Prevention of Hip Fractures With Soft and Hard Hip Protectors
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ClinicalTrials.gov Identifier: NCT00397410 |
Recruitment Status
:
Completed
First Posted
: November 9, 2006
Last Update Posted
: May 11, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hip Fractures Prevention | Device: Hip protectors | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1236 participants |
Allocation: | Randomized |
Masking: | None (Open Label) |
Official Title: | Compliance With and Effect of Soft and Hard Hip Protectors in Norwegian Nursing Homes |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | December 2007 |
- Uptake and adherence with soft and hard hip protectors
- Effect of soft and hard hip protectors in protected and unprotected falls

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- all permanent residents in the the participating nursing homes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397410
Norway | |
Norwegian Institute of public Health | |
Oslo, Norway, 0404 |
Principal Investigator: | Lisa Forsen, PHd | National Institute of public Health |
Responsible Party: | Hege Bentzen, PhDcandidate, Norwegian Institute of Public Health |
ClinicalTrials.gov Identifier: | NCT00397410 History of Changes |
Other Study ID Numbers: |
2004-2-0284 |
First Posted: | November 9, 2006 Key Record Dates |
Last Update Posted: | May 11, 2012 |
Last Verified: | May 2012 |
Keywords provided by Hege Bentzen, Norwegian Institute of Public Health:
hip protectors uptake and adherence Nursing home residents efficacy prevention |
Additional relevant MeSH terms:
Fractures, Bone Hip Fractures Wounds and Injuries |
Femoral Fractures Hip Injuries Leg Injuries |