# Process evaluation findings contradict RCT results of the IBD‐BOOST digital self‐management intervention for fatigue, pain and faecal urgency in inflammatory bowel disease: A mixed methods study of patient perspectives

## TL;DR

A digital self-management program for inflammatory bowel disease was well-received by patients despite not showing significant benefits in a clinical trial.

## Contribution

The study reveals a discrepancy between patient-reported benefits and RCT results, highlighting the importance of patient perspectives in digital health interventions.

## Key findings

- Participants reported high satisfaction and perceived improvements in quality of life and symptom management.
- Low adherence to the intervention was observed in quantitative data despite positive qualitative feedback.
- Patients strongly supported making the intervention freely available for inflammatory bowel disease.

## Abstract

This parallel process evaluation examined the implementation of a randomised controlled trial (RCT) of IBD‐BOOST—a digital, interactive, facilitator‐supported self‐management intervention targeting fatigue, pain and urgency/faecal incontinence in individuals with inflammatory bowel disease (IBD). The RCT, involving 780 participants, compared IBD‐BOOST with usual care but found no significant differences in quality of life (QoL) or symptom relief at six months post‐randomisation.

A concurrent mixed methods design was employed. Qualitative data were gathered through semi‐structured interviews; quantitative data were derived from the intervention platform's built‐in analytics. Qualitative data were analysed using narrative thematic and framework analysis; quantitative data were examined using descriptive statistics.

Interviews were conducted with participants pre‐ (n = 30) and post‐intervention (n = 28). At baseline, participants highlighted a need for improved education and support targeting fatigue, pain and urgency/faecal incontinence, expressing a preference for digital delivery due to its flexibility. Post‐intervention, treatment group interviewees reported high satisfaction with the intervention's content and structure, with many continuing to use the strategies learned, reporting enhanced symptom management and QoL. However, quantitative data indicated low adherence. Control group interviewees expressed disappointment with their allocation but anticipated benefits from deferred access to the intervention.

Although the RCT found no statistically significant effect of IBD‐BOOST on primary outcomes, the process evaluation results revealed perceived benefits in symptom understanding and developing new management strategies. The intervention was well‐received, and patients reported improvements in QoL. There was strong patient support for the IBD‐BOOST intervention to be freely available to all individuals with IBD.