PMID- 30705244 OWN - NLM STAT- MEDLINE DCOM- 20200219 LR - 20210109 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 9 IP - 1 DP - 2019 Jan 30 TI - 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). PG - e026793 LID - 10.1136/bmjopen-2018-026793 [doi] LID - e026793 AB - INTRODUCTION: Fatigue 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 ANALYSIS: LIFT 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 DISSEMINATION: Ethical 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. CI - (c) Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. FAU - Martin, Kathryn R AU - Martin KR AD - Epidemiology Group, University of Aberdeen, Aberdeen, UK. AD - Aberdeen Centre for Arthritis and Musculoskeletal Health, University of Aberdeen, Aberdeen, UK. FAU - Bachmair, Eva-Maria AU - Bachmair EM AD - Epidemiology Group, University of Aberdeen, Aberdeen, UK. AD - Aberdeen Centre for Arthritis and Musculoskeletal Health, University of Aberdeen, Aberdeen, UK. FAU - Aucott, Lorna AU - Aucott L AD - Centre of Healthcare and Randomised Trials (CHaRT), Health Service Research Unit, University of Aberdeen, Aberdeen, UK. FAU - Dures, Emma AU - Dures E AD - Department of Nursing and Midwifery, University of the West of England, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK. FAU - Emsley, Richard AU - Emsley R AD - Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Gray, Stuart R AU - Gray SR AD - Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. FAU - Hewlett, Sarah AU - Hewlett S AUID- ORCID: 0000-0001-7851-2039 AD - Department of Nursing and Midwifery, University of the West of England, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK. FAU - Kumar, Vinod AU - Kumar V AD - Department of Rheumatology, Ninewells Hospital, NHS Tayside, Dundee, UK. FAU - Lovell, Karina AU - Lovell K AD - School of Health Sciences, University of Manchester, Manchester, UK. FAU - Macfarlane, Gary J AU - Macfarlane GJ AD - Epidemiology Group, University of Aberdeen, Aberdeen, UK. AD - Aberdeen Centre for Arthritis and Musculoskeletal Health, University of Aberdeen, Aberdeen, UK. FAU - MacLennan, Graeme AU - MacLennan G AD - Centre of Healthcare and Randomised Trials (CHaRT), Health Service Research Unit, University of Aberdeen, Aberdeen, UK. FAU - McNamee, Paul AU - McNamee P AD - Health Economics Research Unit, University of Aberdeen, Aberdeen, UK. FAU - Norrie, John AU - Norrie J AD - Edinburgh Clinical Trials Unit, University of Edinburgh, Western General Hospital, Edinburgh, UK. FAU - Paul, Lorna AU - Paul L AD - School of Health and Life Science, Glasgow Caledonian University, Glasgow, UK. FAU - Ralston, Stuart AU - Ralston S AD - Rheumatology and Bone Disease, University of Edinburgh, Western General Hospital, Edinburgh, UK. FAU - Siebert, Stefan AU - Siebert S AD - Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK. FAU - Wearden, Alison AU - Wearden A AD - School of Health Sciences, University of Manchester, Manchester, UK. FAU - White, Peter D AU - White PD AD - Department of Psychological Medicine, Queen Mary University of London, Bartholomew's Hospital, London, UK. FAU - Basu, Neil AU - Basu N AD - Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK. LA - eng SI - ClinicalTrials.gov/NCT03248518 GR - HERU1/CSO_/Chief Scientist Office/United Kingdom GR - HSRU1/CSO_/Chief Scientist Office/United Kingdom GR - 21175/VAC_/Versus Arthritis/United Kingdom PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190130 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Cognitive Behavioral Therapy/*methods MH - Cost-Benefit Analysis MH - Exercise Therapy/*methods MH - Fatigue/*therapy MH - Humans MH - Multicenter Studies as Topic MH - Quality of Life MH - Randomized Controlled Trials as Topic MH - Rheumatic Fever/physiopathology/*therapy MH - Severity of Illness Index PMC - PMC6359876 OTO - NOTNLM OT - cognitive behavioural OT - exercise OT - fatigue OT - inflammatory rheumatic disease OT - lift OT - randomised controlled trial COIS- Competing interests: None declared. EDAT- 2019/02/02 06:00 MHDA- 2020/02/20 06:00 PMCR- 2019/01/30 CRDT- 2019/02/02 06:00 PHST- 2019/02/02 06:00 [entrez] PHST- 2019/02/02 06:00 [pubmed] PHST- 2020/02/20 06:00 [medline] PHST- 2019/01/30 00:00 [pmc-release] AID - bmjopen-2018-026793 [pii] AID - 10.1136/bmjopen-2018-026793 [doi] PST - epublish SO - BMJ Open. 2019 Jan 30;9(1):e026793. doi: 10.1136/bmjopen-2018-026793.