Accidental FallPMACTIVASNCT04313062
Falling Prevention Comprehensive Model for Older People Self-caring
A study testing Educational Intervention in people with Accidental Fall and Accident at Home, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall, Accident at Home
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChile
- Study dates
- 7 Jan 2021to 11 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Older People Self-caring Through a Comprehensive Model Based on House Calls and Oriented Towards Falling Prevention (PM ACTIVAS)
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.
Read the 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.
- Conditions
- Accidental Fall, Accident at Home
- Being tested
- Educational Intervention
- Keywords
- Aged, Accident Prevention, House Calls, Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
Also called PM ACTIVAS' intervention model
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 " .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 ". |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: T0 (recruitment) and T2 (1 year, final house call)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start7 Jan 2021
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Corporación Municipal de Renca, Chile, RH Atlantis Healthtech Solutions SPA
- Responsible party
- Sponsor
- Investigators
- Claudia Bustamante-Troncoso, MNSc RN, Principal investigator, Profesor Asociado Escuela de Enfermería Pontificia Universidad Católica de ChileFrancisca Márquez-Doren, PhD MNSc RN, Study director, Profesor Asociado Escuela de Enfermería Pontificia Universidad Católica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313062
- Sponsor's protocol ID
- ID19I10349
- Acronym
- PMACTIVAS
- Status last verified
- Apr 2022
- First submitted
- 16 Mar 2020
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39360568Marquez-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.
PubMed 39050690
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Older People Self-caring Through a Comprehensive Model Based on House Calls and Oriented Towards Falling Prevention (PM ACTIVAS)
- ClinicalTrials.gov ID
- NCT04313062
- Acronym / sponsor ID
- PMACTIVAS / ID19I10349
- Conditions
- Accidental Fall, Accident at Home
- Keywords
- Aged, Accident Prevention, House Calls, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Corporación Municipal de Renca, Chile, RH Atlantis Healthtech Solutions SPA
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Educational InterventionThe 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. |
| 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 ". |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: PM ACTIVAS' intervention modelAn 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 " . | Behavioural | Intervention |
Primary outcome
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 39360568Drahota 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.
- Derived from this study: PubMed 39050690Marquez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Bustamante-Troncoso, MNSc RN principal investigator
Profesor Asociado Escuela de Enfermería Pontificia Universidad Católica de Chile
Francisca Márquez-Doren, PhD MNSc RN study director
Profesor Asociado Escuela de Enfermería Pontificia Universidad Católica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Accidental Fall and Accident at Home, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall frequency (time frame: T2 (1 year, final house call)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.