NCT00058864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
546

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 27, 2009

Status Verified

February 1, 2009

Enrollment Period

4.9 years

First QC Date

April 14, 2003

Last Update Submit

February 26, 2009

Conditions

Hip Fractures

Interventions

Energy absorbing and distributing trochanteric padDEVICE

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Maryland Medical Research Institute

Baltimore, Maryland, 21210, United States

Location

Hebrew Rehabilitation Center for Aged Research and Training Institute

Boston, Massachusetts, 02131-1097, United States

Location

Washington University School of Medicine, Division of Geriatrics & Gerontology

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

  • 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.

    PMID: 17652295DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

April 14, 2003

First Posted

April 15, 2003

Study Start

September 1, 2001

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

February 27, 2009

Record last verified: 2009-02

Locations

US(4)