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NCT00397410 Clinical Trial

Prevention of Hip Fractures With Soft and Hard Hip Protectors

Hip Fractures Clinical Trial

Official title:
Compliance With and Effect of Soft and Hard Hip Protectors in Norwegian Nursing Homes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00397410
Other study ID # 2004-2-0284
Secondary ID
Status Completed
Phase N/A
First received November 8, 2006
Last updated May 10, 2012
Start date May 2005
Est. completion date December 2007

Study information
Verified date May 2012
Source Norwegian Institute of Public Health
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Institute of Public Health
Study type Interventional

Clinical Trial Summary

The aim of this study is to compliance with and effect of soft and hard hip protectors in Norwegian nursing homes.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1236
Est. completion date December 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- all permanent residents in the the participating nursing homes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• Hip protectors

Locations
Country Name City State
Norway Norwegian Institute of public Health Oslo

Sponsors (2)
Lead Sponsor Collaborator
Norwegian Institute of Public Health Oslo University College

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Uptake and adherence with soft and hard hip protectors
Primary Effect of soft and hard hip protectors in protected and unprotected falls
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