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

Autor(es)

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.

• Tipo de documento: Artigo Científico
• Fonte: SCIENTIFIC REPORTS; v. 14, n. 1, p. 10-pg., 2024-07-12.

Resumo

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)

• Processo FAPESP: 21/00807-8 - Tecnologia de reabilitação para prevenção de disfunções musculoesqueléticas e tratamento dos pés de pessoas com Diabetes: FOotCAre (FOCA) prova de conceito e análise de custo-utilidade
• Beneficiário: Ronaldo Henrique Cruvinel Júnior
• Modalidade de apoio: Bolsas no Brasil - Doutorado Direto
• Processo FAPESP: 17/17848-3 - Efeitos do fortalecimento dos músculos dos pés na atividade física de vida diária e funcionalidade de tornozelo e pé de pessoas com polineuropatia diabética: um ensaio clínico controlado randomizado
• Beneficiário: Renan Lima Monteiro
• Modalidade de apoio: Bolsas no Brasil - Doutorado
• Processo FAPESP: 19/02522-0 - Tecnologia de reabilitação para prevenção de disfunções musculoesqueléticas e dos pés de pessoas com Diabetes Mellitus: ensaio FootCAre (FoCa) preventivo controlado randomizado
• Beneficiário: Jane Suelen Silva Pires Ferreira
• Modalidade de apoio: Bolsas no Brasil - Doutorado