Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058864
Status:
COMPLETED
Last Update Posted:
2009-02-27
First Post:
2003-04-14
Brief Title:
The HIP Impact Protection Program HIP PRO
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Trochanteric Padding to Prevent Hip Fractures
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hisher 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 35 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 hisher 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 eg 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
Each subject will be given a set of 4-6 protective underwear containing a single pocket and protective pad so that each resident becomes hisher 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG018461-02 | NIH | None | httpsreporternihgovquickSearch5R01AG018461-02 |