Educational Interventions on Diabetic Foot Self-Care: A Study Protocol for a Pragmatic Randomized Controlled Trial

ABSTRACT

Diabetic foot is one of the most serious complications of diabetes and foot ulcer recurrence has been associated with poor foot care. Educational programs may work as a vehicle for promoting knowledge and adequate foot self-care behaviors, reducing potential ulcerative complications in the diabetic foot, and promoting a better quality of life. This study protocol will analyze the impact of two different educational strategies – an instructive video (Experimental Group 1) compared to a foot care leaflet with real-time guided reading (Experimental Group 2) and standard care (Control Group) – on adherence and knowledge about diabetic foot care and patients’ perception of their foot health. This study is a Pragmatic Randomized Controlled Trial of a non-pharmacological treatment. Participants need to have a diabetic foot diagnosis and attend a Diabetic Foot Multidisciplinary Consultation at two hospitals from the North of Portugal. Participants will be assessed at the first appointment of the diabetic foot consultation (T0), two weeks after (T1), and three months later, at follow-up (T2). Primary outcomes will be adherence and knowledge about diabetic foot care and general foot health. Secondary outcomes will be illness representations regarding diabetic foot. The results of this study will inform educational interventions to decrease diabetic foot ulcers, amputation rates, and the costs associated with both, contributing to foot care adherence and improve patient’s quality of life.

Acknowledgements

The authors want to thank to Maria de Jesus Dantas, MD, from the Centro Hospitalar do Tâmega e Sousa and Rui Carvalho, MD, from the Centro Hospitalar Universitário do Porto, for their support and availability to conduct this study in the respective Multidisciplinary Consultation of Diabetic Foot.

Disclosure statement

No potential conflict of interest was reported by the authors.

Authors’ contributions

All the authors participated in the concept and design of the trial, and data analysis plan. GF participated in drafting the manuscript. All the authors read, critically revised, and approved the final manuscript.

Trial Registration

ClinicalTrials.gov, ID: NCT04811989.

Additional information

Funding

This study was conducted at the Psychology Research Centre (CIPsi/UM) School of Psychology, University of Minho, supported by the Foundation for Science and Technology (FCT) through the Portuguese State Budget (UIDB/01662/2020) and by a PhD fellowship from FCT assigned to the first author (SFRH/BD/131780/2017).