Prevention of Hip Fractures With Soft and Hard Hip Protectors

This study has been completed.

Sponsor:

Collaborator:

Oslo University College

Information provided by (Responsible Party):

Hege Bentzen, Norwegian Institute of Public Health

ClinicalTrials.gov Identifier:

NCT00397410

First received: November 8, 2006

Last updated: May 10, 2012

Last verified: May 2012

History of Changes

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 Endpoint Classification: Efficacy Study Masking: Open Label
Official Title:	Compliance With and Effect of Soft and Hard Hip Protectors in Norwegian Nursing Homes

Resource links provided by NLM:

MedlinePlus related topics: Fractures Hip Injuries and Disorders Nursing Homes

U.S. FDA Resources

Further study details as provided by 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


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

all permanent residents in the the participating nursing homes

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	November 8, 2006
Last Updated:	May 10, 2012
Health Authority:	Norway: Norwegian Institute of Public Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016

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