Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT)

IntroductionFatigue remains pervasive, disabling and challenging to manage across all inflammatory rheumatic diseases (IRDs). Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable...

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Veröffentlicht in:BMJ open 2019-01, Vol.9 (1), p.e026793-e026793
Hauptverfasser: Martin, Kathryn R, Bachmair, Eva-Maria, Aucott, Lorna, Dures, Emma, Emsley, Richard, Gray, Stuart R, Hewlett, Sarah, Kumar, Vinod, Lovell, Karina, Macfarlane, Gary J, MacLennan, Graeme, McNamee, Paul, Norrie, John, Paul, Lorna, Ralston, Stuart, Siebert, Stefan, Wearden, Alison, White, Peter D, Basu, Neil
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container_issue 1
container_start_page e026793
container_title BMJ open
container_volume 9
creator Martin, Kathryn R
Bachmair, Eva-Maria
Aucott, Lorna
Dures, Emma
Emsley, Richard
Gray, Stuart R
Hewlett, Sarah
Kumar, Vinod
Lovell, Karina
Macfarlane, Gary J
MacLennan, Graeme
McNamee, Paul
Norrie, John
Paul, Lorna
Ralston, Stuart
Siebert, Stefan
Wearden, Alison
White, Peter D
Basu, Neil
description IntroductionFatigue remains pervasive, disabling and challenging to manage across all inflammatory rheumatic diseases (IRDs). Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue.Methods and analysisLIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls.Ethics approval and disseminationEthical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. A lay summary of the results will be sent to participants.Trial registration number NCT03248518; Pre-results.
doi_str_mv 10.1136/bmjopen-2018-026793
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Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue.Methods and analysisLIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls.Ethics approval and disseminationEthical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. 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Re-use permitted under CC BY. Published by BMJ.</rights><rights>2019 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. 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Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue.Methods and analysisLIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls.Ethics approval and disseminationEthical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. 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Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue.Methods and analysisLIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls.Ethics approval and disseminationEthical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. A lay summary of the results will be sent to participants.Trial registration number NCT03248518; Pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>30705244</pmid><doi>10.1136/bmjopen-2018-026793</doi><orcidid>https://orcid.org/0000-0001-7851-2039</orcidid><oa>free_for_read</oa></addata></record>
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source BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central Open Access; PubMed Central
subjects Chronic illnesses
Cognitive Behavioral Therapy - methods
Cost-Benefit Analysis
Employment
Evidence-based medicine
Exercise
Exercise Therapy - methods
Fatigue
Fatigue - therapy
Fibromyalgia
Humans
Lupus
Methods
Multicenter Studies as Topic
Multiple sclerosis
Pain
Patient satisfaction
Qualitative research
Quality of Life
Questionnaires
Randomized Controlled Trials as Topic
Rheumatic diseases
Rheumatic Fever - physiopathology
Rheumatic Fever - therapy
Rheumatoid arthritis
Rheumatology
Severity of Illness Index
title Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT)
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-06T06%3A49%3A45IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Protocol%20for%20a%20multicentre%20randomised%20controlled%20parallel-group%20trial%20to%20compare%20the%20effectiveness%20of%20remotely%20delivered%20cognitive-behavioural%20and%20graded%20exercise%20interventions%20with%20usual%20care%20alone%20to%20lessen%20the%20impact%20of%20fatigue%20in%20inflammatory%20rheumatic%20diseases%20(LIFT)&rft.jtitle=BMJ%20open&rft.au=Martin,%20Kathryn%20R&rft.date=2019-01-01&rft.volume=9&rft.issue=1&rft.spage=e026793&rft.epage=e026793&rft.pages=e026793-e026793&rft.issn=2044-6055&rft.eissn=2044-6055&rft_id=info:doi/10.1136/bmjopen-2018-026793&rft_dat=%3Cproquest_pubme%3E2173532318%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2173532318&rft_id=info:pmid/30705244&rfr_iscdi=true