Evidence map›Paper›PMID 34344432›Full record

ArticleTrials2021

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, Jonathan Syred, Sally Kerry, Micol Artom, Louise Sweeney, Ailsa Hart, Wladyslawa Czuber-Dochan, Stephanie J C Taylor, Borislava Mihaylova, Chris Roukas and 9 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
3.9field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Psychological interventions for treatment of inflammatory bowel disease.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Remote care through telehealth for people with inflammatory bowel disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Framework of IBD Care Delivery Across Ages.Journal of Crohn's & colitis · 2024
    Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 9 institutions in 1 country.

Christine NortonKing's College London, 57 Waterloo Road, London, SE1 8WA, UK. Christine.norton@kcl.ac.uk.ORCID http://orcid.org/0000-0003-2259-0948
Jonathan SyredKing's College London, 57 Waterloo Road, London, SE1 8WA, UK.
Sally KerryPragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
Micol ArtomNHS Digital, Skipton House, 80 London Road, London, SE1 6LH, UK.
Louise SweeneyHealth Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Ailsa HartIBD Unit, St Mark's Hospital, Watford Road, Harrow, HA13UJ, UK.
Wladyslawa Czuber-DochanKing's College London, 57 Waterloo Road, London, SE1 8WA, UK.ORCID https://orcid.org/0000-0002-9889-1248
Stephanie J C TaylorInstitute of Population Health Sciences, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
Borislava MihaylovaInstitute of Population Health Sciences, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
Chris RoukasInstitute of Population Health Sciences, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
Qasim AzizCentre 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.
Laura MillerPragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
Richard PollokDepartment of Gastroenterology, St George's University Hospitals NHS Foundation Trust and St George's University of London, London, SW17 0QT, UK.ORCID https://orcid.org/0000-0001-6452-6763
Sonia SaxenaDepartment of Primary Care and Public Health Imperial College London, London, UK.ORCID https://orcid.org/0000-0003-3787-2083
Imogen StaggLondon North West University Hospitals, Watford Road, Harrow, HA1 3UJ, UK.
Helen TerryCrohn's & Colitis UK, 1 Bishops Square (Helios Court), Hatfield Business Park, Hatfield, Hertfordshire, AL10 9NE, UK.
Zohra ZenasniPragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner St, Whitechapel, London, E1 2AB, UK.
Lesley DibleySchool of Health Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, (Avery Hill Campus), London, SE9 2UG, UK.
Rona Moss-MorrisPsychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Queen Mary University of London · GBKing's College London · GBCrohn's and Colitis UK · GBImperial College London · GBLondon North West Healthcare NHS Trust · GBNHS Digital · GBSt George's, University of London · GBSt Mark's Hospital · GBUniversity of Greenwich · GB

Funding

National Institute for Health Research RP-PG-0216-20001
6 · The paper itself

Abstract

backgroundDespite 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?

methodsA 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 registrationISRCTN71618461 . Registered on 9 September 2019.

Indexed as

Cognitive Behavioral TherapyInflammatory Bowel DiseasesSelf-ManagementAdultFatigueHumansPainPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicCrohn’s diseaseFaecal incontinenceFatigueInflammatory bowel diseaseOnline self-managementPainRCTUlcerative colitis

Identifiers

PMID34344432
PMCPMC8329619
OpenAlexW3167304832

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.