Trial reportPloS one2026
Supporting patients using a digital self-management intervention for symptoms of fatigue, pain, and urgency/incontinence in Inflammatory Bowel Disease: a mixed methods process evaluation of trial facilitators.
Trial report in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA randomised controlled trial (RCT) of a facilitator-supported digital programme (IBD-BOOST) for symptom management in Inflammatory Bowel Disease found no difference in disease-specific quality of life and symptom relief compared with controls. Process evaluation is necessary to inform the interpretation of trial outcomes. This study evaluated facilitator adherence to intervention delivery and facilitator perspectives on training, intervention delivery and supervision during the trial, and implementation.
methodsA mixed-methods process-evaluation study nested within an RCT. A randomised sample of participant-facilitator in-programme messages during the intervention were assessed using a bespoke fidelity assessment framework. Semi-structured interviews were conducted with nineteen facilitators pre and post intervention delivery and assessed using reflexive thematic analysis.
resultsFacilitators adhered to the trial protocol for intervention delivery achieving high fidelity throughout. Qualitative interviews revealed facilitators valued the IBD-BOOST intervention and felt the training and on-going supervision equipped them well for the task. Facilitators expressed concerns regarding workload-related time constraints during the trial and cautioned that similar implementation challenges may arise if the intervention were delivered within routine clinical care.
conclusionThis process evaluation demonstrated that, although the overall trial outcomes were unsuccessful, this was not attributable to facilitator infidelity in intervention fidelity or a lack of enthusiasm for the intervention. Instead, other factors, including participant engagement, may have played a significant role in the limited effectiveness observed. Further investigation is needed to identify and address these contributing factors, which could include barriers to participant engagement or potential misalignment between the intervention design and the needs and expectations of its target population.
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