FallsNCT00804492
Establishment of an Integrated Model for Prevention of Elderly Falls
A study testing Multifaceted intervention in people with Falls, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Falls, with a high prevalence, high risk and consequent medical and social costs, are an important issue for medical care and health promotion in the elderly. The prevalence of falls in the elderly lies in between 10-20%. Falls have become the second leading cause of death from injury for the elderly in Taiwan. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls
- What is being tested?
- Multifaceted intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to Dec 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Old people (65 years old or more)
- With at least one fall in the past one year, or with disease related to fall, such as central nerve system disease or lower extrimity fracture
Who cannot join
- The result of screening test is "no fall risk"
- Cannot be followed for 6 months
- Cannot be evaluated because of the mental status
- Cannot have the exercise intervention
- Falling due to expected reason, such as suffering heart atteck
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bureau of Health Promotion,Department of Health, R.O.C. (Taiwan)
Falls, with a high prevalence, high risk and consequent medical and social costs, are an important issue for medical care and health promotion in the elderly. The prevalence of falls in the elderly lies in between 10-20%. Falls have become the second leading cause of death from injury for the elderly in Taiwan. A community-based study showed that, among those old adults after a fall, 27.3% were severely injured, 53.9% got a minor injury, and only 18.9% remained intact. Another study revealed that among fall injury events reported, 42% were hospitalized, of whom 2.2% died in hospital, and 37% entered nursing homes after discharge from hospital. In addition to physical discomfort, half of the elderly fallers would become disabled, and bring a heavy burden of social economy and family care. It was estimated that there were 460 thousand of old people who had a fall, and 125 thousand of them were injured in Taiwan, 2007. Research evidence shows that falls prevention is effective and feasible. Although primary falls prevention programs have been conducted at the community level and extended to 25 counties and cities for many years, they were not integrated with secondary and tertiary prevention. The study aims to establish an integrated fall prevention model, combined with primary, secondary and tertiary prevention. The model will be practiced in participating hospitals and communities, with a randomized control trial (RCT) design to examine its feasibility and effectiveness. Our study subjects are persons aged 65 and over who live in communities, go to out-patient departments (OPD) or emergency room (ER) care.
Tasks for implementation
- To organize a multidisciplinary team for integrated falls prevention.
- To draft a guideline for falls prevention in the elderly.
- To set up a multidisciplinary fall clinic.
- To set up a falls prevention classroom.
- To enhance cooperate between hospitals and primary care units to fulfill the guideline for falls prevention in the elderly.
- Conditions
- Falls
- Being tested
- Multifaceted intervention
- Keywords
- To organize a multidisciplinary team for integrated falls prevention, To draft a guideline for falls prevention in the elderly, To set up a multidisciplinary fall clinic, To set up a falls prevention classroom, To enhance cooperate between hospitals and primary care units for falls prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted interventionBehavioural
consulted, educated, referred or receive an exercise training for their fitness, strength and balance
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | To establish an integrated intervention model for prevention of elderly fall Receives: Behavioral: Multifaceted intervention |
| 2 | Experimental | To perform a RCT to investigate the effectiveness of the multicenter, multifaceted intervention program Receives: Behavioral: Multifaceted intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of fall
Measured: once per month for 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jau-Yih Tsauo, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804492
- Sponsor's protocol ID
- 200710010R
- Status last verified
- Jun 2010
- First submitted
- 4 Dec 2008
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bureau of Health Promotion,Department of Health, R.O.C. (Taiwan)
- ClinicalTrials.gov ID
- NCT00804492
- Acronym / sponsor ID
- 200710010R
- Conditions
- Falls
- Keywords
- To organize a multidisciplinary team for integrated falls prevention, To draft a guideline for falls prevention in the elderly, To set up a multidisciplinary fall clinic, To set up a falls prevention classroom, To enhance cooperate between hospitals and primary care units for falls prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Dec 2008 (estimated)
- 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, with a high prevalence, high risk and consequent medical and social costs, are an important issue for medical care and health promotion in the elderly. The prevalence of falls in the elderly lies in between 10-20%. Falls have become the second leading cause of death from injury for the elderly in Taiwan. A community-based study showed that, among those old adults after a fall, 27.3% were severely injured, 53.9% got a minor injury, and only 18.9% remained intact. Another study revealed that among fall injury events reported, 42% were hospitalized, of whom 2.2% died in hospital, and 37% entered nursing homes after discharge from hospital. In addition to physical discomfort, half of the elderly fallers would become disabled, and bring a heavy burden of social economy and family care. It was estimated that there were 460 thousand of old people who had a fall, and 125 thousand of them were injured in Taiwan, 2007. Research evidence shows that falls prevention is effective and feasible. Although primary falls prevention programs have been conducted at the community level and extended to 25 counties and cities for many years, they were not integrated with secondary and tertiary prevention. The study aims to establish an integrated fall prevention model, combined with primary, secondary and tertiary prevention. The model will be practiced in participating hospitals and communities, with a randomized control trial (RCT) design to examine its feasibility and effectiveness. Our study subjects are persons aged 65 and over who live in communities, go to out-patient departments (OPD) or emergency room (ER) care.
Tasks for implementation
- To organize a multidisciplinary team for integrated falls prevention.
- To draft a guideline for falls prevention in the elderly.
- To set up a multidisciplinary fall clinic.
- To set up a falls prevention classroom.
- To enhance cooperate between hospitals and primary care units to fulfill the guideline for falls prevention in the elderly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Multifaceted interventionTo establish an integrated intervention model for prevention of elderly fall |
| 2 | Experimental | Behavioral: Multifaceted interventionTo perform a RCT to investigate the effectiveness of the multicenter, multifaceted intervention program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Old people (65 years old or more)
- With at least one fall in the past one year, or with disease related to fall, such as central nerve system disease or lower extrimity fracture
Key exclusion criteria (5 listed)
- The result of screening test is "no fall risk"
- Cannot be followed for 6 months
- Cannot be evaluated because of the mental status
- Cannot have the exercise intervention
- Falling due to expected reason, such as suffering heart atteck
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 |
|---|---|---|
| Multifaceted interventionconsulted, educated, referred or receive an exercise training for their fitness, strength and balance | Behavioural | 1, 2 |
Primary outcome
The number and severity of fall
Time frame: once per month for 6 monthes
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 29 Jun 2010.
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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.
Jau-Yih Tsauo principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted intervention in people with Falls, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 5 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 29 Jun 2010. 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 Taiwan. 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?
The number and severity of fall (time frame: once per month for 6 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2010; AzTrials last refreshed its copy on 7 Nov 2026.