Multifactorial Fall Prevention Program

Not Applicable

Active, not recruiting

• Conditions: Frail Elderly Syndrome

• Registration Number: NCT05682872
• Lead Sponsor: Castilla-La Mancha Health Service

Brief 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.

Study Timeline

• Study Start: 2021-03-09
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-12
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-10-09
• Study Completion: 2026-11-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• 65 years old or older patients
• Live in Talavera de la Reina
• Ability to walk at the Health Center
• ≥ 3 in the Downton Test
• > 90 in the Barthel Index
• Sign the informed consent

Exclusion Criteria

• Patients with an intense physical activity
• Use of a wheelchair
• Amputations or prosthetic limbs
• Deafness
• Blindness
• Moderate or severe cognitive impairment
• Vertebral, pelvic or lower limb fractures in the 12 months prior to entering the program
• Absolute contraindication to physical exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of falls	24 months after intervention	To assess the number of falls in the intervention group and control group to determine if the intervention group has a significantly lower rate of falls.

Secondary Outcome Measures

Name	Time	Method
Euroqol-5D-5L	24 months after intervention	Evaluate the impact on the quality of life in people over 65 years of age who live in the community and who participate in this program
Number of falls that have been treated in hospital	24 months after intervention	Evaluate the number of falls that have been treated in hospital due to fractures or trauma resulting from falls

Trial Locations

Locations (1)

Gerencia de Atención Integrada de Talavera de la Reina; 🇪🇸 Talavera De La Reina, Toledo, Spain