Multifactorial Fall Prevention Program in People Aged 65 or Over of an Urban Area of Talavera de la Reina
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Number of falls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Group
Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).
干预措施: Physical exercise program (VIVIFRAIL) supervised by a physiotherapist (Behavioral)
Experimental Group
Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).
干预措施: Adequacy of the environment (Behavioral)
Experimental Group
Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).
干预措施: Polypharmacy review (Behavioral)
Experimental Group
Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).
干预措施: Health education related to falls prevention (4 sessions) (Behavioral)
Experimental Group
Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).
干预措施: General Assement (Behavioral)
Experimental Group
Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).
干预措施: Evaluation of patients by an expert group (Behavioral)
Experimental Group
Experimental group receive multifactorial intervention (based on the GBPC "Prevention of Falls and reduction of Injuries derived from falls" - RNAO).
干预措施: Information brochures on the importance of physical exercise (Behavioral)
Control Group
Control group receive activities on falls prevention by Primary Care professionals on a care routine.
干预措施: Information brochures on the importance of physical exercise (Behavioral)
Control Group
Control group receive activities on falls prevention by Primary Care professionals on a care routine.
干预措施: Physical exercise program (VIVIFRAIL) supervised by a primary care doctor or primary care nurse (Behavioral)
Control Group
Control group receive activities on falls prevention by Primary Care professionals on a care routine.
干预措施: Regular assessment and follow-up by primary care doctor and primary care nurse (Behavioral)
Control Group
Control group receive activities on falls prevention by Primary Care professionals on a care routine.
干预措施: Health education related to falls prevention (1 session) (Behavioral)
结局指标
主要结局
Number of falls
时间窗: 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.
次要结局
- Euroqol-5D-5L(24 months after intervention)
- Number of falls that have been treated in hospital(24 months after intervention)
