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Clinical Trials/NCT05682872
NCT05682872
Active, Not Recruiting
N/A

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

Castilla-La Mancha Health Service1 site in 1 country264 target enrollmentMarch 9, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frail Elderly Syndrome
Sponsor
Castilla-La Mancha Health Service
Enrollment
264
Locations
1
Primary Endpoint
Number of falls
Status
Active, Not Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2021
End Date
November 9, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Castilla-La Mancha Health Service
Responsible Party
Sponsor

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Number of falls

Time Frame: 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 Outcomes

  • Euroqol-5D-5L(24 months after intervention)
  • Number of falls that have been treated in hospital(24 months after intervention)

Study Sites (1)

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