Multifactorial Fall Prevention Program

Frail Elderly Syndrome Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682872
• Other study ID #: 57/2020
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: March 9, 2025

Study information

• Verified date: February 2024
• Source: Castilla-La Mancha Health Service
• Contact: Nuria García Bonilla
• Phone: +34638225048
• Email: ngarciab[@]sescam.jccm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: March 9, 2025
• Est. primary completion date: March 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly Syndrome

Intervention

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.
• 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.
• 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.
• 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)
• General Assement
General assessment (feet, footwear, nutrition, cognitive/psychological, social of risk factors) carried out by Primary Care Doctor and Primary Care Nurse
• 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.
• 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.
• 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.
• 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.
• 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?

Locations

Country	Name	City	State
Spain	Gerencia de Atención Integrada de Talavera de la Reina	Talavera De La Reina	Toledo

Sponsors (6)

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

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Ambrose AF, Cruz L, Paul G. Falls and Fractures: A systematic approach to screening and prevention. Maturitas. 2015 Sep;82(1):85-93. doi: 10.1016/j.maturitas.2015.06.035. Epub 2015 Jun 26. — View Citation

Aranda-Gallardo M, Morales-Asencio JM, Canca-Sanchez JC, Toribio-Montero JC. Circumstances and causes of falls by patients at a Spanish acute care hospital. J Eval Clin Pract. 2014 Oct;20(5):631-7. doi: 10.1111/jep.12187. Epub 2014 Jun 5. — View Citation

Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3. — View Citation

Hopewell S, Adedire O, Copsey BJ, Boniface GJ, Sherrington C, Clemson L, Close JC, Lamb SE. Multifactorial and multiple component interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2018 Jul 23;7(7):CD012221. doi: 10.1002/14651858.CD012221.pub2. — View Citation

Izquierdo M, Casas-Herrero A, Zambm-Ferraresi F, Martínez-Velilla N, Alonso-Bouzón C, Rodríguez-Mañas L, et al. A Practical Guide for Prescribing a Multi-Component Physical Training Program to prevent weakness and falls in People over 70. 2017. http://www.vivifrail.com/resources.

Jutkowitz E, Gitlin LN, Pizzi LT, Lee E, Dennis MP. Cost effectiveness of a home-based intervention that helps functionally vulnerable older adults age in place at home. J Aging Res. 2012;2012:680265. doi: 10.1155/2012/680265. Epub 2011 Aug 16. — View Citation

Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11. — View Citation

Sepulveda-Loyola W, Rodriguez-Sanchez I, Perez-Rodriguez P, Ganz F, Torralba R, Oliveira DV, Rodriguez-Manas L. Impact of Social Isolation Due to COVID-19 on Health in Older People: Mental and Physical Effects and Recommendations. J Nutr Health Aging. 2020;24(9):938-947. doi: 10.1007/s12603-020-1469-2. — View Citation

Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4. — View Citation

Silva Gama ZA, Gomez Conesa A, Sobral Ferreira M. [Epidemiology of falls in the elderly in Spain: a systematic review, 2007]. Rev Esp Salud Publica. 2008 Jan-Feb;82(1):43-55. doi: 10.1590/s1135-57272008000100004. Spanish. — View Citation

Viana TS, Martin MR, Crespo FN, Rodriguez EM, Merino GM, Ruiz JM, Lorenzo IL, Quintas CG. [What is the real incidence of falls in hospitals?]. Enferm Clin. 2011 Sep-Oct;21(5):271-4. doi: 10.1016/j.enfcli.2011.02.011. Epub 2011 Jun 30. Spanish. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   A CDC Compendium of Effective Fall Interventions: What Works for Community-Dwelling Older Adults
•   World Health Organization. falls. Fact Sheet no 344.