Frail Elderly Syndrome
Conditions
Keywords
risk of falls, prevention, clinical trial
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.
Interventions
BEHAVIORALPhysical 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.
BEHAVIORALAdequacy 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.
BEHAVIORALPolypharmacy 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.
BEHAVIORALHealth 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)
BEHAVIORALGeneral Assement
General assessment (feet, footwear, nutrition, cognitive/psychological, social of risk factors) carried out by Primary Care Doctor and Primary Care Nurse
BEHAVIORALEvaluation 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.
BEHAVIORALInformation 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.
BEHAVIORALPhysical 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.
BEHAVIORALRegular 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.
BEHAVIORALHealth 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?
Sponsors
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.
Castilla-La Mancha Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of falls | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of falls that have been treated in hospital | 24 months after intervention | Evaluate the number of falls that have been treated in hospital due to fractures or trauma resulting from falls |
| Euroqol-5D-5L | 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 |
Countries
Spain
Outcome results
None listed