Multifactorial Fall Prevention Program

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Frail Elderly Syndrome

Intervention / Treatment
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* Behavioral: Physical exercise program (VIVIFRAIL) supervised by a physiotherapist
* Behavioral: Adequacy of the environment
* Behavioral: Polypharmacy review
* Behavioral: Health education related to falls prevention (4 sessions)
* Behavioral: General Assement
* Behavioral: Evaluation of patients by an expert group
* Behavioral: Information brochures on the importance of physical exercise
* Behavioral: Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nurse
* Behavioral: Regular assessment and follow-up by primary care doctor and primary care nurse
* Behavioral: Health education related to falls prevention (1 session)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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<br>* 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.<br>Behavioral: Adequacy of the environment<br>* A home study and the environment will be made to diagnose fall risks. Guided and supervised by a occupational therapist during a home visit.<br>Behavioral: Polypharmacy review<br>* Assessment of the medication that patients receives related to fall risks proposing its adjustment. Revised by a primary care doctor different from care routine.<br>Behavioral: Health education related to falls prevention (4 sessions)<br>* 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)<br>Behavioral: General Assement<br>* General assessment (feet, footwear, nutrition, cognitive/psychological, social of risk factors) carried out by Primary Care Doctor and Primary Care Nurse<br>Behavioral: Evaluation of patients by an expert group<br>* 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.<br>Behavioral: Information brochures on the importance of physical exercise<br>* 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.<br>|
| Active Comparator: Control Group<br>Control group receive activities on falls prevention by Primary Care professionals on a care routine. | Behavioral: Information brochures on the importance of physical exercise<br>* 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.<br>Behavioral: Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nurse<br>* 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.<br>Behavioral: Regular assessment and follow-up by primary care doctor and primary care nurse<br>* General assessment related to falls with the established protocols at primary care routine.<br>Behavioral: Health education related to falls prevention (1 session)<br>* 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?<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of falls | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk of falls, prevention, clinical trial