{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T20:03:39Z","timestamp":1780085019494,"version":"3.54.0"},"reference-count":47,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,9,18]],"date-time":"2025-09-18T00:00:00Z","timestamp":1758153600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Health Expectations"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Diabetic foot ulcers (DFUs) affect approximately one\u2010quarter 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\u2010centred, 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\u2010based 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\u2010term behaviour change and a mixed\u2010methods external pilot trial which informed a full\u2010scale clinical and cost\u2010effectiveness trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>After initial development, the DMI was the subject of nine \u2018think\u2010aloud\u2019 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\u2009+\u2009Usual Care vs. Usual Care only). Data collection included patient\u2010reported outcome measures (baseline and 6 weeks and 3 months post\u2010randomisation) and qualitative interviews with participants and facilitators.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Think\u2010aloud 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\u2010reported outcomes suggested positive trends in psychological well\u2010being, 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\u2010scale effectiveness trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patient or Public Contribution<\/jats:title>\n                    <jats:p>Patient and public contributors were involved throughout the research described in this manuscript. Key areas of involvement included co\u2010creation of all patient\u2010facing materials, intervention development and informing trial methods.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hex.70434","type":"journal-article","created":{"date-parts":[[2025,9,18]],"date-time":"2025-09-18T15:04:53Z","timestamp":1758207893000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["The REDUCE Intervention: The Development of a Person\u2010Centred Cognitive Behavioural Intervention to Improve Ulcer Outcomes in People at Risk of Diabetic Foot Ulceration"],"prefix":"10.1111","volume":"28","author":[{"given":"Kavita","family":"Vedhara","sequence":"first","affiliation":[{"name":"School of Psychology Cardiff University Cardiff UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debbie","family":"Brewin","sequence":"additional","affiliation":[{"name":"Institute of Psychiatry, Psychology &amp; Neuroscience (IoPPN) King's College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran","family":"Game","sequence":"additional","affiliation":[{"name":"Royal Derby Hospital University Hospitals of Derby and Burton Foundation Trust Derby UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Sheehan","sequence":"additional","affiliation":[{"name":"Centre for Academic Primary Care, School of Medicine University of Nottingham Nottingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kieran","family":"Ayling","sequence":"additional","affiliation":[{"name":"Centre for Academic Primary Care, School of Medicine University of Nottingham Nottingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kat","family":"Bradbury","sequence":"additional","affiliation":[{"name":"School of Psychology University of Southampton Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Slodkowska\u2010Barabasz","sequence":"additional","affiliation":[{"name":"School of Primary Care, Population Sciences and Medical Education University of Southampton Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Joseph","sequence":"additional","affiliation":[{"name":"School of Psychology University of Southampton Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2129-9163","authenticated-orcid":false,"given":"Ruth","family":"Hart","sequence":"additional","affiliation":[{"name":"Usher Institute University of Edinburgh Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"Mitchell","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences University of York York UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Lawton","sequence":"additional","affiliation":[{"name":"Usher Institute University of Edinburgh Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trudie","family":"Chalder","sequence":"additional","affiliation":[{"name":"Institute of Psychiatry, Psychology &amp; Neuroscience (IoPPN) King's College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,9,18]]},"reference":[{"key":"e_1_2_15_2_1","unstructured":"NHS England.2023.Health Survey for England 2021 Part 2 accessed January 15 2025 https:\/\/digital.nhs.uk\/data-and-information\/publications\/statistical\/health-survey-for-england\/2021-part-2\/adult-health-diabetes."},{"key":"e_1_2_15_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1615439"},{"key":"e_1_2_15_4_1","unstructured":"NHS England.2018.National Diabetes Foot Care Audit\u20142014\u20132017 accessed January 15 2025 https:\/\/www.digital.nhs.uk\/catalogue\/PUB30249."},{"key":"e_1_2_15_5_1","unstructured":"National Institute for Health and Care Excellence (NICE).Diabetic Foot Problems: Prevention and Management NICE Guideline [NG19] accessed January 15 2025 https:\/\/www.nice.org.uk\/guidance\/NG19."},{"key":"e_1_2_15_6_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc06-2313"},{"key":"e_1_2_15_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-5491.2002.00698.x"},{"key":"e_1_2_15_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.brat.2012.02.013"},{"key":"e_1_2_15_9_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2022.787135"},{"key":"e_1_2_15_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2017-019865"},{"key":"e_1_2_15_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.a1655"},{"key":"e_1_2_15_12_1","doi-asserted-by":"publisher","DOI":"10.2196\/jmir.4055"},{"key":"e_1_2_15_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780470694008.ch11"},{"key":"e_1_2_15_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13012-017-0553-4"},{"key":"e_1_2_15_15_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0196868"},{"key":"e_1_2_15_16_1","doi-asserted-by":"publisher","DOI":"10.2196\/jmir.6601"},{"key":"e_1_2_15_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2015-009769"},{"key":"e_1_2_15_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)60127-1"},{"key":"e_1_2_15_19_1","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/561320"},{"key":"e_1_2_15_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6947-10-52"},{"key":"e_1_2_15_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2020.100442"},{"key":"e_1_2_15_22_1","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.230274"},{"key":"e_1_2_15_23_1","unstructured":"N.Mitchell K.Vedhara K.Ayling et al. \u201cReducing the Impact of Diabetic Foot Ulcers (REDUCE): A Randomised Controlled Pilot Trial \u201d unpublished manuscript 2025."},{"key":"e_1_2_15_24_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i5239"},{"key":"e_1_2_15_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychores.2005.10.020"},{"key":"e_1_2_15_26_1","doi-asserted-by":"publisher","DOI":"10.1177\/17449871231208108"},{"issue":"1","key":"e_1_2_15_27_1","first-page":"37","article-title":"The Provisions of Social Relationships and Adaptation to Stress","volume":"1","author":"Cutrona C. 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