NCT05682872

Multifactorial Fall Prevention Program

Multifactorial Fall Prevention Program in People Aged 65 or Over of an Urban Area of Talavera de la Reina

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Castilla-La Mancha Health Service · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Frail Elderly Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Physical exercise program (VIVIFRAIL) supervised by a physiotherapist	Promotion of physical exercise program for frailty and falls prevention in elderly. Muscular strength training, cardiovascular resistance, balance and gait. Initially guided and supervised every 3 months by a physiotherapist.
BEHAVIORAL	Adequacy of the environment	A home study and the environment will be made to diagnose fall risks. Guided and supervised by a occupational therapist during a home visit.
BEHAVIORAL	Polypharmacy review	Assessment of the medication that patients receives related to fall risks proposing its adjustment. Revised by a primary care doctor different from care routine.
BEHAVIORAL	Health education related to falls prevention (4 sessions)	SESSION 1: Fall Risk factors. Pharmacology. Nutrition and falls (Primary Care Doctor and Primary Care Nurse) SESSION 2: Accident prevention through environmental modification (Occupational Therapist) SESSION 3: Importance of physical exercise to prevent falls (Physiotherapist) SESSION 4: Footwear and foot care. How to react to a fall?: what to do and how to get up? (Primary Care Nurse)
BEHAVIORAL	General Assement	General assessment (feet, footwear, nutrition, cognitive/psychological, social of risk factors) carried out by Primary Care Doctor and Primary Care Nurse
BEHAVIORAL	Evaluation of patients by an expert group	Evaluation of the patient by an expert group (Primary care doctor, primary care nurse, polypharmacy review doctor, occupational therapist, frailty group) and decision-making for correction of fall risk factors.
BEHAVIORAL	Information brochures on the importance of physical exercise	Integrated Assistance Process for prevention falls in elderly. Benefits of physical exercise and fall prevention at home. Prepared by the Junta de Comunidades de Castilla-La Mancha and Servicio de Salud de Castilla-La Mancha.
BEHAVIORAL	Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nurse	Promotion of physical exercise program for frailty and falls prevention in elderly. Muscular strength training, cardiovascular resistance, balance and gait. Supervised by primary care doctor o primary care nurse according to passport recommendations.
BEHAVIORAL	Regular assessment and follow-up by primary care doctor and primary care nurse	General assessment related to falls with the established protocols at primary care routine.
BEHAVIORAL	Health education related to falls prevention (1 session)	There will be a single session. The session will cover the following topics: Fall Risk factors. Pharmacology. Nutrition and falls. Accident prevention through environmental modification. Importance of physical exercise to prevent falls. Footwear and foot care. How to react to a fall?: what to do and how to get up?

Timeline

• Start date: 2021-03-09
• Primary completion: 2026-10-09
• Completion: 2026-11-09
• First posted: 2023-01-12
• Last updated: 2025-07-17

Locations

1 site across 1 country: Spain