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Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE)

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ClinicalTrials.gov Identifier: NCT02475850
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
Yale University
University of California, Los Angeles
Healthcare Partners
The University of Texas Medical Branch, Galveston
University of Pittsburgh Medical Center
Johns Hopkins University
Mt Sinai Health System
Reliant Medical Group
Partners HealthCare
University of Michigan
University of Iowa Health Alliance
Essentia Health
Wake Forest University
National Institute on Aging (NIA)
Patient-Centered Outcomes Research Institute
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Nancy Latham, Brigham and Women's Hospital

Brief Summary:
The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy in community dwelling older adults at risk of falls recruited from 86 primary care practices around the U.S.

Condition or disease Intervention/treatment Phase
Accidental Falls Wounds and Injuries Other: Evidence-based tailored fall prevention Other: Usual care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Trial of a Multifactorial Fall Injury Prevention Strategy
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2019
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Fall prevention standard of care
An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach
Other: Evidence-based tailored fall prevention
Control
Usual fall prevention care
Other: Usual care



Primary Outcome Measures :
  1. Adjudicated Serious Fall-Related Injuries [ Time Frame: 44 months ]
    time to first adjudicated serious fall-related injury


Secondary Outcome Measures :
  1. All Self-reported Fall-Related Injuries [ Time Frame: 44 months ]
    time to first self-reported fall-related injuries (serious and non-serious)

  2. All Self-reported Falls [ Time Frame: 44 months ]
    time to self-reported falls

  3. Function, as measured by the Late Life Function and Disability Instrument [ Time Frame: 12 months, 24 months ]
    self-report computer-adaptive measure of function

  4. Disability, as measured by the Late Life Function and Disability Instrument [ Time Frame: 12 months, 24 months ]
    self-report computer-adaptive measure of disability

  5. Anxiety as measured by the Patient-reported Outcome Measure Information System (PROMIS) Anxiety Measure [ Time Frame: 12 months, 24 months ]
    self-report measure of anxiety

  6. Depression as measured by the PROMIS Depression Measure [ Time Frame: 12 months, 24 months ]
    self-report measure of depression

  7. Fear of falling as measured by the Falls Efficacy Scale [ Time Frame: 12 months, 24 months ]
    self-report measure of fear of falling



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is at least 70 years of age.
  • The patient must answer 'yes' to one or more of the following questions:
  • Have you fallen and hurt yourself in the past year?
  • Have you fallen 2 or more times in the past year?
  • Are you afraid that you might fall because of balance or walking problems?

Exclusion Criteria:

  • The patient is enrolled in hospice.
  • The patient resides in a nursing home.
  • The patient is not capable of providing informed consent (or assent), and a proxy is not available.
  • The patient does not speak English or Spanish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475850


Locations
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United States, California
Healthcare Partners
Torrance, California, United States
United States, Iowa
University of Iowa Health Alliance
Des Moines, Iowa, United States
United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States
United States, Massachusetts
Partners Healthcare
Boston, Massachusetts, United States
Reliant Medical Group
Worcester, Massachusetts, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Essentia Health
Duluth, Minnesota, United States
United States, New York
Mt Sinai Health System
New York, New York, United States
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, Texas
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Sponsors and Collaborators
Brigham and Women's Hospital
Yale University
University of California, Los Angeles
Healthcare Partners
The University of Texas Medical Branch, Galveston
University of Pittsburgh Medical Center
Johns Hopkins University
Mt Sinai Health System
Reliant Medical Group
Partners HealthCare
University of Michigan
University of Iowa Health Alliance
Essentia Health
Wake Forest University
National Institute on Aging (NIA)
Patient-Centered Outcomes Research Institute
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Shalender Bhasin, MD Brigham and Women's Hospital
Principal Investigator: Thomas Gill, MD Yale University
Principal Investigator: Dave Reuben, MD University of California, Los Angeles
Study Director: Nancy Latham, PhD Brigham and Women's Hosptial
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nancy Latham, Study Director, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02475850    
Other Study ID Numbers: U01AG048270 ( U.S. NIH Grant/Contract )
1U01AG048270-01 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Wounds and Injuries