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A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol
BACKGROUND: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The majority of approaches for managing MS fatigue typically require participation in a structured, time-limited program with a fixed sequence of topics and activities. MS INFoRm (Multiple Sclerosis:...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593578/ https://www.ncbi.nlm.nih.gov/pubmed/31238966 http://dx.doi.org/10.1186/s12883-019-1367-6 |
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author | Finlayson, Marcia Akbar, Nadine Turpin, Karen Smyth, Penny |
author_facet | Finlayson, Marcia Akbar, Nadine Turpin, Karen Smyth, Penny |
author_sort | Finlayson, Marcia |
collection | PubMed |
description | BACKGROUND: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The majority of approaches for managing MS fatigue typically require participation in a structured, time-limited program with a fixed sequence of topics and activities. MS INFoRm (Multiple Sclerosis: An Interactive Fatigue Management Resource) is a self-directed MS fatigue management resource incorporating principles of self-management and adult learning. Positive results from a feasibility pilot study of a USB-delivered version of MS INFoRm led to the current trial and adaptation of MS INFoRm to a website format. The specific aims of the proposed study are to (a) to determine the effectiveness and efficacy of 3-month use of MS INFoRm on fatigue impact (primary outcome) among persons with MS, (b) to determine whether 3-month use of MS INFoRm results in improvement in secondary outcomes of self- efficacy for managing MS fatigue, self-reported cognitive function, participation and autonomy, and depression, and (c) to determine whether any improvements in primary and secondary outcomes are maintained among the MS INFoRm users after 6-months. METHODS/DESIGN: Parallel group, two arm, double-blinded superiority trial with a 1:1 allocation. Two hundred persons with MS will be randomly assigned to either an intervention (MS INFoRm) or usual care control group in which they will be given 3-month access to either the MS INFoRm website (intervention group) or a control webpage containing widely available resources on MS fatigue (control group). Baseline, immediate post-intervention (3-months), and follow-up (6-months post intervention) evaluations will take place on primary (Modified Fatigue Impact Scale) and secondary (Multiple Sclerosis Self-Efficacy Scale, Perceived Deficits Questionnaire, Center for Epidemiologic Studies Depression Scale, and Impact on Participation and Autonomy Questionnaire) measures. Hypothesis testing will involve independent samples t-tests and mixed effects ANOVAs. DISCUSSION: People with MS may benefit from easily accessible and self-directed fatigue management resources based on self-management and adult learning principles. The proposed study will provide crucial evidence about the potential of MS INFoRm as a self-management tool that can be made widely available to persons with MS as a means to effectively reduce the daily impact of MS fatigue. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03362541. Posting date December 5, 2017. |
format | Online Article Text |
id | pubmed-6593578 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-65935782019-07-09 A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol Finlayson, Marcia Akbar, Nadine Turpin, Karen Smyth, Penny BMC Neurol Study Protocol BACKGROUND: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The majority of approaches for managing MS fatigue typically require participation in a structured, time-limited program with a fixed sequence of topics and activities. MS INFoRm (Multiple Sclerosis: An Interactive Fatigue Management Resource) is a self-directed MS fatigue management resource incorporating principles of self-management and adult learning. Positive results from a feasibility pilot study of a USB-delivered version of MS INFoRm led to the current trial and adaptation of MS INFoRm to a website format. The specific aims of the proposed study are to (a) to determine the effectiveness and efficacy of 3-month use of MS INFoRm on fatigue impact (primary outcome) among persons with MS, (b) to determine whether 3-month use of MS INFoRm results in improvement in secondary outcomes of self- efficacy for managing MS fatigue, self-reported cognitive function, participation and autonomy, and depression, and (c) to determine whether any improvements in primary and secondary outcomes are maintained among the MS INFoRm users after 6-months. METHODS/DESIGN: Parallel group, two arm, double-blinded superiority trial with a 1:1 allocation. Two hundred persons with MS will be randomly assigned to either an intervention (MS INFoRm) or usual care control group in which they will be given 3-month access to either the MS INFoRm website (intervention group) or a control webpage containing widely available resources on MS fatigue (control group). Baseline, immediate post-intervention (3-months), and follow-up (6-months post intervention) evaluations will take place on primary (Modified Fatigue Impact Scale) and secondary (Multiple Sclerosis Self-Efficacy Scale, Perceived Deficits Questionnaire, Center for Epidemiologic Studies Depression Scale, and Impact on Participation and Autonomy Questionnaire) measures. Hypothesis testing will involve independent samples t-tests and mixed effects ANOVAs. DISCUSSION: People with MS may benefit from easily accessible and self-directed fatigue management resources based on self-management and adult learning principles. The proposed study will provide crucial evidence about the potential of MS INFoRm as a self-management tool that can be made widely available to persons with MS as a means to effectively reduce the daily impact of MS fatigue. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03362541. Posting date December 5, 2017. BioMed Central 2019-06-25 /pmc/articles/PMC6593578/ /pubmed/31238966 http://dx.doi.org/10.1186/s12883-019-1367-6 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Finlayson, Marcia Akbar, Nadine Turpin, Karen Smyth, Penny A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol |
title | A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol |
title_full | A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol |
title_fullStr | A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol |
title_full_unstemmed | A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol |
title_short | A multi-site, randomized controlled trial of MS INFoRm, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol |
title_sort | multi-site, randomized controlled trial of ms inform, a fatigue self-management website for persons with multiple sclerosis: rationale and study protocol |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593578/ https://www.ncbi.nlm.nih.gov/pubmed/31238966 http://dx.doi.org/10.1186/s12883-019-1367-6 |
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