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Safe-Grip Fall/Injuries Intervention: A Randomized Trial

This study has been completed.
Sponsor:
Collaborator:
South Florida Veterans Affairs Foundation for Research and Education
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013078
First received: March 14, 2001
Last updated: April 23, 2012
Last verified: June 2005
  Purpose

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.


Condition Intervention
Accidental Falls
Procedure: Physical restoration intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safe-Grip Fall/Injuries Intervention: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 210
Study Completion Date: June 2001
Arms Assigned Interventions
Arm 1 Procedure: Physical restoration intervention

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013078

Locations
United States, Florida
VA Medical Center
Miami, Florida, United States, 33125
Sponsors and Collaborators
South Florida Veterans Affairs Foundation for Research and Education
Investigators
Principal Investigator: Carolee A. DeVito, PhD MPH Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013078     History of Changes
Other Study ID Numbers: IIR 94-003
Study First Received: March 14, 2001
Last Updated: April 23, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on November 20, 2014