Effect on Falls Reduction of a Multimodal Intervention in Frail and Pre-frail Elderly Community-dwelling People

Accidental Falls Clinical Trial

— FAREMAVA  

Official title:

Effect on Falls Reduction of a Multimodal Intervention in Frail and Pre-frail Elderly Community-dwelling People in Madeira Island (Portugal) and Valencia (Spain)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02631330
• Other study ID #: FAREMAVA2015
• Status: Recruiting
• Phase: Phase 3
• First received: December 3, 2015
• Last updated: December 12, 2015
• Start date: December 2015
• Est. completion date: July 2017

Study information

• Verified date: December 2015
• Source: Hospital de la Ribera
• Contact: Francisco J Tarazona-Santabalbina, MD,PhD
• Phone: 962458100
• Email: fjtarazona[@]hospital-ribera.com
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Practice guidelines in caring for the geriatric population recommend performing an annual screening of falls . However, one of the problems that interfere with fall prevention programs is the lack of importance accorded to health professionals to falls. This lack of awareness of the risks faced by the associated geriatric population falls generates reluctance to adherence to a fall prevention program . At European level there are the same gaps in knowledge about the real effectiveness and efficiency of fall prevention programs .

HYPOTHESIS: The implementation of a multicomponent fall prevention program in frail and pre-frail elderly community-dwelling people reduce the incidence of falls.

OBJECTIVES

General:

• To determine the efficacy of a comprehensive program to prevent falls in the community.

Specific:

• Knowing whether reducing the incidence of falls implies a reduction in visits to primary care, emergency department or hospital staying.

• Knowing the adhesion, through indirect measures, to the intervention program.

• Knowing the nutritional, functional, cognitive, social, anthropometric, respiratory and clinical profile, including falls, of the sample.

MATERIAL AND METHODS

Study design:

Multicenter community intervention study, longitudinal, prospective, randomized, and experimental.

Through intervention by nurses in primary care education of subjects over 70 years it is to know the effectiveness of a comprehensive program of falls prevention.

It will proceed to recruit older than or equal to 70 years subjects, who meet frailty criteria age, belonging to the areas of Madeira Island (Portugal) and La Ribera County (Valéncia, Spain) .

Description:

INTRODUCTION The World Health Organization (WHO) defines fall as a result of any event precipitating the patient down, involuntarily .

Along with instability and gait disturbances, falls are one of the great geriatric syndromes and are the second cause of death worldwide by unintentional injuries.

In the field of public health, falls in the elderly are considered a major biopsychosocial problem due to medical, psychological, social and family and economic consequences. It is estimated that in 2020 the cost generated to the social and health care by falls will be about 30,000 million euros. This is because about 20% of falls require medical attention, with approximately 10% of consultations in emergency services and 6% of urgent hospitalization in the elderly .

Mortality in elderly people as a result of falls is nearly 40,000 deaths annually in Europe, obtaining in Spain a mortality rate 15 . It also has a high morbidity, as declines are directly related to decreased mobility and ability to perform basic activities of daily living, raising fears of a new fall and thus favoring the loss of one's safety same. Thus the dependence on a caregiver or institutionalization in a home increases, in turn, the family, social and economic impact.

Falls in the elderly, unlike the adult, are the result of the adaptive imbalance of the person from the environment. The clinician relativizes this problem by attributing the fall to the normal aging process and ignore its potential consequences: injury, disability, institutionalization and even death in this population. For this reason, falls are considered a factor of frailty in the elderly .

The performance of health workers to a fall in the elderly patient should consist of the realization of the following measures :

• Conduct a comprehensive assessment of elderly: biomedical, functional, social, mental and psycho-sphere.

• Identify intrinsic, extrinsic risk factors and circumstances of the fall.

• Estimate early physical, psychological and socio-economic consequences.

• Prevention of falls at primary, secondary and tertiary levels. Frailty is a pathophysiological syndrome characterized by decreased functional reserve which is mainly linked to the loss of muscle mass or sarcopenia. This is caused by the decline in physical activity, associated in turn with poor health habits, cardiovascular risk factors and various chronic diseases. The consequences in the elderly affect multiple systems , causing greater vulnerability to external agents and increasing the risk: disability, hospitalization, institutionalization and death . The prevalence of frailty in subjects over 65 years is between 7 and 16.3% , increasing every decade from this age .

The diagnostic criteria for fragility, described by Linda Fried, include the assessment of functional aspects as the gait assessment, exhaustion or strength of palmar pressure with weight loss and energy consumption associated with physical activity . Since therapeutic perspective, one of the best ways to reverse the frailty is the physical exercise. Several articles have described heterogeneous effects on physical interventions in elderly frailty people , ranging from isolated programs of aerobic, anaerobic or balance to different combinations of the same training. A multicomponent exercise program increased muscle strength, improve cardiorespiratory fitness and balance11. Exercise programs have observed improvement in symptoms of depression in elderly patients10 up to 3 months after completion of the program . This benefit may be due to increased central monoamine activity and increased secretion of beta-endorphin. Similarly, it has been linked exercise programs with improvement in various cognitive domains, especially in executive functions. A 2003 meta-analysis indicates that the combined program of aerobic and anaerobic exercise have a better outcome on cognitive status than those designed with only aerobic programs.

