Added value from the grant
As described above, we conducted several additional pieces of work not anticipated in the original grant application, published in papers 3,9 4,10 7, 13 16–22.23–29
Planned future work
Further work planned from the survey data
Two PhD students are planning further analysis of the survey data: one is exploring associations and effect on QoL of IBD fistulas and the other IBD pain. Additionally, we are planning to copy our survey data set to the IBD-BioResource so that people they recruited to our survey can have data on symptoms added to their record, enabling other researchers to search for people with specific symptoms or combinations of symptoms and explore genetic associations, or recruit people with specific symptoms to future research studies.
Further work planned on the IBD-BOOST intervention
As the RCT yielded negative results, it is not warranted to make it freely available as originally planned. In addition, the digital landscape has changed hugely since our application, and it is now necessary to have online health interventions obtain regulatory approvals before making them available. We are therefore applying for additional funding to have the intervention translated into a mobile phone APP, for which we can then seek approvals and implementation routes. As our subgroup analyses indicated people with symptoms of urgency/FI were likely to benefit, we plan to apply for a grant to evaluate the intervention in this group as well as attempting to increase adherence to completing intervention sessions as those who completed four or more sessions were more likely to benefit.
Additionally, we are conducting a mediated moderation analysis of the RCT data to see if it casts more light on our results.
Individual training and capacity-strengthening activities
We ran a workshop at a British Society of Gastroenterology research meeting to train nurses to act as local principal investigators (PIs) for our studies, and 17 nurses (of our 24 PIs) acted in this capacity (see Appendix 3).
IBD-BOOST has contributed to research training of 22 students who were attached to the programme:
Caroline French: Queen Mary University of London (QMUL), PhD on process evaluation in RCTs: IBD-BOOST was one of her three case studies; our team participated in observations and interviews.
Mollie Payne: King's College London (KCL), statistical PhD on dose response modelling in complex interventions (ongoing).
Chris Roukas: QMUL (2026), PhD study on health economic aspects of IBD.
Natasha Seaton: KCL (2025), PhD study on association between inflammation and depression.
Louise Sweeney: KCL (2021), PhD; developed and tested the pain elements of the intervention.
We also had 18 BSc or MSc students attached to the programme, many of them contributing to publications, including 3 as first author: Honzlova, Proudfoot, Matthias (see Appendix 3).
Additional funding
Bowel Research UK funded the programme’s health economist Chris Roukas for a PhD on the Health economics of IBD (2022–5). This led to additional original work on the cost of IBD in the UK and to further development of the IBD-Resource Use Questionnaire developed in the programme.
Study within a trial: the RCT participated in the MRC programme and obtained £5000 to conduct a SWAT comparing standard versus short PIL (see paper 16).23 These data will be pooled with other studies in this MRC programme.
Equality, diversity and inclusion
By developing an online intervention, we intended it to be available to people from the widest possible geographical area, not just those able to travel to clinical sites. This is important in people with IBD and symptoms of urgency and fatigue as travel can be difficult. However, by its nature, a digital intervention is only available to those who can access the internet. The IBD-BOOST intervention is accessible on a mobile phone, but this ideally needs to be viewed on a computer or tablet. We deliberately made character names and cartoon figures in the intervention unisex and diverse.
Inflammatory bowel disease prevalence is highest in Caucasian populations, but its incidence is growing in people in the UK from other ethnic backgrounds. Most participants in our studies were of White British ethnicity, as is usual in UK health research. For our qualitative studies (WP1 and RCT process evaluation), we used purposive sampling and selected as many participants as we could from other backgrounds. Our PPI participants were from various backgrounds, and our PPI conference copresenter was from a non-White ethnicity.
By using extensive PPI in developing our patient-facing materials, including the intervention, we attempted to make these accessible to as wide a range of people as possible. We carefully checked reading age for all elements of our IBD-BOOST intervention. However, we had to balance this with the inevitable complexity of communicating CB concepts: too low a reading age or too simplistic language would undermine the intervention content.
We have reported ethnic, age and gender characteristics in all of our academic papers. IBD prevalence is roughly equal in women and men. Broadly, women and White participants are over-represented, and men and minorities are under-represented in our studies. Future work could consider the diversity of disease severity and length of time since diagnosis and diversity of facilitators.
Our research team was diverse, especially in the students attached to the programme (see Appendix 3).
Climate, health and sustainability
This was not a requirement when we originally applied and so we did not address this directly. However, we developed mostly paperless research and interventions, with minimal or no travel involved. The landscape for digital health has changed considerably since we started, and technology advances are accelerating. People increasingly expect material to be available as APPs for mobile phones, and our intervention could be adapted for this. However, regulation of digital health has also commenced and any intervention now needs to be Conformité Européenne-marked and Medicines and Healthcare products Regulatory Agency-approved, which we have not yet secured. Therefore, our original plan of making IBD-BOOST freely available via the charity CCUK is not currently viable.
