Florey Department of Neuroscience and Mental Health - Research Publications
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ItemMixed methods evaluation to explore participant experiences of a pilot randomized trial to facilitate self-management of people living with stroke: Inspiring virtual enabled resources following vascular events (iVERVE)(WILEY, 2022-10)INTRODUCTION: Despite digital health tools being popular for supporting self-management of chronic diseases, little research has been undertaken on stroke. We developed and pilot tested, using a randomized controlled design, a multicomponent digital health programme, known as Inspiring Virtual Enabled Resources following Vascular Events (iVERVE), to improve self-management after stroke. The 4-week trial incorporated facilitated person-centred goal setting, with those in the intervention group receiving electronic messages aligned to their goals, versus limited administrative messages for the control group. In this paper, we describe the participant experience of the various components involved with the iVERVE trial. METHODS: Mixed method design: satisfaction surveys (control and intervention) and a focus group interview (purposively selected intervention participants). Experiences relating to goal setting and overall trial satisfaction were obtained from intervention and control participants, with feedback on the electronic message component from intervention participants. Inductive thematic analysis was used for interview data and open-text responses, and closed questions were summarized descriptively. Triangulation of data allowed participants' perceptions to be explored in depth. RESULTS: Overall, 27/54 trial participants completed the survey (13 intervention: 52%; 14 control: 48%); and 5/8 invited participants in the intervention group attended the focus group. Goal setting: The approach was considered comprehensive, with the involvement of health professionals in the process helpful in developing realistic, meaningful and person-centred goals. Electronic messages (intervention): Messages were perceived as easy to understand (92%), and the frequency of receipt was considered appropriate (11/13 survey; 4/5 focus group). The content of messages was considered motivational (62%) and assisted participants to achieve their goals (77%). Some participants described the benefits of receiving messages as a 'reminder' to act. Overall trial satisfaction: Messages were acceptable for educating about stroke (77%). Having options for short message services or email to receive messages was considered important. Feedback on the length of the intervention related to specific goals, and benefits of receiving the programme earlier after stroke was expressed. CONCLUSION: The participant experience has indicated acceptance and utility of iVERVE. Feedback from this evaluation is invaluable to inform refinements to future Phase II and III trials, and wider research in the field. PATIENT OR PUBLIC CONTRIBUTION: Two consumer representatives sourced from the Stroke Foundation (Australia) actively contributed to the design of the iVERVE programme. In this study, participant experiences directly contributed to the further development of the iVERVE intervention and future trial design.
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ItemA 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(BMC, 2022-11-19)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: U1111-1206-7237.
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ItemScreening for Fabry Disease in Young Strokes in the Australian Stroke Clinical Registry (AuSCR)(FRONTIERS MEDIA SA, 2020-11-24)Introduction: Fabry disease (FD) is an X-linked lysosomal storage disorder characterized by a deficiency or absence of alpha-galactosidase A (α-GAL A) enzyme, where stroke can be a serious complication. The aim of this study is to determine the feasibility of centralized screening for FD, among young stroke adults registered in the national Australian Stroke Clinical Registry (AuSCR). Methods: The study was conducted in young (age 18 - 55 years) survivors of acute stroke of unknown etiology registered in AuSCR at hospitals in Queensland, Tasmania, New South Wales, and Victoria during 2014 - 2015; and who, at the 3-month outcome assessment, agreed to be re-contacted for future research. Descriptive analyses of case identification from responses and specific enzyme and DNA sequencing analyses were conducted for α-galactosidase A (α-GLA) from dried blood spot (DBS) testing. Results: Of 326 AuSCR-identified patients invited to participate, 58 (18%) provided consent but six were subsequently unable to provide a blood sample and two later withdrew consent to use their data. Among the remaining 50 participants (median age 53 years [48 - 56 years]; 47% female), 67% had experienced an acute ischemic stroke. All males (n = 27) had an initial screen for α-GLA enzyme activity of whom seven with low enzyme levels had normal secondary α-GLA gene analysis. All females (n = 23) had genetic analysis, with one shown to have a pathogenic c.352C>T p.(Arg118Cys) missense mutation of the α-GLA gene for FD. Conclusions: These findings provide logistical data for embedding a process of automated central stroke registry screening for an additional case-finding tool in FD.
