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

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.

Opioid use and associated factors in 1676 patients with inflammatory bowel disease: a multicentre quality improvement project

“…Pain management should be patient-centred, including the use of non-pharmacological approaches such as behavioural therapies and lifestyle modifications. The role of guided self-management as an additional, accessible approach will be revealed with the impending results of the IBD BOOST research project 32. Invaluable resources for clinicians include ‘Opioids Aware: Tapering and Stopping’,33 ‘Surgery and Opioids: Best Practice Guidelines 2021’8 and Levy et al ’s ‘An international multidisciplinary consensus statement on the prevention of opioid-related harm in adult surgical patients’34 while localised primary care guidelines such as ‘Dorset CCG Opioid Prescribing for Chronic Pain: Resource Pack 2018’35 and Oxford University Hospital NHS Foundation Trust’s ‘Guidance for opioid reduction in primary care’36 are tailored to include local resources and support.…”

Supported Intervention Versus Intervention Alone for Management of Fecal Incontinence in Patients With Inflammatory Bowel Disease

“…Our experiences have informed a larger program of study to develop and deliver an online self-management intervention for people with IBD. 48…”

A Novel Digital Self-management Intervention for Symptoms of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease: Describing the Process of Development

“…This comprehensive and iterative approach to intervention development is argued to facilitate the effectiveness and efficacy of a complex health intervention and its long-term implementation [ 76 ]. BOOST is now being tested in a National Institute for Health Research–funded large-scale RCT [ 42 ].…”

“…This step was aimed at assessing whether and how the intervention functions to deliver the desired outcomes. As this intervention was developed as part of a program grant, the substantive part of the assessment of processes and outcomes came after the intervention was developed and is being assessed in multiple stages [ 22 , 42 ]. However, initial assessments of the feasibility of the intervention were included in the preliminary intervention development process.…”