Hip FracturesNCT00397410
Prevention of Hip Fractures With Soft and Hard Hip Protectors
A study testing Hip protectors in people with Hip Fractures and Prevention, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
The aim of this study is to compliance with and effect of soft and hard hip protectors in Norwegian nursing homes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures, Prevention
- What is being tested?
- Hip protectors
- Type of treatment
- Medical device
- How many people
- 1,236 participants
- Where
- 1 siteNorway
- Study dates
- May 2005to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all permanent residents in the the participating nursing homes
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance With and Effect of Soft and Hard Hip Protectors in Norwegian Nursing Homes
The aim of this study is to compliance with and effect of soft and hard hip protectors in Norwegian nursing homes.
Read the detailed description
Hip fractures are a major cause of disability and functional limitation. Hip protectors have shown to have the potential to lower the risk of a fracture by reducing the impact on the hip region during falls, but low uptake and adherence have been a problem.
Changing the hip protector's design might give a higher uptake and adherence. The aim of this study is to compare uptake, adherence and effect of soft and hard hip protectors in Norwegian nursing homes. Because a soft hip protector seems to be more comfortable, we expect a higher uptake and adherence with the soft hip protector, specially when it comes to 24 hour use. If the soft hip protector has the same protective quality as the hard hip protector, the soft hip protector will be a better alternative than the hard one.
This cluster randomized study is performed in 18 Norwegian nursing homes in 2 municipalities. The study started May 15. 2006 and will end November 30. 2006.
All permanent residents are invited to participate in the study either as a user of hip protector or as a non user.
- Conditions
- Hip Fractures, Prevention
- Being tested
- Hip protectors
- Keywords
- hip protectors, uptake and adherence, Nursing home residents, efficacy, prevention
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip protectorsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake and adherence with soft and hard hip protectors
Effect of soft and hard hip protectors in protected and unprotected falls
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startMay 2005
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 1,236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Oslo University College
- Responsible party
- Principal investigator, Hege Bentzen, Norwegian Institute of Public Health
- Investigators
- Lisa Forsen, PHd, Principal investigator, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397410
- Sponsor's protocol ID
- 2004-2-0284
- Status last verified
- May 2012
- First submitted
- 8 Nov 2006
- Last updated
- 11 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With and Effect of Soft and Hard Hip Protectors in Norwegian Nursing Homes
- ClinicalTrials.gov ID
- NCT00397410
- Acronym / sponsor ID
- 2004-2-0284
- Conditions
- Hip Fractures, Prevention
- Keywords
- hip protectors, uptake and adherence, Nursing home residents, efficacy, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,236 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Oslo University College
- Study start
- May 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Nov 2006 (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 compliance with and effect of soft and hard hip protectors in Norwegian nursing homes.
Detailed description
Hip fractures are a major cause of disability and functional limitation. Hip protectors have shown to have the potential to lower the risk of a fracture by reducing the impact on the hip region during falls, but low uptake and adherence have been a problem.
Changing the hip protector's design might give a higher uptake and adherence. The aim of this study is to compare uptake, adherence and effect of soft and hard hip protectors in Norwegian nursing homes. Because a soft hip protector seems to be more comfortable, we expect a higher uptake and adherence with the soft hip protector, specially when it comes to 24 hour use. If the soft hip protector has the same protective quality as the hard hip protector, the soft hip protector will be a better alternative than the hard one.
This cluster randomized study is performed in 18 Norwegian nursing homes in 2 municipalities. The study started May 15. 2006 and will end November 30. 2006.
All permanent residents are invited to participate in the study either as a user of hip protector or as a non user.
Study design
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all permanent residents in the the participating nursing homes
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hip protectors | Device | – |
Primary outcome
Uptake and adherence with soft and hard hip protectors
Effect of soft and hard hip protectors in protected and unprotected falls
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 11 May 2012.
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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.
Lisa Forsen, PHd principal investigator
National Institute of public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip protectors in people with Hip Fractures and Prevention, run by Norwegian Institute of Public Health at 1 site in Norway.
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 0 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 11 May 2012. 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 Norway. 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?
Uptake and adherence with soft and hard hip protectors. The study lists 2 primary outcomes in all. 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 11 May 2012.