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The HIP Impact Protection Program (HIP PRO)

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy absorbing and distributing trochanteric pad
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fractures

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland, Baltimore
  • Maryland Medical Research Institute
  • Hebrew Rehabilitation Center for Aged Research and Training Institute
  • Washington University School of Medicine, Division of Geriatrics & Gerontology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 14, 2003
Last Updated
February 26, 2009
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00058864
Brief Title
The HIP Impact Protection Program (HIP PRO)
Official Title
Trochanteric Padding to Prevent Hip Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
546 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Energy absorbing and distributing trochanteric pad

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Maryland Medical Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21210
Country
United States
Facility Name
Hebrew Rehabilitation Center for Aged Research and Training Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131-1097
Country
United States
Facility Name
Washington University School of Medicine, Division of Geriatrics & Gerontology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17652295
Citation
Kiel DP, Magaziner J, Zimmerman S, Ball L, Barton BA, Brown KM, Stone JP, Dewkett D, Birge SJ. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007 Jul 25;298(4):413-22. doi: 10.1001/jama.298.4.413.
Results Reference
derived

Learn more about this trial

The HIP Impact Protection Program (HIP PRO)

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