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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
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
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

Tracking Information
First Submitted Date  ICMJE June 1, 2015
First Posted Date  ICMJE June 19, 2015
Results First Submitted Date  ICMJE January 13, 2021
Results First Posted Date  ICMJE March 3, 2021
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
First Adjudicated Serious Fall-Related Injury [ Time Frame: Enrollment through last completed follow-up or death interview (max 44 months) ]
Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
Serious Fall-Related Injuries [ Time Frame: 1.5 to 3 years (average 2.25 years) ]
time to first serious fall-related injury
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
  • First Self-reported Fall-related Injury [ Time Frame: Enrollment through last completed follow-up or death interview (max 44 months) ]
    Number of first self-reported fall-related injuries per 100 per years of follow-up
  • Time to Self-reported Falls [ Time Frame: these data were not collected ]
    ** data for this outcome was not collected
  • Physical Function [ Time Frame: measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores ]
    Late Life Function and Disability Instrument (LL-FDI) function score. The scores are on a 0-100 scale, higher score = better function. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment
  • Disability [ Time Frame: measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores ]
    Late Life Function and Disability Instrument (LL-FDI) disability score. The scores are on a 0-100 scale, higher score = less disability. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment
  • Anxiety [ Time Frame: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores. ]
    Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.
  • Depression [ Time Frame: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores. ]
    PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.
  • Fear of Falling [ Time Frame: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores. ]
    Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more fear of falling.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
  • All Fall-Related Injuries [ Time Frame: 1.5 to 3 years (average 2.25 years) ]
    time to all fall-related injuries (serious and non-serious)
  • All Falls [ Time Frame: 1.5 to 3 years (average 2.25 years) ]
    time to all falls
  • Function, as measured by the Late Life Function and Disability Instrument [ Time Frame: Baseline, 12 months, 24 months ]
    self-report computer-adaptive measure of function
  • Disability, as measured by the Late Life Function and Disability Instrument [ Time Frame: Baseline, 12 months, 24 months ]
    self-report computer-adaptive measure of disability
  • Anxiety as measured by the Patient-reported Outcome Measure Information System (PROMIS) Anxiety Measure [ Time Frame: Baseline, 12 months, 24 months ]
    self-report measure of anxiety
  • Depression as measured by the PROMIS Depression Measure [ Time Frame: Baseline, 12 months, 24 months ]
    self-report measure of depression
  • Fear of falling as measured by the Falls Efficacy Scale [ Time Frame: Baseline, 12 months, 24 months ]
    self-report measure of fear of falling
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strategies to Reduce Injuries and Develop Confidence in Elders
Official Title  ICMJE Randomized Trial of a Multifactorial Fall Injury Prevention Strategy
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.
Detailed Description

Objective: To determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy implemented within primary care practices using usual health care resources

Design: This study is a cluster randomized, parallel group superiority trial with practices stratified by healthcare system and patients nested within practices. The unit of randomization is the practice.

Study Duration: The total study duration is 5 years. Recruitment will take place over 20 months, with follow-up taking place for 24 months - 44 months depending on date of enrollment.

Trial Sites: 86 primary care practices that are part of 10 trial sites located around the U.S.: The Partners' Health Care System; Essentia; Hopkins Health Care System; HealthCare Partners; Reliant Health Care System; Mount Sinai Health Care System; University of Pittsburgh Health Care System; University of Texas Medical Branch Health Care System; University of Iowa Health Care System; University of Michigan Health Care System.

Number of Subjects: The original target sample size was 6,000 participants enrolled in 86 practices to provide 90% power to detect a 20% reduction in the rate of the primary outcome with intervention relative to control. The study was originally designed for a study duration of 36 months with 18 months of recruitment and a minimum of 18 months of follow-up. The study was extended to a 44 month study (20 months of recruitment and a minimum 24 month of follow-up). For a 44 month trial, it was estimated that a sample size of 5,322 subjects would provide 90% power to detect a 20% reduction in the rate of the primary outcome with the intervention relative to control.

Main Inclusion Criteria Community-living persons, 70 years or older, who are at increased risk for serious fall injuries.

Intervention: 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 Center for Disease Control's (CDC's) "STEADI" toolbox (Stopping Elderly Accidents, Disability and Injury) and the joint American Geriatrics Society/British Geriatrics Society guidelines, and Assessing Care of Vulnerable Elders (ACOVE) practice change approach. The fall prevention strategies will be systematically implemented into clinical practice using: delivery system design to improve quality (Co-management); decision support (algorithms); information systems (software); self-management support (patient/caregiver engagement and activation); and linkage to community-based resources.

Primary Outcome: The primary outcome is adjudicated serious fall injuries, operationalized as a fall resulting in: (1) (fracture other than thoracic/lumbar vertebral; joint dislocation; or cut requiring closure) AND any medical attention; OR (2) (head injury; sprain or strain; bruising or swelling; or other) requiring hospitalization.

Primary Analysis: The risk of any serious fall injury (i.e., time to first event) will be analyzed using a survival model that incorporates competing risks (due to death) and clustering. In this analysis, participants who are lost to follow-up without a prior serious fall-related injury will be censored at their date last seen. In a sensitivity analysis, the investigators will adjust for the pre-specified set of baseline covariates to examine their influence on the intervention effect.

Secondary Outcomes: All self-reported falls, all self-reported fall-related injuries, and measures of well-being.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Accidental Falls
  • Wounds and Injuries
Intervention  ICMJE
  • Other: Evidence-based tailored fall prevention
  • Other: Usual care
Study Arms  ICMJE
  • 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
    Intervention: Other: Evidence-based tailored fall prevention
  • Control
    Usual fall prevention care
    Intervention: Other: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2017)
5451
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2015)
6000
Actual Study Completion Date  ICMJE January 2020
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02475850
Other Study ID Numbers  ICMJE U01AG048270( U.S. NIH Grant/Contract )
1U01AG048270-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nancy Latham, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Brigham and Women's Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP