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Completed

NCT Number: NCT04313062

Falling Prevention Comprehensive Model for Older People Self-caring

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.

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Key information

Conditions

Accidental Fall Accident at Home

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporación Municipal de Renca

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational intervention

Behavioral

An educational intervention based on the PM ACTIVAS' model and a " Falling Prevention Kit ", both in a home visit by the trainees. Also, a telephone follow-up and a last house call 12 months after recruiting to assess the changes implemented by the person and their family, to conduct the final survey and to ask for the " Falls and Events Calendar " .

Other names: PM ACTIVAS' intervention model

Primary outcomes

  1. Fall frequency

    Time frame: T2 (1 year, final house call)

    Number of falls registered on the " Falls and Events Calendar " in both the control and the intervention group. This calendar is a typical calendar where the patient and/or family have to write the days that the patient fell or tripped. The calendar was given to the patients at recruitment (T0) and have been taught how to register the falls, trips and related events in both groups. The research team will collect the data on the last house call (T2).

  2. Management of external and internal falls risk factors

    Time frame: T0 (recruitment) and T2 (1 year, final house call)

    The research team will measure this with a previously validated checklist, which consists of 41 questions where the patient has to reply yes or no. The questions are related to internal and external falls risk factors. This survey will be applied at the recruitment (T0) and in the last house call (T2) in both control and intervention groups.

  3. Perception on falls risk factors

    Time frame: T0 (recruitment) and T2 (1 year, final house call)

    The researchers will measure the perception that the patient has on falls risk factors in the home setting with a set of drawings where the patient has to identify what they consider as a falls risk factor. The research team will apply this at the recruitment (T0) and in the last house call (T2) in both control and intervention groups.

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • Corporación Municipal de Renca, Chile
  • RH Atlantis Healthtech Solutions SPA

Registry information

Official study title

Older People Self-caring Through a Comprehensive Model Based on House Calls and Oriented Towards Falling Prevention (PM ACTIVAS)

Acronym: PMACTIVAS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2020
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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