Falling Prevention Comprehensive Model for Older People Self-caring (PMACTIVAS)

Pontificia Universidad Catolica de Chile

Status: Completed

Conditions: Accidental Fall; Accident at Home

Treatments: Behavioral: Educational Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04313062

ID19I10349

Details and patient eligibility

About

Falls in elderly people are a public health problem and in Chile there's a deficit regarding prevention strategies focused on high functioning older people who live in the community. The aim of the study is to design, implement and evaluate a comprehensive model based on house calls and oriented towards falling prevention (PM ACTIVAS' model). The researchers will perform a clinical trial in a district of Santiago, Chile to evaluate this model. Our hypothesis are that people who received the educational intervention following the PM ACTIVAS' model will: fall less frequently, improve their management on falls risk factors present at home, and have a higher falls risk perception than the control group. The researchers also expect that it will be possible to establish cut off points in a valid and reliable scale to assess the presence of falls risk factors in elderly people.

Full description

The comprehensive model PM ACTIVAS uses the house call to make a multidimensional assessment on the patient's falls risks factors (internal and external) and their falls risk perception in order to come up with a plan (together with the patient and their family, if present) to modify the hazards present at the patient's home. Together with a telephone follow-up to support the patient in their plan, it is expected that the patient would have a higher falls risk perception, lower falls risks present at home in order to prevent falling.

In the clinical trial, the sample will comprise of 220 high-functioning elderly people (from 65 to 80 years old) from the area which will be divided in two groups. The intervention group will receive a house call to perform the educational intervention with the PM ACTIVAS' model, while the control group will receive standard care from their health center. The research team will measure their internal and external falls risk factors and their falls risk perception at the beginning and at the end of the study. They will also receive a "Falling Prevention Kit" and a "Fall and Events Calendar" where they have to write every time they fall or trip and the day when it happened. At the end of the study, both groups will receive a house call to measure again their falls risk factors and perceptions in order to analyze if there has been any difference between groups regarding these factors.

Enrollment: 220 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Older people who has 43 points or more in the elderly functionality test [Examen de Funcionalidad del Adulto Mayor: EFAM] part A test (a chilean validated test that assesses functionality) at recruitment.

Exclusion criteria

• Older people whose address does not belong to the health center's territory.
• Older people who have any visual or hearing impairment that hinders effective communication
• Older people with depression or any mild to severe mood disorder stated in their health physical record booklet or drug registry booklet.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention group will receive the PM ACTIVAS' intervention model. This intervention will be done by a member of the technical staff (previously trained) at the patient's home (house call). In the house call, the trainee will perform a multidimensional assessment of the patient's falling risks factor (internal and external), deliver a " Falling Prevention Kit " and lastly establish together (with the patient and their family) a plan to change the hazards in their home. The patients will receive a telephone follow-up by the same technical staff member until the final house call, which will be 12 months after the recruiting. Finally, 12 months after recruitment, they will receive a last house call where the trainee will assess with the patient and the family the plan, ask for the " Falls and Events Calendar " given at recruitment (where the older person and/or their family registered every trip or fall during the 12-month period), and conduct the final survey.

Treatment:

Behavioral: Educational Intervention

Standard care

No Intervention group

Description:

The control group will receive the standard care from the community health center. They will not receive a telephone follow-up. They will receive a house call 12 months after recruitment by a trainee, who will conduct the final survey and ask for the " Falls and Events Calendar " given at recruitment (where the older person and/or their family registered every trip or fall during the 12-month period). Lastly, they will receive an abbreviated intervention for falling prevention and be given the " Falling Prevention Kit ".