Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial
Abstract Background Cognitive difficulties experienced by people with multiple sclerosis (MS) impact on quality of life and daily functioning, from childcare and work to social and self-care activities. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic,...
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| Format: | Article |
| Language: | English |
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BMC
2023-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07080-y |
| _version_ | 1797945729256259584 |
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| author | Christopher P. Dwyer Alberto Alvarez-Iglesias Robert Joyce Timothy J. Counihan Dympna Casey Sinéad M. Hynes |
| author_facet | Christopher P. Dwyer Alberto Alvarez-Iglesias Robert Joyce Timothy J. Counihan Dympna Casey Sinéad M. Hynes |
| author_sort | Christopher P. Dwyer |
| collection | DOAJ |
| description | Abstract Background Cognitive difficulties experienced by people with multiple sclerosis (MS) impact on quality of life and daily functioning, from childcare and work to social and self-care activities. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic, individualised cognitive rehabilitation intervention to address the wide-ranging symptoms and functional difficulties that present in MS, including the ability to maintain employment, social activities, home management and self-care. The aim of the research is to evaluate the feasibility and preliminary efficacy of COB-MS for people with MS. Methods Due to the impacts of COVID-19, trial activities that were planned for in-person delivery were completed remotely. One hundred and twenty people with MS will be assigned to participate in either the COB-MS programme or a treatment-as-usual, wait-list control group as part of this single-blind, cluster-randomised controlled feasibility and preliminary efficacy trial of the COB-MS programme. The COB-MS group will participate in an eight-session occupational-based cognitive rehabilitation programme over 9 weeks. The COB-MS intervention was planned for in-person delivery but was delivered online by occupational therapists to small groups of people with MS. The primary outcome measure is the Goal Attainment Scaling at 12 weeks. Participants will be assessed pre-intervention, post-intervention, 12 weeks post-intervention and 6 months post-intervention. Qualitative evaluations of participants’ perspectives will also be examined as part of the feasibility study. Data, due to be collected in-person, was collected online or by post. The original study design, including the statistical analysis plan, remains unchanged despite the shift to a remote trial conduct. Discussion Results will provide recommendations for a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy. Trial registration ISRCTN ISRCTN11462710 . Registered on 9 September 2019 and updated on 23 September 2020 to account for changes outlined here. |
| first_indexed | 2024-04-10T20:59:43Z |
| format | Article |
| id | doaj.art-3f94d3f250554577856281e03f05f1dd |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-10T20:59:43Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-3f94d3f250554577856281e03f05f1dd2023-01-22T12:24:17ZengBMCTrials1745-62152023-01-012411410.1186/s13063-023-07080-yEvaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trialChristopher P. Dwyer0Alberto Alvarez-Iglesias1Robert Joyce2Timothy J. Counihan3Dympna Casey4Sinéad M. Hynes5Discipline of Occupational Therapy, School of Health Sciences, National University of Ireland GalwayHealth Research Board Clinical Research Facility, National University of Ireland GalwayDiscipline of Occupational Therapy, School of Health Sciences, National University of Ireland GalwayDepartment of Neurology, University Hospital GalwayQualitative Research Trials Centre (QUESTS), School of Nursing & Midwifery, National University of Ireland GalwayDiscipline of Occupational Therapy, School of Health Sciences, National University of Ireland GalwayAbstract Background Cognitive difficulties experienced by people with multiple sclerosis (MS) impact on quality of life and daily functioning, from childcare and work to social and self-care activities. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic, individualised cognitive rehabilitation intervention to address the wide-ranging symptoms and functional difficulties that present in MS, including the ability to maintain employment, social activities, home management and self-care. The aim of the research is to evaluate the feasibility and preliminary efficacy of COB-MS for people with MS. Methods Due to the impacts of COVID-19, trial activities that were planned for in-person delivery were completed remotely. One hundred and twenty people with MS will be assigned to participate in either the COB-MS programme or a treatment-as-usual, wait-list control group as part of this single-blind, cluster-randomised controlled feasibility and preliminary efficacy trial of the COB-MS programme. The COB-MS group will participate in an eight-session occupational-based cognitive rehabilitation programme over 9 weeks. The COB-MS intervention was planned for in-person delivery but was delivered online by occupational therapists to small groups of people with MS. The primary outcome measure is the Goal Attainment Scaling at 12 weeks. Participants will be assessed pre-intervention, post-intervention, 12 weeks post-intervention and 6 months post-intervention. Qualitative evaluations of participants’ perspectives will also be examined as part of the feasibility study. Data, due to be collected in-person, was collected online or by post. The original study design, including the statistical analysis plan, remains unchanged despite the shift to a remote trial conduct. Discussion Results will provide recommendations for a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy. Trial registration ISRCTN ISRCTN11462710 . Registered on 9 September 2019 and updated on 23 September 2020 to account for changes outlined here.https://doi.org/10.1186/s13063-023-07080-yMultiple sclerosisOccupational therapyCognitive Occupation-Based programmeCognitive rehabilitationFeasibilityProtocol |
| spellingShingle | Christopher P. Dwyer Alberto Alvarez-Iglesias Robert Joyce Timothy J. Counihan Dympna Casey Sinéad M. Hynes Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial Trials Multiple sclerosis Occupational therapy Cognitive Occupation-Based programme Cognitive rehabilitation Feasibility Protocol |
| title | Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial |
| title_full | Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial |
| title_fullStr | Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial |
| title_full_unstemmed | Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial |
| title_short | Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial |
| title_sort | evaluating the feasibility and preliminary efficacy of a cognitive occupation based programme for people with multiple sclerosis cob ms an update to the protocol for a feasibility cluster randomised controlled trial |
| topic | Multiple sclerosis Occupational therapy Cognitive Occupation-Based programme Cognitive rehabilitation Feasibility Protocol |
| url | https://doi.org/10.1186/s13063-023-07080-y |
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