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Clinical Trial Summary

The main objective is evaluate the effectiveness of a Multifactorial Pilot Program on the Prevention of Falls in people aged 65 or over during 4 years at Gerencia de Atención Integrada de Talavera de la Reina.


Clinical Trial Description

Introduction: Falls are a major global public health problem. Falls are the second leading cause of death from unintentional injuries in the world. The highest mortality rates correspond to 60 years old people. 20-30% suffer from moderate-serious injuries (hip fractures, head injuries...), that reduce mobility and independence, increasing the risk of premature death. Moreover, there are more than 400 risk factors. Most can be modified to decrease the risk of falling. Objective: To evaluate the effectiveness of a Multifactorial Pilot Program on the Prevention of Falls in people aged 65 or over during 4 years at Gerencia de Atención Integrada de Talavera de la Reina. Material and methods: Randomized clinical trial with 264 patients is carried out. 65 years old or older patients are recruited from primary care (≥ 1 positive response in the Frailty Screening Test, or ≥ 3 in the Downton Test and > 90 in the Barthel Index). Falls risk is assessed using validated scales. Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO). Control group receive recommendations (physical exercise, health education on risk factors, footwear, exercise, home adaptation, nutrition, …). Variables are presented with their frequency distribution. Qualitative variables as median and range, and quantitatives with their mean and standard deviation. Association between qualitative variables are evaluated with Pearson's Chi-square test. Student's t test be used when the distribution of the variable adjusts to normality. The null hypothesis will be rejected with an error α less than 0.05. Expected benefits: It is expected to reduce the risk of falls in 30-35% of 65 years old people or older in the urban area of Talavera de la Reina. It would mean great savings and improve the quality of life. It is expected to increase the years of healthy life. It is intended to provide health professionals with a tool to make clinical decisions based on evidence on the prevention of falls to be used as a unified work protocol at Gerencia de Atención Integrada de Talavera de la Reina. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05682872
Study type Interventional
Source Castilla-La Mancha Health Service
Contact Nuria García Bonilla
Phone +34638225048
Email ngarciab@sescam.jccm.es
Status Recruiting
Phase N/A
Start date March 9, 2021
Completion date March 9, 2025

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