Multifactorial Fall Prevention Program (Dodgers)

Castilla-La Mancha Health Service

Status: Active, not recruiting

Conditions: Frail Elderly Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05682872

57/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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264 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).

Treatment:

Behavioral: Information brochures on the importance of physical exercise

Behavioral: Physical exercise program (VIVIFRAIL) supervised by a physiotherapist

Behavioral: Evaluation of patients by an expert group

Behavioral: Health education related to falls prevention (4 sessions)

Behavioral: Polypharmacy review

Behavioral: Adequacy of the environment

Behavioral: General Assement

Control Group

Active Comparator group

Description:

Control group receive activities on falls prevention by Primary Care professionals on a care routine.

Treatment:

Behavioral: Information brochures on the importance of physical exercise

Behavioral: Health education related to falls prevention (1 session)

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