Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013078
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Safe-Grip FallInjuries Intervention A Randomized Trial
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Safe-Grip FallInjuries Intervention A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2005-06
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:
Falls are the leading cause of nonfatal injuries in the United States and the second leading cause of all unintentional injury deaths Each year fractures of the hip account for about 200000 hospitalizations among the elderly and falls are contributing factors in 40 percent of admissions to nursing homes About 30 percent of community-dwelling elderly fall each year with about 10 percent seeking emergency medical help for a fall injury Data from CDC-funded study to assess falls among the elderly SAFE suggest that as many as 41 percent of elderly patients fall at home in the year following discharge from hospitalization due in part to deconditioning associated with inactivity
Detailed Description:
Background
Falls are the leading cause of nonfatal injuries in the United States and the second leading cause of all unintentional injury deaths Each year fractures of the hip account for about 200000 hospitalizations among the elderly and falls are contributing factors in 40 percent of admissions to nursing homes About 30 percent of community-dwelling elderly fall each year with about 10 percent seeking emergency medical help for a fall injury Data from CDC-funded study to assess falls among the elderly SAFE suggest that as many as 41 percent of elderly patients fall at home in the year following discharge from hospitalization due in part to deconditioning associated with inactivity
Objectives
The controlled trial of a physical restoration PR intervention Geriatric Rehabilitation Intensive Program SAFE-GRIP is designed to improve physical functional capacity and to reduce the likelihood of falls in the elderly during the period following discharge from hospitalization or inactivitybed rest
Methods
This is a four year randomized trial of SAFE-GRIP designed to improve the physical functional capacity to reduce the likelihood of falls and to decrease the chance of injury from falls Patients at home or recently discharged to home will be randomly assigned to one of two groups PR or control upon receiving medical clearance time0 This project will provide mechanisms to establish well-designed innovative physical restoration PR protocols for the Miami VAMC and test the effects of these interventions on the rate of fallingsustaining injuries and their sequelae at home Our anticipated sample was 105 males and 105 females aged 60 years inactive at home or recently discharged to home from the Miami VAMC and a neighboring community hospital Study participants will be randomly assigned to one of two groups PR or control upon receiving medical clearance Baseline measures of physical function health care utilization ADLIADL performance and health-related quality of life will be taken following assignment to treatment conditions These same measures will be taken again at eight weeks following medical clearance and again at six months The incidence of falls will be tracked throughout the funding period for each subject Self-report of the number of falls in the year prior to hospitalization an assessment of in-home hazards and an assessment of participants post-hospitalization medication regimen will be obtained at the baseline assessment and used as covariates in the analysis of outcomes
Status
All subjects have completed the study intervention phase The projected submission date of the final report is September 30 2001 Analysis of the prospectively collected study data is underway We have acquired the HCFA Denominator Files and Inpatient Files and Part B Provider Service Files for the years 1997 1998 and 1999 The extraction of 1997 1998 and 1999 Part B Provider Service Files is almost complete and the analysis of the Inpatient Files is underway
Falls are the leading cause of nonfatal injuries in the United States and the second leading cause of all unintentional injury deaths Each year fractures of the hip account for about 200000 hospitalizations among the elderly and falls are contributing factors in 40 percent of admissions to nursing homes About 30 percent of community-dwelling elderly fall each year with about 10 percent seeking emergency medical help for a fall injury Data from CDC-funded study to assess falls among the elderly SAFE suggest that as many as 41 percent of elderly patients fall at home in the year following discharge from hospitalization due in part to deconditioning associated with inactivity
Objectives
The controlled trial of a physical restoration PR intervention Geriatric Rehabilitation Intensive Program SAFE-GRIP is designed to improve physical functional capacity and to reduce the likelihood of falls in the elderly during the period following discharge from hospitalization or inactivitybed rest
Methods
This is a four year randomized trial of SAFE-GRIP designed to improve the physical functional capacity to reduce the likelihood of falls and to decrease the chance of injury from falls Patients at home or recently discharged to home will be randomly assigned to one of two groups PR or control upon receiving medical clearance time0 This project will provide mechanisms to establish well-designed innovative physical restoration PR protocols for the Miami VAMC and test the effects of these interventions on the rate of fallingsustaining injuries and their sequelae at home Our anticipated sample was 105 males and 105 females aged 60 years inactive at home or recently discharged to home from the Miami VAMC and a neighboring community hospital Study participants will be randomly assigned to one of two groups PR or control upon receiving medical clearance Baseline measures of physical function health care utilization ADLIADL performance and health-related quality of life will be taken following assignment to treatment conditions These same measures will be taken again at eight weeks following medical clearance and again at six months The incidence of falls will be tracked throughout the funding period for each subject Self-report of the number of falls in the year prior to hospitalization an assessment of in-home hazards and an assessment of participants post-hospitalization medication regimen will be obtained at the baseline assessment and used as covariates in the analysis of outcomes
Status
All subjects have completed the study intervention phase The projected submission date of the final report is September 30 2001 Analysis of the prospectively collected study data is underway We have acquired the HCFA Denominator Files and Inpatient Files and Part B Provider Service Files for the years 1997 1998 and 1999 The extraction of 1997 1998 and 1999 Part B Provider Service Files is almost complete and the analysis of the Inpatient Files is underway
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