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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
Sponsor:
Collaborator:
Oslo University College
Information provided by (Responsible Party):
Hege Bentzen, Norwegian Institute of Public Health

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study is to compliance with and effect of soft and hard hip protectors in Norwegian nursing homes.

Condition or disease Intervention/treatment Phase
Hip Fractures Prevention Device: Hip protectors Not Applicable

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
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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

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Uptake and adherence with soft and hard hip protectors
  2. Effect of soft and hard hip protectors in protected and unprotected falls

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all permanent residents in the the participating nursing homes
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


Locations
Norway
Norwegian Institute of public Health
Oslo, Norway, 0404
Sponsors and Collaborators
Norwegian Institute of Public Health
Oslo University College
Investigators
Principal Investigator: Lisa Forsen, PHd National Institute of public Health
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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