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      • Record: found
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      Is Open Access

      A Tailored Occupational Therapist–Led Vocational Intervention for People With Stroke: Protocol for a Pilot Randomized Controlled Trial

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          Abstract

          Background

          Resuming work after stroke is a common goal of working-age adults, yet there are few vocational rehabilitation programs designed to address the unique challenges faced following stroke. The Work intervention was developed to address these gaps.

          Objective

          This paper presents a protocol that outlines the steps that will be undertaken to pilot both the intervention and trial processes for the Work trial.

          Methods

          The Work trial is a 2-arm, prospective, randomized, blinded-assessor study with intention-to-treat analysis. A total of 54 adults of working age who have experienced a stroke <4 months prior will be randomized 1:1 to either (1) an experimental group who will receive a 12-week early vocational intervention (Work intervention) plus usual clinical rehabilitation or (2) a control group who will receive only their usual clinical rehabilitation.

          Results

          Outcomes include study and intervention feasibility and intervention benefit. In addition to evaluating the feasibility of delivering vocational intervention early after stroke, benefit will be assessed by measuring rates of vocational participation and quality-of-life improvements at the 3- and 6-month follow-ups. Process evaluation using data collected during the study, as well as postintervention individual interviews with participants and surveys with trial therapists, will complement quantitative data.

          Conclusions

          The results of the trial will provide details on the feasibility of delivering the Work intervention embedded within the clinical rehabilitation context and inform future trial processes. Pilot data will enable a future definitive trial to determine the clinical effectiveness of vocational rehabilitation when delivered in the early subacute phase of stroke recovery.

          Trial Registration

          Australian New Zealand Clinical Trials Registry ACTRN12619001164189; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378112&isReview=true

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/40548

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          Most cited references25

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          The hospital anxiety and depression scale.

          A S Zigmond, R P Snaith (1983)
          A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The anxiety and depressive subscales are also valid measures of severity of the emotional disorder. It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments.
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            Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

            M. Herdman, C. Gudex, S Lloyd … (2011)
            Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.
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              Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis.

              Jamie Banks, Charles A. Marotta (2007)
              The modified Rankin scale (mRS), a clinician-reported measure of global disability, is widely applied for evaluating stroke patient outcomes and as an end point in randomized clinical trials. Extensive evidence on the validity of the mRS exists across a large but fragmented literature. As new treatments for acute ischemic stroke are submitted for agency approval, an appreciation of the mRS's attributes, specifically its relationship to other stroke evaluation scales, would be valuable for decision-makers to properly assess the impact of a new drug on treatment paradigms. The purpose of this report is to assemble and systematically assess the properties of the mRS to provide decision-makers with pertinent evaluative information. A Medline search was conducted to identify reports in the peer-reviewed medical literature (1957-2006) that provide information on the structure, validation, scoring, and psychometric properties of the mRS and its use in clinical trials. The selection of articles was based on defined criteria that included relevance, study design and use of appropriate statistical methods. Of 224 articles identified by the literature search, 50 were selected for detailed assessment. Inter-rater reliability with the mRS is moderate and improves with structured interviews (kappa 0.56 versus 0.78); strong test-re-test reliability (kappa=0.81 to 0.95) has been reported. Numerous studies demonstrate the construct validity of the mRS by its relationships to physiological indicators such as stroke type, lesion size, perfusion and neurological impairment. Convergent validity between the mRS and other disability scales is well documented. Patient comorbidities and socioeconomic factors should be considered in properly applying and interpreting the mRS. Recent analyses suggest that randomized clinical trials of acute stroke treatments may require a smaller sample size if the mRS is used as a primary end point rather than the Barthel Index. Multiple types of evidence attest to the validity and reliability of the mRS. The reported data support the view that the mRS is a valuable instrument for assessing the impact of new stroke treatments.
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                Author and article information

                Contributors
                Natasha A Lannin:
                ORCID: https://orcid.org/0000-0002-2066-8345
                Department of NeuroscienceMonash UniversityThe Alfred Centre, Level 699 Commercial RoadMelbourne, 3004Australia61 41 7135 153natasha.lannin@monash.edu
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: October 2022
                Publication date (Electronic): 31 October 2022
                Volume: 11
                Issue: 10
                Electronic Location Identifier: e40548
                Affiliations
                [1 ] School of Allied Health, Human Services and Sport La Trobe University Melbourne Australia
                [2 ] Department of Occupational Therapy Monash University Frankston Australia
                [3 ] Nottingham University Nottingham United Kingdom
                [4 ] Institute of Clinical Trials Research University of Leeds Leeds United Kingdom
                [5 ] Centre for Ergonomics and Human Factors School of Psychology and Public Health La Trobe University Bundoora Australia
                [6 ] Department of Occupational Therapy Alfred Health Prahran Australia
                [7 ] Department of Neuroscience Monash University Melbourne Australia
                [8 ] Department of Neurology Alfred Health Prahran Australia
                [9 ] Living with Disability Research Centre School of Allied Health La Trobe University Bundoora Australia
                [10 ] School of Medical and Health Science Edith Cowan University Joondalup Australia
                [11 ] Alfred Health Prahran Australia
                Author notes
                Corresponding Author: Natasha A Lannin natasha.lannin@ 123456monash.edu
                Author information
                https://orcid.org/0000-0001-7313-9909
                https://orcid.org/0000-0001-6246-3180
                https://orcid.org/0000-0002-2876-0584
                https://orcid.org/0000-0002-0484-8442
                https://orcid.org/0000-0002-3457-4438
                https://orcid.org/0000-0002-8365-6907
                https://orcid.org/0000-0003-0940-6624
                https://orcid.org/0000-0002-7958-5181
                https://orcid.org/0000-0002-2066-8345
                Article
                Publisher ID: v11i10e40548
                DOI: 10.2196/40548
                PMC ID: 9664318
                PubMed ID: 36315220
                SO-VID: fb528621-177e-4e0a-aca6-9d4c9e7a2695
                Copyright © ©Sophie O'Keefe, Kathryn Radford, Amanda Farrin, Jodi Oakman, Serena Alves-Stein, Geoffrey Cloud, Jacinta Douglas, Mandy Stanley, Natasha A Lannin. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 31.10.2022.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 27 June 2022
                Date revision requested : 8 July 2022
                Date revision received : 14 August 2022
                Date accepted : 18 August 2022
                Categories
                Subject: Protocol
                Subject: Protocol
                Custom metadata
                ext-peer-rev This paper was peer reviewed by the Stroke Foundation (Melbourne, Australia).

                Keywords: return to work,vocational rehabilitation,acquired brain injury,stroke,traumatic brain injury,neuroscience,rehabilitation,intervention,feasibility,stroke recovery,resume work
                Data availability:
                Keywords: return to work, vocational rehabilitation, acquired brain injury, stroke, traumatic brain injury, neuroscience, rehabilitation, intervention, feasibility, stroke recovery, resume work

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