Impact and learning (what was and what was not successful in the programme)
Successes
Working closely with people living with IBD, including PPI colleagues, particularly in developing the IBD-BOOST intervention.
Raising awareness in the IBD community of the high prevalence and impact of symptoms of fatigue, pain and urgency/FI via our survey results.
Optimise suggests that many more people with IBD and symptoms of fatigue, pain and urgency/FI need clinical assessment for potentially reversible causes of these symptoms.
Intervention participants reported benefits via our qualitative process evaluation work and facilitators adhered closely to their expected roles.
What was not successful
It was naturally disappointing that the RCT did not find a significant difference between our intervention and CAU. However, there was a lot of learning acquired in the process.
Implications for decision-makers
Our survey results suggest that fatigue, pain and urgency/FI are very common in IBD and that patients want help for these symptoms. This is not currently adequately addressed in primary or secondary care services.
Our medical optimisation study suggests that it is feasible for IBD nurses to review a patient-completed checklist and to follow an algorithm to initiate tests or interventions to address these symptoms. Both patients and nurses were supportive of this approach.
Our RCT did not find that the IBD-BOOST online programme provided benefit over CAU for these symptoms. However, some benefits were observed on secondary outcomes, including generic health-related QoL. There was a small improvement in quality-adjusted life-years and costs with intervention were lower, although not statistically significantly, so resulting in an indication of a cost-effective intervention.
- It is important for HCPs managing patients with IBD to recognise the huge unmet need presented by entangled symptoms of fatigue, pain, urgency and FI, as well as by anxiety and depression. These significantly influence QoL and are not fully explained by disease activity.
- These symptoms should be proactively enquired about and systematically assessed (and periodically reassessed) routinely. Clinical systems need an auditable way of flagging the need for assessment and the resulting outcomes and actions.
- There is a need for increased capacity, training and access to specialist nurses for people living with IBD to enable addressing symptoms early and effectively.
- Early intervention may have a role in preventing symptoms becoming chronic and vicious cycles of symptoms becoming established.
- Patients with significant symptoms should be screened for active disease, and if identified, a supportive multidisciplinary management plan should be offered.
- IBD-BOOST is an online easy to access self-management programme supported by nurses or other trained healthcare staff. We need to adapt this to an updated version (likely a smartphone APP) that encourages engagement and compliance and meets current regulatory requirements for software as a medical device. Outcomes should be assessed regularly to enhance the programme through patient and nurse feedback.
- IBD-BOOST improved generic health-related QoL and resulted in lower, though not statistically significant, healthcare costs and other costs, and a high likelihood of being cost-effective.
- Health benefits and cost savings from the healthcare service perspective may be greater in people with IBS.
- There is a need to explore sustainable models for delivery of digital interventions which fit with the NHS plans for moving more care to community and digital delivery modes.
Research recommendations (listed in order of priority)
- How can the online IBD-BOOST self-management programme be optimised to encourage engagement and adherence? For example:
- Test increased facilitator input in order to increase adherence to the intervention, as CACE analysis suggested that those who adhered achieved better results and to use MOST methodology to explore type and dose of HCP support to enhance effects.
- Study the costs of implementation of IBD-BOOST either as part of the clinical management of patients with IBD or provided as an external add-on programme.
- Explore different modes of delivery, tackling symptoms individually rather than together, and clinic versus volunteer recruitment, as well as selectively recruiting those with most severe symptoms/capacity to benefit.
- What are the biopsychosocial predictors of the presence and progression of symptoms of fatigue, pain and FI? We need to improve our understanding of the physiological and psychological mechanisms underlying fatigue, pain and urgency/FI in IBD.
- Can development of fatigue, pain and FI be predicted at an earlier stage after IBD disease onset? If so, can preventative strategies be developed at an early stage to prevent development of these symptoms and associated morbidity?
- Test Optimise for clinical effectiveness. Can ‘Optimise’ be incorporated into clinical settings (including primary care) or developed into user-enabled clinical systems using latest technology? Can this expedite help-seeking and specialist review?
- Further research to develop evidence-based information for IBD patients to self-manage symptoms.
- What should be the role of patient education in a patient self-management programme and how should it be delivered? Is there a role for Artificial Intelligence-operated programmes aimed at individual educational level and learning styles?
- People with comorbid IBS and IBD appear to have a higher symptom severity and psychological distress and poorer QoL. What are the prospective risk factors for developing IBS in IBD and can they be prevented?
- Study the causes and subtypes of FI and urgency which affect the majority of people with IBD, yet very little is known about causes, subtypes and how to manage it.