Multicenter randomized clinical trial to analyze the efficay of the spanish national healthcare system intervention to reduce frailty status in prefrail or frail older adults (FRAILMERIT). Study protocol
e202501001
Keywords:
Frailty, Randomized clinical trial, Primary Care, Exercise, Nutrition, Older adultsAbstract
BACKGROUND // Frailty is a common and relevant condition in community-dwelling older adults, with high implications for adverse health outcomes. However, the intervention recommended by the Spanish National Healthcare System has not been yet tested. The main objective is to determine the efficacy of this intervention in reducing frailty in community-dwelling older adults.
METHODS // A multicenter randomized clinical trial in 290 pre-frail or frail community-dwelling older adults over sixty-nine years of age of twenty-four selected Primary Healthcare teams in Spain will be carried out. Randomization will be carried out by clusters with a 1:1 ratio, each cluster being a different Primary Care center to avoid contamination. All the instrumentation will be done in accordance with the guidelines of the 2022 Document of the Spanish Ministry of Health for the prevention of frailty. The intervention will consist of a multicomponent physical exercise program in small groups of six older adults, a nutritional intervention, and an educational program for Primary Care teams, in two three-month periods, separated by two months. Follow-up period will be eight months, and the main outcome variable will be the change in frailty status measured with the frailty phenotype and the Short Physical Performance Battery (SPPB). Analysis will be conducted under an intention-to-treat methodology. Quality of life changes, use of healthcare resources, and cost-effectiveness of the program will be analyzed.
CONCLUSIONS // Results of the clinical trial will allow determining the efficacy and cost-effectiveness of the interventions proposed by the Spanish National Healthcare System to prevent and treat frailty.
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Copyright (c) 2025 Almudena Avendaño Céspedes, Rafael García Molina, Rubén Alcantud Córcoles, Adriana Abizanda Saro, Maximiliano Martínez Ramírez, Ignacio Morón Merchante, Manuel Maestre Moreno, Antonio Aragonés Jiménez, Beatriz Rodríguez Sánchez, Pere Torán Monserrat, Pedro Abizanda Soler, Grupo de Estudio FRAILMERIT
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