Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2021-08-03

AUTHORS

Christine Norton, Jonathan Syred, Sally Kerry, Micol Artom, Louise Sweeney, Ailsa Hart, Wladyslawa Czuber-Dochan, Stephanie J. C. Taylor, Borislava Mihaylova, Chris Roukas, Qasim Aziz, Laura Miller, Richard Pollok, Sonia Saxena, Imogen Stagg, Helen Terry, Zohra Zenasni, Lesley Dibley, Rona Moss-Morris

ABSTRACT

BACKGROUND: Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. 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. PRIMARY RESEARCH QUESTION: 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 (0-10 scale) compared with care as usual? METHODS: 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 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation. 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 months post randomisation will be compared between the study groups. DISCUSSION: 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' 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. TRIAL REGISTRATION: ISRCTN71618461 . Registered on 9 September 2019. More... »

PAGES

516

References to SciGraph publications

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  • Journal

    TITLE

    Trials

    ISSUE

    1

    VOLUME

    22

    Author Affiliations

  • King’s College London, 57 Waterloo Road, London, SE1 8WA UK
  • Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB UK
  • NHS Digital, Skipton House, 80 London Road, London, SE1 6LH UK
  • Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
  • IBD Unit, St Mark’s Hospital, Watford Road, Harrow, HA13UJ UK
  • Institute of Population Health Sciences, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB UK
  • Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF UK
  • Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 26 Ashfield Street, London, E1 2AJ UK
  • Department of Gastroenterology, St George’s University Hospitals NHS Foundation Trust and St George’s University of London, London, SW17 0QT UK
  • Department of Primary Care and Public Health Imperial College London, London, UK
  • London North West University Hospitals, Watford Road, Harrow, HA1 3UJ UK
  • Crohn’s & Colitis UK, 1 Bishops Square (Helios Court), Hatfield Business Park, Hatfield, Hertfordshire, AL10 9NE UK
  • School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, (Avery Hill Campus), London, SE9 2UG UK
  • Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s13063-021-05466-4

    DOI

    http://dx.doi.org/10.1186/s13063-021-05466-4

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1140145100

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/34344432


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