STUDY JUSTIFICATION Nearly six million Spanish people are older than 70 years, 12.64% of the Spanish population is elderly. The first study in Spain on falls in the elderly was conducted in 1985 and from then until now, it has encouraged the investigation.

Practice guidelines in caring for the geriatric population recommend performing an annual screening of falls . Moreover, they suggest to advice the elderly on possible risk factors associated. However, one of the problems that interfere with fall prevention programs is the lack of importance accorded to health professionals to falls. This lack of awareness of the risks faced by the associated geriatric population falls generates reluctance to adherence to a fall prevention program .

At European level there are the same gaps in knowledge about the real effectiveness and efficiency of fall prevention programs .

Add the practice of physical activity in nursing interventions, under the environment of the community, have shown a reduction in the use of emergency services at relatively short intervals, probably due to improved continuity of care .

The Hunter study showed that a training program low-level resistance (twice a week) is associated with a decrease in the progression of functional limitations within 6 months.

Physical activity associated with an interdisciplinary approach improves overall assessment of the frail elderly population on the functional, psychological, cognitive, clinical and social part , , , .

It is necessary to create an interdisciplinary team in daily clinical practice in frail patients to perform adequately the full recognition of these patients with the following characteristics:

• Shared management between nursing and primary care.

• Support staff (nurses, social workers) with specialized training in gerontology.

• Audit of the home and technical devices needs.

• Regular team meetings to evaluate changes.

• Establishment of communication with community resources to incremental improvements in the home, health promotion and support to caregivers.

HYPOTHESIS The implementation of a multicomponent fall prevention program in frail and pre-frail elderly community-dwelling people reduce the incidence of falls.

OBJECTIVES

General:

• To determine the efficacy of a comprehensive program to prevent falls in the community.

Specific:

• Knowing whether reducing the incidence of falls implies a reduction in visits to primary care, emergency department or hospital staying.

• Knowing the adhesion, through indirect measures, to the intervention program.

• Knowing the nutritional, functional, cognitive, social, anthropometric, respiratory and clinical profile, including falls, of the sample.

MATERIAL AND METHODS

Study design:

Multicenter community intervention study, longitudinal, prospective, randomized, and experimental.

Through intervention by nurses in primary care education of subjects over 70 years it is to know the effectiveness of a comprehensive program of falls prevention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 466
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Women and men with older than or equal to 70 years old.

• Independent ambulation (may have technical aids but not someone else).

• Usual residence in the areas of health described.

• Linda Fried's Criteria of pre-frailty or frailty.

Exclusion Criteria:

• Patients with life expectancy of less than six months.

• Institutionalized patients.

• Patients with severe hearing or visual deficits.

• Patients with contraindication in physical exercise.

• Patients with serious psychiatric illness or moderate or severe cognitive impairment.

• Patients who refuse to sign the informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Other:
• Multicomponent physical activity
Balance, muscle strength and aerobic capacity will be increased in intensity according Training Intervention in a Controlled Population of Frail Elderly (EMTIFE) study NCT02331459

Locations

Country	Name	City	State
Spain	Hospital Universitario de la Ribera	Alzira	Valéncia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de la Ribera

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Cadore EL, Rodríguez-Mañas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397. Review. — View Citation

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. — View Citation

Porter Starr KN, McDonald SR, Bales CW. Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials. J Am Med Dir Assoc. 2014 Apr;15(4):240-50. doi: 10.1016/j.jamda.2013.11.008. Epub 2014 Jan 17. Review. — View Citation

Theou O, Stathokostas L, Roland KP, Jakobi JM, Patterson C, Vandervoort AA, Jones GR. The effectiveness of exercise interventions for the management of frailty: a systematic review. J Aging Res. 2011 Apr 4;2011:569194. doi: 10.4061/2011/569194. — View Citation

Vivrette RL, Rubenstein LZ, Martin JL, Josephson KR, Kramer BJ. Development of a fall-risk self-assessment for community-dwelling seniors. J Aging Phys Act. 2011 Jan;19(1):16-29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls incidence change	Number of falls observed during the follow up period	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Primary care and emergency department visits related with falls	Number of visits related with falls observed during the follow up period in primary attention services, emergency departments and hospital admissions	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Changes in nutritional status	Change in nutritional parameters (MNA score) between groups during follow up period	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Changes in functional status	Changes in the following variable during follow up period: SHORT PHYSICAL PERFORMANCE BATTERY,	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Changes in cognitive status	Changes in the following variable during follow up period: MMSE	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Changes in anthropometric measures	Changes in the following variable during follow up period: BMI	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Changes in respiratory function	Changes in the following variables during follow up period; : FVC, FEV1, FEV1/FVC, MEF25/75, FEV25, FEV50, FEV75, PEF, MIP (Maximal inspiratory pressure) (ELKA-PM15)®, MEP (Maximal espiratory pressure) (ELKA-PM15)®	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Changes in daily living autonomy	Changes in the following variables during follow up period; : BARTHEL SCALE LAWTON SCALE	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Changes in quality of life	Changes in the following variables during follow up period; :EUROQOL-5D	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Changes in mood state	Changes in the following variable during follow up period; :Yesavage Geriatric Depression Scale.	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes
Secondary	Changes in clinical aspects	Changes in the following variable during follow up period; : Hospital admissions rate related with falls	day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)	Yes