. 2021 Aug 3;22(1):516.

doi: 10.1186/s13063-021-05466-4.

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

Christine Norton¹, Jonathan Syred², Sally Kerry³, Micol Artom⁴, Louise Sweeney⁵, Ailsa Hart⁶, Wladyslawa Czuber-Dochan², Stephanie J C Taylor⁷, Borislava Mihaylova^{7

8}, Chris Roukas⁷, Qasim Aziz⁹, Laura Miller³, Richard Pollok¹⁰, Sonia Saxena¹¹, Imogen Stagg¹², Helen Terry¹³, Zohra Zenasni³, Lesley Dibley¹⁴, Rona Moss-Morris¹⁵

Affiliations

¹ King's College London, 57 Waterloo Road, London, SE1 8WA, UK. Christine.norton@kcl.ac.uk.
² King's College London, 57 Waterloo Road, London, SE1 8WA, UK.
³ Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
⁴ NHS Digital, Skipton House, 80 London Road, London, SE1 6LH, UK.
⁵ Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
⁶ IBD Unit, St Mark's Hospital, Watford Road, Harrow, HA13UJ, UK.
⁷ Institute of Population Health Sciences, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
⁸ Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK.
⁹ 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.
¹⁰ Department of Gastroenterology, St George's University Hospitals NHS Foundation Trust and St George's University of London, London, SW17 0QT, UK.
¹¹ Department of Primary Care and Public Health Imperial College London, London, UK.
¹² London North West University Hospitals, Watford Road, Harrow, HA1 3UJ, UK.
¹³ Crohn's & Colitis UK, 1 Bishops Square (Helios Court), Hatfield Business Park, Hatfield, Hertfordshire, AL10 9NE, UK.
¹⁴ School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, (Avery Hill Campus), London, SE9 2UG, UK.
¹⁵ Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

PMID: 34344432
PMCID: PMC8329619
DOI: 10.1186/s13063-021-05466-4

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

Christine Norton et al. Trials. 2021.

. 2021 Aug 3;22(1):516.

doi: 10.1186/s13063-021-05466-4.

Authors

Affiliations

¹ King's College London, 57 Waterloo Road, London, SE1 8WA, UK. Christine.norton@kcl.ac.uk.
² King's College London, 57 Waterloo Road, London, SE1 8WA, UK.
³ Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
⁴ NHS Digital, Skipton House, 80 London Road, London, SE1 6LH, UK.
⁵ Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
⁶ IBD Unit, St Mark's Hospital, Watford Road, Harrow, HA13UJ, UK.
⁷ Institute of Population Health Sciences, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
⁸ Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK.
⁹ 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.
¹⁰ Department of Gastroenterology, St George's University Hospitals NHS Foundation Trust and St George's University of London, London, SW17 0QT, UK.
¹¹ Department of Primary Care and Public Health Imperial College London, London, UK.
¹² London North West University Hospitals, Watford Road, Harrow, HA1 3UJ, UK.
¹³ Crohn's & Colitis UK, 1 Bishops Square (Helios Court), Hatfield Business Park, Hatfield, Hertfordshire, AL10 9NE, UK.
¹⁴ School of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, (Avery Hill Campus), London, SE9 2UG, UK.
¹⁵ Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

PMID: 34344432
PMCID: PMC8329619
DOI: 10.1186/s13063-021-05466-4

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.

Keywords: Crohn’s disease; Faecal incontinence; Fatigue; Inflammatory bowel disease; Online self-management; Pain; RCT; Ulcerative colitis.

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Conflict of interest statement

CN has received speaker fees from Ferring, AbbVie, Takeda and Tillotts.

Jonathan Syred: none.

Sally Kerry: none

Micol Artom: none

Louise Sweeney: none

Ailsa 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: none

Borislava Mihaylova: none

Chris Roukas: none

QA 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: none

Richard 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: none

Imogen Stagg: none

Helen Terry: none

ZZ: none

LD has received speaker fees from Janssen, AbbVie and Eli-Lilley, and consultancy fees from GL Assessments and Crohn’s & Colitis UK

Rona 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’s College London and a private company for a web-based CBT product for IBS.

Figures

**Fig. 1**
Consort diagram for a randomised control trial of supported self-management for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease

See this image and copyright information in PMC

References

1. Wilson BS, Lonnfors S, Vermeire S, Greco M, Hommes DW, Bell C, et al. The true impact of IBD: a European Crohn’s and Ulcerative Colitis patient life impact survey 2010-11. 2012.
1. Czuber-Dochan W, Dibley LB, Terry H, Ream E, Norton C. The experience of fatigue in people with inflammatory bowel disease: an exploratory study. J Adv Nurs. 2013;69(9):1987–1999. doi: 10.1111/jan.12060. - DOI - PubMed
1. Norton C, Dibley LB, Bassett P. Faecal incontinence in inflammatory bowel disease: associations and effect on quality of life. J Crohn’s Colitis. 2013;7(8):e302–ee11. doi: 10.1016/j.crohns.2012.11.004. - DOI - PubMed
1. Czuber-Dochan W, Norton C, Bredin F, Darvell M, Nathan I, Terry H. Healthcare professionals’ perceptions of fatigue experienced by people with IBD. J Crohn’s Colitis. 2014;8(8):835–844. doi: 10.1016/j.crohns.2014.01.004. - DOI - PubMed
1. Dibley L, Norton C. Experiences of fecal incontinence in people with inflammatory bowel disease: self-reported experiences among a community sample. Inflamm Bowel Dis. 2013;19(7):1450–1462. doi: 10.1097/MIB.0b013e318281327f. - DOI - PubMed

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources