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We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary research question<\/jats:title>\n                    <jats:p>In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency\/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0\u201310 scale) compared with care as usual?<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A pragmatic two-arm, parallel group randomised controlled trial (RCT), of a 12-session facilitator-supported online cognitive behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain and faecal urgency\/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6\u2009months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12\u2009months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation.<\/jats:p>\n                    <jats:p>We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12\u2009months post randomisation will be compared between the study groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients\u2019 quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ISRCTN71618461. Registered on 9 September 2019.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05466-4","type":"journal-article","created":{"date-parts":[[2021,8,3]],"date-time":"2021-08-03T06:02:58Z","timestamp":1627970578000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency\/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2259-0948","authenticated-orcid":false,"given":"Christine","family":"Norton","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Syred","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sally","family":"Kerry","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Micol","family":"Artom","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Sweeney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ailsa","family":"Hart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9889-1248","authenticated-orcid":false,"given":"Wladyslawa","family":"Czuber-Dochan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie J. 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IRAS (UK Ethics) number: 258725 (Additional file\n                      \n                      ). Consent is covered above.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"CN has received speaker fees from Ferring, AbbVie, Takeda and Tillotts.Jonathan Syred: none.Sally Kerry: noneMicol Artom: noneLouise Sweeney: noneAilsa Hart has served as consultant, advisory board member or speaker for AbbVie, Atlantic, Bristol-Myers Squibb, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire and Takeda. She also serves on the Global Steering Committee for Genentech.WCD has received speaker fees from Dr Falk Pharma,Stephanie Taylor: noneBorislava Mihaylova: noneChris Roukas: noneQA is a member of an advisory board for Allergan, Grunenthal and Pantheryx. Conference support\/sponsorship from Allergan, Grunenthal and Alimentary Health. Site for a phase III study with Allergan.Laura Miller: noneRichard Pollok has served as consultant, advisory board member, speaker and\/or received educational grants from Dr Falk, Pharmacosmos, Takeda, Janssen, Napp pharmaceuticals and Ferring pharmaceuticals.SS: noneImogen Stagg: noneHelen Terry: noneZZ: noneLD has received speaker fees from Janssen, AbbVie and Eli-Lilley, and consultancy fees from GL Assessments and Crohn\u2019s & Colitis UKRona Moss-Morris received personal fees from training in CBT for irritable bowel syndrome (IBS) for Central and North West London NHS Foundation Trust and University of East Anglia, outside the submitted work. She receives payment for consultancy to Mahana Therapeutics and is one of the beneficiaries of a licence agreement with King\u2019s College London and a private company for a web-based CBT product for IBS.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"516"}}