Title: A Randomized Trial to Evaluate a Co-Created Health Promotion Intervention for Immigrants with Type 2 Diabetes
Introduction: Engaging end users can help overcome barriers to effective health promotion for type 2 diabetes. The DIABETHIC project, funded by the European Union and the Italian Ministry of Health, includes a multicenter randomized controlled trial (RCT) to evaluate a health promotion intervention designed for immigrants with type 2 diabetes. This protocol outlines the co-creation process and the challenges in assessing such interventions.
Methods and Analysis: From November 2023 to July 2024, four primary care centers in Italy will recruit 200 immigrants with type 2 diabetes. Participants will be randomly assigned to either standard health promotion practices or the new co-created intervention. Key outcomes will include changes in glycated hemoglobin, Body Mass Index (BMI), diet, physical activity, and adherence to therapy, measured 12 months after recruitment. The participatory process, supported by qualitative research experts, will focus on three main areas: diet, physical activity, and therapeutic adherence. The intervention will be developed through interviews, focus groups, and role-plays involving patients, healthcare workers, and social service representatives. Barriers to health promotion will be prioritized based on their importance and feasibility. The intervention will standardize key functions, such as dietary counseling and culturally tailored materials, while allowing flexibility in implementation based on local needs. (Trial registration: ClinicalTrials.gov ID NCT06131411).
Opportunities for Improvement: Analyze trial data to identify inefficiencies and growth opportunities. Define measurable outcomes to set clear goals for clinics and patients, such as improving diagnosis speed, reducing costs, or enhancing patient care.
AI Tools for Clinical Needs: Select AI solutions tailored for specific tasks, including predictive analytics, automated documentation, or patient monitoring.
Implementation Strategy: Begin with a pilot project, monitor results, and expand AI solutions based on performance and real-world impact.
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