computer-generated, stratified by age and baseline disability. Outcomes Assessments: Collected at 90 days and 12 months following randomisation. Outcomes: Primary: Hospital emergency presentations/admissions within 90 days of randomisation. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months. Sample size: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of α=0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n=668 are obtained, with maximum sample capped at 1100. Discussion: We will provide new evidence on the potential effectiveness, implementation and cost-effectiveness of a tailored eHealth intervention for survivors of stroke

Treatment with exenatide in acute ischaemic stroke trial protocol: A prospective, randomised, open label, blinded end-point study of exenatide vs. standard care in post stroke hyperglycaemia

Rationale Post-stroke hyperglycemia occurs in up to 50% of patients presenting with acute ischemic stroke. It reduces the efficacy of thrombolysis, increases infarct size, and worsens clinical outcomes. Insulin-based therapies have generally not been beneficial in treating post-stroke hyperglycemia as they are difficult to implement, may cause hypoglycaemia, possibly increase mortality and worsen clinical outcomes. Exenatide may be a safer, simpler, and more effective alternative to insulin in acute ischemic stroke. Design TEXAIS is a three year, Phase 2, multi-center, prospective, randomized, open label, blinded end-point trial comparing exenatide to standard of care. It aims to recruit 528 patients with a primary end point of major neurological improvement at 7 days defined as a ≥8-point improvement in NIHSS score, or NIHSS 0–1. Secondary outcomes of hyper- and hypoglycaemia at 5 days and NIHSS and mRS at 90 days will be measured. The treatment arm will receive exenatide 5 µg subcutaneously twice daily. The control arm will receive standard stroke unit care. Continuous glucose monitors will track the dynamic variability of glucose. Conclusion TEXAIS aims to show that exenatide is safe and effective in the treatment of post-stroke hyperglycemia. It has been designed to be highly generalizable with an ability to enroll a large percentage of patients with acute ischemic stroke, regardless of admission blood glucose level, diabetes status, or stroke severity, with very low risk of hypoglycemia. Trial registration: ClinicalTrials.gov/ANZCTR NTA112

Outcomes for patients with in-hospital stroke: a multicenter study from the Australian Stroke Clinical Registry (AuSCR)

Background: The quality of care and outcomes for people who experience stroke whilst in hospital for another condition has not been previously studied in Australia. Aims: To explore differences in long-term outcomes among patients with in-hospital events treated in stroke units (SUs) compared to those managed in other hospital wards. Methods: Forty-five hospitals participating in the Australian Stroke Clinical Registry between January 2010 and December 2014 contributed data. Survival of all patients with in-hospital stroke to 180 days after stroke and health-related quality of life, using EQ-5D-3L among 73% eligible, were compared using multilevel, multivariable regression models. Models were adjusted for age, sex, index of relative socioeconomic disadvantage, ability to walk, stroke type, transfer from another hospital, and history of stroke. Results: Among 20,786 stroke events, 1182 (5.1%) occurred in-hospital (median age 77 years, 49% male). Patients with in-hospital stroke treated in SUs died less often within 30 days (Hazard Ratio 0.56; 95% CI 0.39-0.81) than those not admitted to SUs. Survivors reported similar health-related quality of life between 90 and 180 days compared to those treated in other wards (coefficient = 0.01, 95% CI –0.06-0.09, P =.78). Patients managed in SUs more often received recommended management (e.g. swallowing screening). Conclusion: The benefits of SU care may extend to patients experiencing in-hospital stroke. Validation, including accounting for potential residual confounding factors, is required

Quality of life is poorer for patients with stroke who require an interpreter : An observational Australian Registry study

Background and Purpose— In multicultural Australia, some patients with stroke cannot fully understand, or speak, English. Language barriers may reduce quality of care and consequent outcomes after stroke, yet little has been reported empirically. Methods— An observational study of patients with stroke or transient ischemic attack (2010–2015) captured from 45 hospitals participating in the Australian Stroke Clinical Registry. The use of interpreters in hospitals, which is routinely documented, was used as a proxy for severe language barriers. Health-Related Quality of Life was assessed using the EuroQoL-5 dimension-3 level measured 90 to 180 days after stroke. Logistic regression was undertaken to assess the association between domains of EuroQoL-5 dimension and interpreter status. Results— Among 34 562 registrants, 1461 (4.2%) required an interpreter. Compared with patients without interpreters, patients requiring an interpreter were more often women (53% versus 46%; P<0.001), aged ≥75 years (68% versus 51%; P<0.001), and had greater access to stroke unit care (85% versus 78%; P<0.001). After accounting for patient characteristics and stroke severity, patients requiring interpreters had comparable discharge outcomes (eg, mortality, discharged to rehabilitation) to patients not needing interpreters. However, these patients reported poorer Health-Related Quality of Life (visual analogue scale coefficient, −9; 95% CI, −12.38, −5.62), including more problems with self-care (odds ratio: 2.22; 95% CI, 1.82, 2.72), pain (odds ratio: 1.84; 95% CI, 1.52, 2.34), anxiety or depression (odds ratio: 1.60; 95% CI, 1.33, 1.93), and usual activities (odds ratio: 1.62; 95% CI, 1.32, 2.00). Conclusions— Patients requiring interpreters reported poorer Health Related Quality of Life after stroke/transient ischemic attack despite greater access to stroke units. These findings should be interpreted with caution because we are unable to account for prestroke Health Related Quality of Life. Further research is needed