Título completo: A randomized clinical trial to evaluate the effectiveness of a multi-modal intervention in older people with type 2 diabetes on frailty and quality of life: the MID-Frail study

Subvencionado por: Comisión Europea (HEALTH 2011 2.2.2-1/HEALTH.2011.2.4.3-1-278803)

Subvención concedida: 240.000 €

Duración: 4 años (2012-2015)

Investigador principal: Leocadio Rodríguez Mañas

Investigadores asociados (SESCS): Julio López Bastida, Juan Oliva Moreno

Description:

MID-Frail is a major new international research study examining the effectiveness of combining optimised medical management with exercise and dietary programmes to maintain function and quality of life in people aged 70 years and over who have Type 2 diabetes. Sixteen centres in seven countries across Europe will participate in this 4-year study, which is supported by the European Union. The project is co-ordinated by Professor Leocadio Rodríguez-Mañas (Hospital Universitario de Getafe, Madrid, Spain). The project is organized in 8 Work Packages (WPs):

• WP1. To ensure the proper functioning of the project so that the predefined objectives are met within the proposed timeframe. This WP also deals with the requirements concerning the scientific management of the project.
• WP2. To ensure that the study is internally valid and that any sources of variability, bias or error within each phase of the project are minimised. Several partners are involved in coordinating this activity and additional input from local experts (within each country) will be commissioned to ensure adherence to the requirements of the protocol.
• WP3. To implement, manage and monitor the randomised controlled trial.
• WP4. To define which of the many components of a multimodal intervention will be implemented in this project.
• WP5. To ensure an adequate management and analysis of the data collected so that data recording is timely, complete and accurate.  Both the Statistical and the Health Economic Analysis plans will be finalised before any data is collected. Interim (blinded) reports will be prepared and the final analysis will be done immediately after freezing the database. Final Statistical and Health Economic Analysis Report will be completed.
• WP6. To identify which factors are involved in the development of frailty in people with type 2 diabetes, to assess the effectiveness of the physical intervention and how it impacts on quality of life, and to determine the predictive value of response to treatment for each of the factors identified.  The mechanisms underlying the effectiveness of the intervention, if any, will also be clarified.
• WP7. To achieve maximum exploitation and dissemination of the results obtained in this project. The ways and means by which the project results are to be exploited will be identified. The wide diffusion of the project results from both a scientific and an industrial point of view will be achieved via dissemination processes.
• WP8. To provide resources for effective coordination of all project-related activities and maintenance of contact with Commission representatives.