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

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

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.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05466-4.

Related collections

Most cited references 58

Record: found
Abstract: found
Article: not found

Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

M. Herdman, C. Gudex, S Lloyd … (2011)

Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.

0 comments Cited 2556 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: found

The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions.

Susan Michie, Michelle Richardson, Marie Johnston … (2014)

CONSORT guidelines call for precise reporting of behavior change interventions: we need rigorous methods of characterizing active content of interventions with precision and specificity. The objective of this study is to develop an extensive, consensually agreed hierarchically structured taxonomy of techniques [behavior change techniques (BCTs)] used in behavior change interventions. In a Delphi-type exercise, 14 experts rated labels and definitions of 124 BCTs from six published classification systems. Another 18 experts grouped BCTs according to similarity of active ingredients in an open-sort task. Inter-rater agreement amongst six researchers coding 85 intervention descriptions by BCTs was assessed. This resulted in 93 BCTs clustered into 16 groups. Of the 26 BCTs occurring at least five times, 23 had adjusted kappas of 0.60 or above. "BCT taxonomy v1," an extensive taxonomy of 93 consensually agreed, distinct BCTs, offers a step change as a method for specifying interventions, but we anticipate further development and evaluation based on international, interdisciplinary consensus.

0 comments Cited 1688 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: found

Is Open Access

Process evaluation of complex interventions: Medical Research Council guidance

Graham Moore, Suzanne Audrey, Mary Barker … (2015)

Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies

0 comments Cited 1385 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Contributors

Christine Norton:

ORCID: http://orcid.org/0000-0003-2259-0948

Christine.norton@kcl.ac.uk

Jonathan Syred: Jonathan.syred@kcl.ac.uk

Sally Kerry: s.m.kerry@qmul.ac.uk

Micol Artom: micol.artom1@nhs.net

Louise Sweeney: Louise.sweeney@kcl.ac.uk

Ailsa Hart: Ailsa.hart@nhs.net

Wladyslawa Czuber-Dochan:

ORCID: https://orcid.org/0000-0002-9889-1248

Wladzia.czuber-dochan@kcl.ac.uk

Stephanie J. C. Taylor: s.j.c.taylor@qmul.ac.uk

Borislava Mihaylova: b.mihaylova@qmul.ac.uk

Chris Roukas: c.roukas@qmul.ac.uk

Qasim Aziz: q.aziz@qmul.ac.uk

Laura Miller: l.miller@qmul.ac.uk

Richard Pollok:

ORCID: https://orcid.org/0000-0001-6452-6763

Richard.Pollok@nhs.net

Sonia Saxena:

ORCID: https://orcid.org/0000-0003-3787-2083

s.saxena@imperial.ac.uk

Imogen Stagg: i.stagg@nhs.net

Helen Terry: helen.terry@crohnsandcolitis.org.uk

Zohra Zenasni: z.zenasni@qmul.ac.uk

Lesley Dibley: l.b.dibley@greenwich.ac.uk

Rona Moss-Morris: rona.moss-morris@kcl.ac.uk

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 3 August 2021

Publication date PMC-release: 3 August 2021

Publication date Collection: 2021

Volume: 22

Electronic Location Identifier: 516

Affiliations

[1 ]GRID grid.13097.3c, ISNI 0000 0001 2322 6764, King’s College London, ; 57 Waterloo Road, London, SE1 8WA UK

[2 ]GRID grid.4868.2, ISNI 0000 0001 2171 1133, Pragmatic Clinical Trials Unit, , Queen Mary University of London, ; 58 Turner St, Whitechapel, London, E1 2AB UK

[3 ]GRID grid.498467.0, NHS Digital, ; Skipton House, 80 London Road, London, SE1 6LH UK

[4 ]GRID grid.13097.3c, ISNI 0000 0001 2322 6764, Health Psychology Section, , Institute of Psychiatry, Psychology and Neuroscience, King’s College London, ; London, UK

[5 ]GRID grid.416510.7, IBD Unit, , St Mark’s Hospital, ; Watford Road, Harrow, HA13UJ UK

[6 ]GRID grid.4868.2, ISNI 0000 0001 2171 1133, Institute of Population Health Sciences, , Queen Mary University of London, ; 58 Turner St, Whitechapel, London, E1 2AB UK

[7 ]GRID grid.4991.5, ISNI 0000 0004 1936 8948, Nuffield Department of Population Health, , University of Oxford, ; Old Road Campus, Oxford, OX3 7LF UK

[8 ]GRID grid.4868.2, ISNI 0000 0001 2171 1133, 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

[9 ]GRID grid.451349.e, Department of Gastroenterology, , St George’s University Hospitals NHS Foundation Trust and St George’s University of London, ; London, SW17 0QT UK

[10 ]GRID grid.7445.2, ISNI 0000 0001 2113 8111, Department of Primary Care and Public Health Imperial College London, ; London, UK

[11 ]London North West University Hospitals, Watford Road, Harrow, HA1 3UJ UK

[12 ]GRID grid.453704.1, Crohn’s & Colitis UK, ; 1 Bishops Square (Helios Court), Hatfield Business Park, Hatfield, Hertfordshire, AL10 9NE UK

[13 ]GRID grid.36316.31, ISNI 0000 0001 0806 5472, School of Health Sciences, Faculty of Education, Health and Human Sciences, , University of Greenwich, (Avery Hill Campus), ; London, SE9 2UG UK

[14 ]GRID grid.13097.3c, ISNI 0000 0001 2322 6764, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, , King’s College London, ; London, UK

Author information

Christine Norton http://orcid.org/0000-0003-2259-0948

Wladyslawa Czuber-Dochan https://orcid.org/0000-0002-9889-1248

Richard Pollok https://orcid.org/0000-0001-6452-6763

Sonia Saxena https://orcid.org/0000-0003-3787-2083

Article

Publisher ID: 5466

DOI: 10.1186/s13063-021-05466-4

PMC ID: 8329619

PubMed ID: 34344432

SO-VID: ef176393-9c37-4302-955e-664cc709aedf

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 14 November 2020

Date accepted : 16 July 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100000272, National Institute for Health Research;

Award ID: RP-PG-0216-20001

Award Recipient : Christine Norton

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: rct,inflammatory bowel disease,crohn’s disease,ulcerative colitis,fatigue,pain,faecal incontinence,online self-management

Data availability:

ScienceOpen disciplines: Medicine

Keywords: rct, inflammatory bowel disease, crohn’s disease, ulcerative colitis, fatigue, pain, faecal incontinence, online self-management

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

Read this article at

Abstract

Background

Primary research question

Methods

Discussion

Trial registration

Supplementary Information

Related collections

Karger: Gastroenterology

Most cited references 58

Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions.

Process evaluation of complex interventions: Medical Research Council guidance

Author and article information

Contributors

Journal

Affiliations

Author information

Article

History

Funding

Categories

Custom metadata

Comments

Comment on this article

Similar content 74

Cited by 5

Most referenced authors 703