Multifactorial Fall Prevention Program (Dodgers)

February 13, 2024 updated by: Castilla-La Mancha Health Service

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Toledo
      • Talavera De La Reina, Toledo, Spain, 45600
        • Recruiting
        • Gerencia de Atención Integrada de Talavera de la Reina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).
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.
Active Comparator: Control Group
Control group receive activities on falls prevention by Primary Care professionals on a care routine.
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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of falls that have been treated in hospital
Time Frame: 24 months after intervention
Evaluate the number of falls that have been treated in hospital due to fractures or trauma resulting from falls
24 months after intervention
Euroqol-5D-5L
Time Frame: 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
24 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Collaborators

Colegio Oficial de Terapeutas Ocupacionales de Castilla - La Mancha
Fundación Eurocaja Rural
Fundación Hestia
Unidad de Apoyo a la Investigación de la Gerencia de Atención Integrada de Talavera de la Reina
Decathlon España S.A.U.

Investigators

  • Principal Investigator: Nuria García Bonilla, Gerencia de Atención Integrada de Talavera de la Reina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Estimated)

March 9, 2025

Study Completion (Estimated)

March 9, 2025

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 57/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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