FallsNCT00247546
Prevention of Falls and Injurious Falls Among Elderly People
A study testing Multifactorial prevention in people with Falls and Accidental Falls, run by The Hospital District of Satakunta at 1 site in Finland.
Trial summary
The aim of this study is to describe and analyse the effects of multifactorial trial on the incidence of falls and injurious falls and on different risk factors of falling among the home-dwelling aged. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Falls, Accidental Falls
- What is being tested?
- Multifactorial prevention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 592 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2003to Mar 2005
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age or older
- home-dweller
- having fallen at least once during the previous 12 months
- at least moderate cognitive abilities (MMSE over 17)
- able to walk 10 metres independently
Who cannot join
- MMSE under 17
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to describe and analyse the effects of multifactorial trial on the incidence of falls and injurious falls and on different risk factors of falling among the home-dwelling aged.
Read the detailed description
The aims of the study:
- To implement a program for the prevention of falls and injurious falls.
- To describe the structure and activities of the fall prevention program implemented among the aged who are living in their own home, have at least moderate cognitive abilities, have fallen during previous 12 months and are 65 years of age or older. A further aim is to describe the frequency of participation according to age, gender, residence, health and physical condition.
- To describe the effects of prevention on primary risk factors of falling such as muscle strength, balance, eye sight, medications, depression and home hazards in relation to age, gender, health and physical condition.
- To describe and assess the effects of prevention on the incidence of falls and injurious falls.
- To assess the effects of prevention on physical, cognitive and psychosocial functional abilities, quality of life and use of health and social services and deaths.
- Conditions
- Falls, Accidental Falls
- Being tested
- Multifactorial prevention
- Keywords
- Falls, Accidental falls, Prevention, Aged, Multifactorial trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial preventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of falls and injurious falls
Secondary outcomes (5)
Risk factors of falling
Functional abilities
Quality of life
Use of health and social services
Deaths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startMar 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 592 participants
Sponsor and investigators
- Lead sponsor
- The Hospital District of Satakunta
- Sponsor type
- University, hospital or other
- Investigators
- Sirkka-Liisa Kivelä, Professor, Study director, The Hospital District of Satakunta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247546
- Sponsor's protocol ID
- 02032002
- Status last verified
- Sep 2006
- First submitted
- 1 Nov 2005
- Last updated
- 18 Oct 2006
- Results posted
- No
Publications
Salminen M, Vahlberg T, Kivela SL. The long-term effect of a multifactorial fall prevention programme on the incidence of falls requiring medical treatment. Public Health. 2009 Dec;123(12):809-13. doi: 10.1016/j.puhe.2009.10.018.
PubMed 19958918
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Falls and Injurious Falls Among Elderly People
- ClinicalTrials.gov ID
- NCT00247546
- Acronym / sponsor ID
- 02032002
- Conditions
- Falls, Accidental Falls
- Keywords
- Falls, Accidental falls, Prevention, Aged, Multifactorial trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants
- Lead sponsor
- The Hospital District of SatakuntaUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Mar 2005
- First posted
- 2 Nov 2005 (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.
The aim of this study is to describe and analyse the effects of multifactorial trial on the incidence of falls and injurious falls and on different risk factors of falling among the home-dwelling aged.
Detailed description
The aims of the study:
- To implement a program for the prevention of falls and injurious falls.
- To describe the structure and activities of the fall prevention program implemented among the aged who are living in their own home, have at least moderate cognitive abilities, have fallen during previous 12 months and are 65 years of age or older. A further aim is to describe the frequency of participation according to age, gender, residence, health and physical condition.
- To describe the effects of prevention on primary risk factors of falling such as muscle strength, balance, eye sight, medications, depression and home hazards in relation to age, gender, health and physical condition.
- To describe and assess the effects of prevention on the incidence of falls and injurious falls.
- To assess the effects of prevention on physical, cognitive and psychosocial functional abilities, quality of life and use of health and social services and deaths.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years of age or older
- home-dweller
- having fallen at least once during the previous 12 months
- at least moderate cognitive abilities (MMSE over 17)
- able to walk 10 metres independently
Key exclusion criteria (1 listed)
- MMSE under 17
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 |
|---|---|---|
| Multifactorial prevention | Behavioural | – |
Primary outcome
Incidence of falls and injurious falls
5 secondary outcomes
Risk factors of falling
Functional abilities
Quality of life
Use of health and social services
Deaths
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 18 Oct 2006.
- Derived from this study: PubMed 19958918Salminen M, Vahlberg T, Kivela SL. The long-term effect of a multifactorial fall prevention programme on the incidence of falls requiring medical treatment. Public Health. 2009 Dec;123(12):809-13. doi: 10.1016/j.puhe.2009.10.018.
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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.
Sirkka-Liisa Kivelä, Professor study director
The Hospital District of Satakunta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial prevention in people with Falls and Accidental Falls, run by The Hospital District of Satakunta at 1 site in Finland.
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 5 inclusion and 1 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 18 Oct 2006. 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 Finland. 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?
Incidence of falls and injurious falls. 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 NCT00247546, which also lists 1 linked publication.
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 18 Oct 2006.