505-P: A Formative Evaluation to Improve Study Processes and Optimize a Tailored Intervention to Prevent Diabetic Foot Ulcer Recurrence—The Step Up to Avert Amputation Randomized Trial

by sugaradmin



Introduction and Objective: Lower extremity amputation (LEA), a devastating complication of diabetes, is preceded in more than 80% of cases by a diabetic foot ulcer (DFU). Foot-specific care and general diabetes care are necessary to prevent LEA. During the STEP UP randomized clinical trial (RCT), formative evaluation interviews (FEIs) with study participants were conducted to help refine study processes and optimize a tailored behavioral intervention (TI) to prevent DFU recurrence.Methods: At four distinct points in the trial, four to five unique participants were invited to complete an FEI focused on the counseling call, plantar thermometer, foot temperature logbook and foot-care checklist. Once the FEIs were complete, the study team analyzed the interviews to immediately identify actionable feedback to improve the pre-intervention and intervention procedures. Formal thematic analysis was conducted by three independent coders using ATLAS.ti software.Results: Overall, of the 18 participants, most expressed satisfaction with the intervention as it emphasized the importance of foot health and supported adherence to self-monitoring behaviors to prevent DFUs. Primary reasons for participation were gaining accountability, health education, and awareness of their condition. Many found the logbook and checklist straightforward and “easy to use”. Common barriers to adherence were repetitiveness of the calls, difficulties with thermometer use, and forgetfulness. To address these concerns, the questionnaire was shortened, thermometer modifications to improve accessibility were discussed with the manufacturer, and the team worked with participants to devise easy reminders for intervention adherence.Conclusion: Iterative FEIs provided critical information to optimize the STEP UP intervention and study processes, and enhance the participant experience through active troubleshooting.

Disclosure

P.K. Salovaara: None. S. Gunawan: None. M. Rodriguez: None. A. Nicholson: None. S. Natarajan: None.

Funding

VA Rehabilitation R&D (I01RX001858)



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