The Reduce Intervention
The Development of a Person‐Centred Cognitive Behavioural Intervention to Improve Ulcer Outcomes in People at Risk of Diabetic Foot Ulceration
Datos Bibliográficos
INTRODUCTION: Diabetic 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. METHODS: After 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. RESULTS: Think-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. CONCLUSION: We 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
Cognition · Diabetes mellitus · Diabetic foot ulcer · Public health · Public involvement · Randomized controlled trial · Diabetes Management and Education · Diabetic Foot Ulcer Assessment and Management · Diagnosis and Treatment of Venous Diseases
The Person-Based Approach to Intervention Development
Guidance on how to develop complex interventions to improve health and healthcare
The Brief Illness Perception Questionnaire
Whatever happened to qualitative description?
Consort 2010 statement
Evaluating the psychometric properties of the mental health Continuum‐Short Form (MHC‐SF)
GRIPP2 reporting checklists
A Brief Measure for Assessing Generalized Anxiety Disorder
The PHQ-9
Developing and evaluating complex interventions
The cost-effectiveness of digital health interventions
Psychometric Properties and Factor Structure of a Long and Shortened Version of the Cognitive and Behavioural Responses Questionnaire
The International Physical Activity Questionnaire modified for the elderly
Using thematic analysis in psychology
Basics of Qualitative Research
New Well-being Measures
| Velocidad de citación | historical |
|---|---|
| Altamente citado | No |