Effect on Falls Reduction of a Multimodal Intervention in Frail and Pre-frail Elderly Community-dwelling People in Madeira Island (Portugal) and Valencia (Spain)
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 466
- Locations
- 2
- Primary Endpoint
- Falls incidence change
Study Overview
Brief 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) .
Detailed 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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Falls incidence change
Time Frame: day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days)
Number of falls observed during the follow up period
Secondary Outcomes
- Changes in functional status(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
- Changes in anthropometric measures(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
- Changes in quality of life(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
- Changes in daily living autonomy(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
- Changes in nutritional status(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
- Changes in respiratory function(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
- Changes in mood state(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
- Primary care and emergency department visits related with falls(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
- Changes in cognitive status(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
- Changes in clinical aspects(day 0, day 90, day 180, day 270 and day 365 (plus or minus 5 days))
Investigators
Francisco Jose Tarazona-Santabalbina
MD, PhD, Consultant in Geriatric Medicine Hospital Universitario de la Ribera. Associated Professor Universidad Católica de Valencia San Vicente Mártir
Hospital de la Ribera