Affordable web-based foot-ankle exercise program proves effective for diabetic foot care in a randomized controlled trial with economic evaluation

Author(s)

Cruvinel-Junior, Ronaldo H. ; Ferreira, Jane S. S. P. ; Verissimo, Jady L. ; Monteiro, Renan L. ; Silva, erica Q. ; Suda, Eneida Y. ; Sacco, Isabel C. N.

• Document type: Journal article
• Source: SCIENTIFIC REPORTS; v. 14, n. 1, p. 10-pg., 2024-07-12.

Abstract

The aim of this study was to shed light on a crucial issue through a comprehensive evaluation of the cost-effectiveness and cost-utility of a cutting-edge web-based foot-ankle therapeutic exercise program (SOPeD) designed for treating modifiable risk factors for ulcer prevention in individuals with diabetes-related peripheral neuropathy (DPN). In this randomized controlled trial, 62 participants diagnosed with DPN were assigned to the SOPeD software or received usual care for diabetic foot. Primary outcomes were DPN symptoms and severity, foot pain and function, and quality-adjusted life years (QALYs). Between-group comparisons provided 95% confidence intervals. The study also calculated incremental cost-effectiveness and cost-utility ratios (ICERs), analyzed direct costs from a healthcare perspective, and performed a sensitivity analysis to assess uncertainty. The web-based intervention effectively reduced foot pain, improved foot function and showed favorable cost-effectiveness, with ICERs ranging from (USD) $5.37-$148.71 per improvement in different outcomes. There is a high likelihood of cost-effectiveness for improving DPN symptoms and severity, foot pain, and function, even when the minimum willingness-to-pay threshold was set at $1000.00 USD. However, the intervention did not prove to be cost-effective in terms of QALYs. This study reveals SOPeD's effectiveness in reducing foot pain, improving foot function, and demonstrating cost-effectiveness in enhancing functional and clinical outcomes. SOPeD stands as a potential game-changer for modifiable risk factors for ulcers, with our findings indicating a feasible and balanced integration into public health systems. Further studies and considerations are vital for informed decisions to stakeholders and the successful implementation of this preventive program on a larger scale.Trial Registration: ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019. (AU)

• FAPESP's process: 21/00807-8 - Rehabilitation technology for prevention of foot musculoskeletal dysfunctions and treatment of people with Diabetes Mellitus: FOotCAre (FOCA) proof of concept and cost-utility analysis
• Grantee: Ronaldo Henrique Cruvinel Júnior
• Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
• FAPESP's process: 17/17848-3 - Effects of foot muscle strengthening in daily activity and functionality of foot and ankle in diabetic polyneuropathy patients: a randomized controlled trial
• Grantee: Renan Lima Monteiro
• Support Opportunities: Scholarships in Brazil - Doctorate
• FAPESP's process: 19/02522-0 - Rehabilitation technology for prevention of musculoskeletal and foot dysfunctions of people with Diabetes Mellitus: FootCAre (FoCa) prevention randomized controlled trial
• Grantee: Jane Suelen Silva Pires Ferreira
• Support Opportunities: Scholarships in Brazil - Doctorate