Clinical trial NCT04313062: Falling Prevention Comprehensive Model for Older People Self-caring
Official title: Older People Self-caring Through a Comprehensive Model Based on House Calls and Oriented Towards Falling Prevention (PM ACTIVAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Fall
Accident at Home
Keywords: Aged
Accident Prevention
House Calls
Clinical Trial
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Corporación Municipal de Renca, Chile
name: RH Atlantis Healthtech Solutions SPA
First posted: 2020-03-18
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fall frequency
timeFrame: T2 (1 year, final house call)
measure: Management of external and internal falls risk factors
timeFrame: T0 (recruitment) and T2 (1 year, final house call)
measure: Perception on falls risk factors
timeFrame: T0 (recruitment) and T2 (1 year, final house call)
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Corporación Municipal de Renca
state: Región Metropolitana
Study officials:
affiliation: Profesor Asociado Escuela de Enfermería Pontificia Universidad Católica de Chile
name: Claudia Bustamante-Troncoso, MNSc RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Profesor Asociado Escuela de Enfermería Pontificia Universidad Católica de Chile
name: Francisca Márquez-Doren, PhD MNSc RN
role: STUDY_DIRECTOR
References: