Skip to content

Safe-Grip Fall/Injuries Intervention: A Randomized Trial

Safe-Grip Fall/Injuries Intervention: A Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00013078
Enrollment
210
Registered
2001-03-16
Start date
Unknown
Completion date
2001-06-30
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls

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 200,000 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 200,000 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 inactivity/bed 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 (time=0). 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 falling/sustaining 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, ADL/IADL 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.

Interventions

PROCEDUREPhysical restoration intervention

Sponsors

South Florida Veterans Affairs Foundation for Research and Education
CollaboratorFED
US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Males and females aged 60+ years inactive at home or recently discharged to home.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026