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Prevention of Hip Fractures With Soft and Hard Hip Protectors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397410
First Posted: November 9, 2006
Last Update Posted: May 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oslo University College
Information provided by (Responsible Party):
Hege Bentzen, Norwegian Institute of Public Health
  Purpose
The aim of this study is to compliance with and effect of soft and hard hip protectors in Norwegian nursing homes.

Condition Intervention
Hip Fractures Prevention Device: Hip protectors

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Official Title: Compliance With and Effect of Soft and Hard Hip Protectors in Norwegian Nursing Homes

Resource links provided by NLM:


Further study details as provided by Hege Bentzen, Norwegian Institute of Public Health:

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

Enrollment: 1236
Study Start Date: May 2005
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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

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 Submitted: November 8, 2006
First Posted: November 9, 2006
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