Falling Prevention Comprehensive Model for Older People Self-caring

NCT04313062 | Completed

• 1 other identifier: ID19I10349
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Fall; Accident at Home

Keywords

Aged; Accident Prevention; House Calls; Clinical Trial

Outcome Measures

Primary Outcomes (3)

• Fall frequency

  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).

  T2 (1 year, final house call)

• Management of external and internal falls risk factors

  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.

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

• Perception on falls risk factors

  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.

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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Educational Intervention

Standard care

NO INTERVENTION

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 ".

Interventions

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 " .

Also known as: PM ACTIVAS' intervention model

Intervention

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Corporación Municipal de Renca, Chile: collaborator
• RH Atlantis Healthtech Solutions SPA: collaborator

Study Sites (1)

Corporación Municipal de Renca

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (2)

• Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  PMID: 39360568 DERIVED

• Marquez-Doren F, Lucchini-Raies C, Alcayaga C, Bustamante C, Gonzalez-Aguero M. Acceptability and feasibility of a comprehensive fall prevention model for independent older adults: A qualitative evaluation. Int J Nurs Stud Adv. 2024 Jun 22;7:100220. doi: 10.1016/j.ijnsa.2024.100220. eCollection 2024 Dec.

  PMID: 39050690 DERIVED

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Claudia Bustamante-Troncoso, MNSc RN

  Profesor Asociado Escuela de Enfermería Pontificia Universidad Católica de Chile

  PRINCIPAL INVESTIGATOR

• Francisca Márquez-Doren, PhD MNSc RN

  Profesor Asociado Escuela de Enfermería Pontificia Universidad Católica de Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: January 7, 2021
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

CL (1)