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The HIP Impact Protection Program (HIP PRO)

This study has been completed.
Study NCT00058864.   Last updated on September 7, 2006.   Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  The HIP Impact Protection Program (HIP PRO)
Official Title  Trochanteric Padding to Prevent Hip Fractures
Brief Summary

HIP PRO is a multicenter randomized, controlled trial of an energy absorbing and distributing padding system designed to reduce the incidence of hip fractures in 546 nursing home (NH) residents. The trial is being conducted in three geographic regions of the US: Boston, St. Louis, and Baltimore. Non bed- or chair-bound residents over the age of 65 are given protective underwear containing a single pocket and hip pad so that each resident becomes his/her own control. During the trial, hip fracture incidence will be compared in padded and unpadded hips using an intent to treat analysis. A secondary aim is to identify resident and facility factors contributing to non-adherence with the use of the hip protector.

Detailed Description

The HIP PRO Study is a randomized, controlled trial of the efficacy of a trochanteric padding system in the reduction of hip fractures in nursing home residents over the age of 65 in up to 45 nursing homes in three regions: Boston, MA, St. Louis, MO, and Baltimore, MD. Eligible residents of these facilities will be screened and then evaluated during a two week run-in period during which a hip protection compliance rate of at least 67% will be required for enrollment. Recruitment of all eligible residents entering each nursing home will continue throughout the 3.5 year follow-up period.

Each subject will be given a set of 4-6 protective underwear containing a single pocket and protective pad so that each resident becomes his/her own control. The side to be protected will be based on the randomization of nursing home facilities to either right or left-sided hip protection. The hip protection underwear is designed so that it may be worn during the day and while in bed at night. Several types of underwear have been designed for residents with special needs (e.g. incontinence, dementia). Compliance and efficacy are monitored at least three times weekly across all three nursing shifts.

A hip fracture adjudication committee, blinded to the side of the fracture, will review all information (including hospital records and radiologists' reports or hip radiographs) and issue a decision on whether a fracture has occurred. Primary analyses will be performed using an "intention to treat" approach. Secondary analyses will investigate resident and nursing home factors associated with hip protection compliance and effectiveness. An independent Data and Safety Monitoring Board (DSMB) has been convened and will review hip fracture rates and adverse event data at regular intervals.

Institutions participating in HIP PRO are: a Data Coordinating Center at Maryland Medical Research Institute in Baltimore, MD; three Clinical Centers at Washington University School of Medicine in St. Louis, MO, the University of Maryland in Baltimore, MD with the University of North Carolina in Chapel Hill, NC, and the Hebrew Rehabilitation Center for Aged in Boston, MA. The Data Coordinating Center will direct the overall administrative management of the trial.

Study Phase
Study Type  Interventional
Study Design  Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Hip Fractures
Intervention  Device: Energy absorbing and distributing trochanteric pad
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  546
Start Date  September 2001
Completion Date August 2006
Eligibility Criteria 
  • Resident of eligible nursing home for at least two weeks
  • Occupying a non-Medicare, non-acute, non-rehabilitation bed in the nursing home
  • Over age 65
  • Capable of independent transfer, not chair- or bed-bound
  • Must give informed consent
Gender Both
Ages 66 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00058864
Organization ID AG0001
Secondary IDs †† 5R01AG018461-02
Study Sponsor  National Institute on Aging (NIA)
Collaborators ††
Investigators 
Information Provided By National Institute on Aging (NIA)
Verification Date September 2006
First Received Date  April 14, 2003
Last Updated Date September 7, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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