Accidental FallsNCT00226486
Examination and Treatment of Elderly After a Fall
A study testing multifactorial intervention in people with Accidental Falls, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Falls and injurious falls are common among elderly people. The aim of the study is to test a model of multifactorial fall intervention in a Danish population of elderly sustaining a fall. Focus is on prevention of further falls, patients views on fall prevention and a cost-effectiveness analysis. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- multifactorial intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 392 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2005to Mar 2008
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old or older
- Having been treated in emergency department or submitted to hospital after a fall
- Living in the Glostrup area.
Who cannot join
- Fall due to strong external force, new apoplexia cerebri, epileptic seizure, alcohol intoxication.
- Known cognitive impairment
- Not able to walk prior to fall
- Living in institution
- Planned geriatric intervention.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Geriatrics, Amtssygehuset i Glostrup
Glostrup Municipality, 2600
About this study
Official title: Examination and Treatment of Elderly After a Fall- an Analysis in a Medical Technology Evaluation Perspective
Falls and injurious falls are common among elderly people. The aim of the study is to test a model of multifactorial fall intervention in a Danish population of elderly sustaining a fall. Focus is on prevention of further falls, patients views on fall prevention and a cost-effectiveness analysis.
- Conditions
- Accidental Falls
- Being tested
- multifactorial intervention, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifactorial interventionOther
Identification of medical, cardiovascular, physical risk factors for falls; e.g. vision, drug-use, depression, carotid sinus syndrome, orthostatic hypotension, etc. Individual intervention; treatment of disease, drug review, pacemaker, exercises, new glasses, all if indicated.
Usual careOther
No intervention, but ususal care after an accidental fall.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Identification of individual risk factors for falls and specified intervention aimed diminishing these risk factors in the individual. Receives: Other: multifactorial intervention |
| 2 | Placebo comparator | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls and injurious falls in 12 months
Secondary outcomes (5)
Health related Quality of Life
Fear of falling
Dependence
Use of hospital, primary care etc.
Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2008
- Study completionMar 2008
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 Accidental 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark
- Investigators
- Ane B Vind, Dr., Principal investigator, Glostrup University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226486
- Sponsor's protocol ID
- KA05059
- Status last verified
- Aug 2008
- First submitted
- 23 Sep 2005
- Last updated
- 21 Aug 2008
- Results posted
- No
Publications
Vind AB, Andersen HE, Pedersen KD, Joergensen T, Schwarz P. Effect of a program of multifactorial fall prevention on health-related quality of life, functional ability, fear of falling and psychological well-being. A randomized controlled trial. Aging Clin Exp Res. 2010 Jun;22(3):249-54. doi: 10.1007/BF03324804. Epub 2009 Nov 17.
PubMed 19934621
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination and Treatment of Elderly After a Fall- an Analysis in a Medical Technology Evaluation Perspective
- ClinicalTrials.gov ID
- NCT00226486
- Acronym / sponsor ID
- KA05059
- Conditions
- Accidental Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark
- Study start
- Sep 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 27 Sep 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.
Falls and injurious falls are common among elderly people. The aim of the study is to test a model of multifactorial fall intervention in a Danish population of elderly sustaining a fall. Focus is on prevention of further falls, patients views on fall prevention and a cost-effectiveness analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: multifactorial interventionIdentification of individual risk factors for falls and specified intervention aimed diminishing these risk factors in the individual. |
| 2 | Placebo comparator | Other: Usual careUsual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years old or older
- Having been treated in emergency department or submitted to hospital after a fall
- Living in the Glostrup area.
Key exclusion criteria (5 listed)
- Fall due to strong external force, new apoplexia cerebri, epileptic seizure, alcohol intoxication.
- Known cognitive impairment
- Not able to walk prior to fall
- Living in institution
- Planned geriatric intervention.
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 interventionIdentification of medical, cardiovascular, physical risk factors for falls; e.g. vision, drug-use, depression, carotid sinus syndrome, orthostatic hypotension, etc. Individual intervention; treatment of disease, drug review, pacemaker, exercises, new glasses, all if indicated. | Other | 1 |
| Usual careNo intervention, but ususal care after an accidental fall. | Other | 2 |
Primary outcome
Number of falls and injurious falls in 12 months
5 secondary outcomes
Health related Quality of Life
Fear of falling
Dependence
Use of hospital, primary care etc.
Mortality
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 21 Aug 2008.
- Derived from this study: PubMed 19934621Vind AB, Andersen HE, Pedersen KD, Joergensen T, Schwarz P. Effect of a program of multifactorial fall prevention on health-related quality of life, functional ability, fear of falling and psychological well-being. A randomized controlled trial. Aging Clin Exp Res. 2010 Jun;22(3):249-54. doi: 10.1007/BF03324804. Epub 2009 Nov 17.
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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.
Ane B Vind, Dr. principal investigator
Glostrup 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 multifactorial intervention in people with Accidental Falls, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 3 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 21 Aug 2008. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Number of falls and injurious falls in 12 months. 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 NCT00226486, 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 21 Aug 2008.