IMPLEMENTING A CONTEXTUALLY APPROPRIATE INTERVENTION STRATEGY IN PRIMARY CARE FOR THE FOOT OF PEOPLE WITH DIABETES (FOCAIN) - cluster randomized controlled trial

• Grant number: 24/20974-4
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Start date: February 01, 2025
• End date: January 31, 2027
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Isabel de Camargo Neves Sacco
• Grantee: Jane Suelen Silva Pires Ferreira
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated research grant: 23/09860-4 - IMPLEMENTING A CONTEXTUALLY APPROPRIATE INTERVENTION STRATEGY IN PRIMARY CARE FOR THE FOOT OF PEOPLE WITH DIABETES - FOCAIN, AP.PP

Abstract

Diabetes mellitus is a significant public health problem, negatively impacting health and quality of life indicators. Ulcers and amputations are quite common but their prevention has been neglected in SUS practices. The five-year mortality of people with diabetes affected by ulcers is higher than mortality rate for breast cancer. Public policies focused on diabetic foot prevention and care need to be implemented. Despite the Ministry of Health's efforts to implement comprehensive care actions for people with diabetes, there is currently no effective public policy specifically targeting the prevention of modifiable risk factors for ulcers, including foot exercise programs, despite this action being internationally recommended by the International Guidelines for Diabetic Foot Prevention. The proposal "FOot Care and exercises ImplementatioN for people with diabetes in primary care" (FOCAIN) is based on implementation science, which aims to incorporate a contextually appropriate preventive foot program into the Adult Type 2 Diabetes Care Line of the Ministry of Health, specifically in the primary care setting of Limeira, São Paulo. The program will be adapted to the local context, it will capacitate the primary care health professionals, and monitor the clinical outcomes, reach, and adoption by the stakeholders involved in public management, ensuring the steps of the implementation process of a public policy focused on foot care for people with diabetes. A foot-ankle exercises program will be implemented in groups at the Basic Health Units (UBS), in addition to educational actions for foot care. FOCAIN will seek to establish a shared responsibility of care between the primary care teams and eMulti in Limeira and the FOCAIN team. This proposal has the involvement and alignment with the primary care management of Limeira, aiming for regulation and continuity of diabetic foot prevention care. FOCAIN is a hybrid type 2 study implementation-effectiveness, which aims to simultaneously test the clinical intervention and implementation strategy in the primary care setting of Limeira, and will consist of four phases. The first pre-implementation phase will gather information about local characteristics, facilitators, and barriers to implementation, and constitute the implementation team. In the second phase, the implementation team will structure the actions for implementing the intervention, adapting it to the context defined in phase 1, and developing strategies to train healthcare professionals on the proposed clinical intervention through educational groups. In phase 3, the structured clinical intervention will be implemented by the team (cluster randomized controlled trial), either using a software or a booklet with the foot-ankle exercise program, we will monitor the participants' diabetes-related, functional and quality of life outcomes after the 8 weeks of intervention. Reach, adoption, and implementation will be evaluated using the RE-AIM tool (Reach, Effectiveness, Adoption, Implementation, and Maintenance tool). In phase 4 - maintenance, aiming for t autonomy and responsibility of the Limeira Municipal Health Department, the project's actions are expected to be maintained and expanded after the partnership with USP, promoting the sharing of experiences with other public and private institutions, facilitating implementation in other municipalities. The partnership between the Faculty of Medicine of USP and the Limeira Municipal Health Department, was established for the development of FOCAIN. (AU)