Trial reportHealth expectations : an international journal of public participation in health care and health policy2025
The REDUCE Intervention: The Development of a Person-Centred Cognitive Behavioural Intervention to Improve Ulcer Outcomes in People at Risk of Diabetic Foot Ulceration.
Trial report in Health expectations : an international journal of public participation in health care and health policy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
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Who cites it
2 citing papers in PubMed.
- The REDUCE Intervention: The Development of a Person-Centred Cognitive Behavioural Intervention to Improve Ulcer Outcomes in People at Risk of Diabetic Foot Ulceration.Health expectations : an international journal of public participation in health care and health policy · 2025Trial
- Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
introductionDiabetic foot ulcers (DFUs) affect approximately one-quarter of people living with diabetes. They are chronic, recur frequently and are associated with significant psychological distress and behavioural challenges. The REDUCE intervention is a person-centred, cognitive behavioural intervention designed to reduce the risk of DFU recurrence and support ulcer healing. Here, we describe the iterative development and optimisation of REDUCE, from its inception as a group-based intervention to an individually tailored intervention delivered via video call or telephone. We outline key stages of the intervention development, including the integration and modification of a digital maintenance intervention (DMI) designed to support long-term behaviour change and a mixed-methods external pilot trial which informed a full-scale clinical and cost-effectiveness trial.
methodsAfter initial development, the DMI was the subject of nine 'think-aloud' interviews with patient and public contributors. We conducted an external pilot randomised controlled trial, involving 20 patients with recently healed DFUs randomised in a 2:1 ratio (REDUCE + Usual Care vs. Usual Care only). Data collection included patient-reported outcome measures (baseline and 6 weeks and 3 months post-randomisation) and qualitative interviews with participants and facilitators.
resultsThink-aloud interviews informed key refinements to the DMI to enhance usability and engagement. The pilot trial demonstrated high acceptability of the intervention format and delivery. Patient-reported outcomes suggested positive trends in psychological well-being, footcare behaviours and mood among intervention participants. Qualitative findings highlighted the value of individualised delivery, the importance of facilitator support and varied engagement with the DMI. These insights informed further refinements to REDUCE ahead of a full-scale effectiveness trial.
conclusionWe provide a comprehensive account of the evolution of the REDUCE intervention and share broader learnings regarding the development of complex behavioural health interventions. The example of REDUCE highlights the value of iterative, multidisciplinary methods and patient involvement in intervention design and offers practical insights for designing digital and remote health interventions. PATIENT OR PUBLIC CONTRIBUTION: Patient and public contributors were involved throughout the research described in this manuscript. Key areas of involvement included co-creation of all patient-facing materials, intervention development and informing trial methods.
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