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ItemPilot randomised clinical trial of an eHealth, self-management support intervention (iVERVE) for stroke: feasibility assessment in survivors 12-24 months post-event(BMC, 2020)BACKGROUND: Electronic communication is used in various populations to achieve health goals, but evidence in stroke is lacking. We pilot tested the feasibility and potential effectiveness of a novel personalised electronic self-management intervention to support person-centred goal attainment and secondary prevention after stroke. METHODS: A phase I, prospective, randomised controlled pilot trial (1:1 allocation) with assessor blinding, intention-to-treat analysis, and a process evaluation. Community-based survivors of stroke were recruited from participants in the Australian Stroke Clinical Registry (AuSCR) who had indicated their willingness to be contacted for research studies. Inclusion criteria include 1-2 years following hospital admission for stroke and living within 50 km of Monash University (Melbourne). Person-centred goals were set with facilitation by a clinician using a standardised template. The intervention group received electronic support messages aligned to their goals over 4 weeks. The control group received only 2-3 electronic administrative messages. Primary outcomes were study retention, goal attainment (assessed using Goal Attainment Scaling method) and satisfaction. Secondary outcomes were self-management (Health Education Impact Questionnaire: 8 domains), quality of life, mood and acceptability. RESULTS: Of 340 invitations sent from AuSCR, 73 responded, 68 were eligible and 57 (84%) completed the baseline assessment. At the goal-setting stage, 54/68 (79%) were randomised (median 16 months after stroke): 25 to intervention (median age 69 years; 40% female) and 29 to control (median age 68 years; 38% female). Forty-five (83%) participants completed the outcome follow-up assessment. At follow-up, goal attainment (mean GAS-T score ≥ 50) in the intervention group was achieved for goals related to function, participation and environment (control: environment only). Most intervention participants provided positive feedback and reported that the iVERVE messages were easy to understand (92%) and assisted them in achieving their goals (77%). We found preliminary evidence of non-significant improvements between the groups for most self-management domains (e.g. social integration and support: β coefficient 0.34; 95% CI - 0.14 to 0.83) and several quality-of-life domains in favour of the intervention group. CONCLUSION: These findings support the need for further randomised effectiveness trials of the iVERVE program to be tested in people with new stroke. TRIAL REGISTRATION: ANZCTR, ACTRN12618001519246 . Registered on 11 September 2018-retrospectively registered.
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ItemDevelopment of an electronic health message system to support recovery after stroke: Inspiring Virtual Enabled Resources following following Vascular Events (iVERVE)(DOVE MEDICAL PRESS LTD, 2018)PURPOSE: Worldwide, stroke is a leading cause of disease burden. Many survivors have unmet needs after discharge from hospital. Electronic communication technology to support post-discharge care has not been used for patients with stroke. In this paper, we describe the development of a novel electronic messaging system designed for survivors of stroke to support their goals of recovery and secondary prevention after hospital discharge. PARTICIPANTS AND METHODS: This was a formative evaluation study. The design was informed by a literature search, existing data from survivors of stroke, and behavior change theories. We established two working groups; one for developing the electronic infrastructure and the other (comprising researchers, clinical experts and consumer representatives) for establishing the patient-centered program. Following agreement on the categories for the goal-setting menu, we drafted relevant messages to support and educate patients. These messages were then independently reviewed by multiple topic experts. Concurrently, we established an online database to capture participant characteristics and then integrated this database with a purpose-built messaging system. We conducted alpha testing of the approach using the first 60 messages. RESULTS: The initial goal-setting menu comprised 26 subcategories. Following expert review, another 8 goal subcategories were added to the secondary prevention category: managing cholesterol; smoking; physical activity; alcohol consumption; weight management; medication management; access to health professionals, and self-care. Initially, 455 health messages were created by members of working group 2. Following refinement and mapping to different goals by the project team, 980 health messages across the health goals and 69 general motivational messages were formulated. Seventeen independent reviewers assessed the messages and suggested adding 73 messages and removing 16 (2%). Overall, 1,233 messages (18 administrative, 69 general motivation and 1,146 health-related) were created. CONCLUSION: This novel electronic self-management support system is ready to be pilot tested in a randomized controlled trial in patients with stroke.
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ItemNo Preview AvailableImproving economic evaluations in stroke: A report from the ESO Health Economics Working Group(SAGE PUBLICATIONS LTD, 2020-06)INTRODUCTION: Approaches to economic evaluations of stroke therapies are varied and inconsistently described. An objective of the European Stroke Organisation (ESO) Health Economics Working Group is to standardise and improve the economic evaluations of interventions for stroke. METHODS: The ESO Health Economics Working Group and additional experts were contacted to develop a protocol and a guidance document for data collection for economic evaluations of stroke therapies. A modified Delphi approach, including a survey and consensus processes, was used to agree on content. We also asked the participants about resources that could be shared to improve economic evaluations of interventions for stroke. RESULTS: Of 28 experts invited, 16 (57%) completed the initial survey, with representation from universities, government, and industry. More than half of the survey respondents endorsed 13 specific items to include in a standard resource use questionnaire. Preferred functional/quality of life outcome measures to use for economic evaluations were the modified Rankin Scale (14 respondents, 88%) and the EQ-5D instrument (11 respondents, 69%). Of the 12 respondents who had access to data used in economic evaluations, 10 (83%) indicated a willingness to share data. A protocol template and a guidance document for data collection were developed and are presented in this article. CONCLUSION: The protocol template and guidance document for data collection will support a more standardised and transparent approach for economic evaluations of stroke care.