|
The HIP Impact Protection Program (HIP PRO) Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about The HIP Impact Protection Program (HIP PRO) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. The HIP Impact Protection Program (HIP PRO) Clinical research trials and The HIP Impact Protection Program (HIP PRO) health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including The HIP Impact Protection Program (HIP PRO). The HIP Impact Protection Program (HIP PRO) Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a The HIP Impact Protection Program (HIP PRO) clinical trial. Human subjects often get the best healthcare possible for their The HIP Impact Protection Program (HIP PRO) condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > The HIP Impact Protection Program (HIP PRO)  The HIP Impact Protection Program (HIP PRO)
The HIP Impact Protection Program (HIP PRO)
For Condition: Hip Fractures
Status: Recruiting
Sponsor(s): National Institute on Aging (NIA) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 66 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 546
Location and Contact Information:
University of Maryland, Baltimore *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Jay Magaziner 410-706-2406
Hebrew Rehabilitation Center for Aged Research and Training Institute *Recruiting*
Boston, Massachusetts, 02131-1097
United States
Recruiting Douglas Kiel 617-363-8544
Washington University School of Medicine, Division of Geriatrics & Gerontology *Recruiting*
St. Louis, Missouri, 63108
United States
Recruiting Stanley Birge 314-286-2708
Maryland Medical Research Institute *Recruiting*
Baltimore, Maryland, 21210
United States
Recruiting Bruce Barton 410-532-0222
Additional Information:
Study ID Numbers: AG0001; 5R01AG018461-02
Study Start Date: September 2001
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058864
Other Hip Fractures Studies:
1. Effects of exercise on markers of inflammation in skeletal muscle in elderly hip fracture patients
2. The HIP Impact Protection Program (HIP PRO)
Related Studies:
Other Hip Fractures Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
The HIP Impact Protection Program (HIP PRO)
|
|
|
|
|
|
|
|
