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CompletedNCT02475850STRIDEUpdated Mar 3, 2021Results posted

Strategies to Reduce Injuries and Develop Confidence in Elders

A Phase 3 interventional study of Evidence-based tailored fall prevention and Usual care in Accidental Falls and Wounds and Injuries, sponsored by Brigham and Women's Hospital. Completed at 10 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by Brigham and Women's Hospital · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
5,451
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Accidental Falls
  • Wounds and Injuries

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 5,451 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
5,451 participants (actual)

Study arms

  • Other
    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

  • Other
    Control

    Usual fall prevention care

    Other: Usual care

Interventions

  • OtherEvidence-based tailored fall prevention
  • OtherUsual care
06

What researchers measure

Primary outcomes

  1. First Adjudicated Serious Fall-Related Injury

    Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.

    Time frame: Enrollment through last completed follow-up or death interview (max 44 months)

Secondary outcomes

  1. First Self-reported Fall-related Injury

    Number of first self-reported fall-related injuries per 100 per years of follow-up

    Time frame: Enrollment through last completed follow-up or death interview (max 44 months)

  2. Time to Self-reported Falls

    \*\* data for this outcome was not collected

    Time frame: these data were not collected

  3. Physical Function

    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

    Time frame: measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores

  4. Disability

    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

    Time frame: measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores

  5. Anxiety

    Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.

    Time frame: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.

  6. Depression

    PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.

    Time frame: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.

  7. Fear of Falling

    Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more 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.

07

Results

Posted Mar 3, 2021

Participant flow

Participant flow — Overall Study
MilestoneIntervention - Fall Prevention Standard of CareControl
Started28022649
Completed22092165
Not completed593484
Withdrew: Death155141
Withdrew: Lost to follow-up217188
Withdrew: Withdrawal by subject221155

Outcome measures

PrimaryFirst Adjudicated Serious Fall-Related Injury

Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.

Time frame:
Enrollment through last completed follow-up or death interview (max 44 months)
Reported as:
Number · events per 100 person years of follow-up
First Adjudicated Serious Fall-Related Injury
events per 100 person years of follow-upIntervention - Fall Prevention Standard of CareControl
First Adjudicated Serious Fall-Related Injury4.87 (4.31 to 5.43)5.34 (4.55 to 6.13)
Statistical analysis
  • Intervention - Fall Prevention Standard of Care vs Control · Regression, Cox · p = 0.245 (p\<0.05 threshold (primary outcome)) · Hazard ratio (hr): 0.92 · 95% CI 0.80 to 1.06multistate model accounting for death as a semi-competing risk
SecondaryFirst Self-reported Fall-related Injury

Number of first self-reported fall-related injuries per 100 per years of follow-up

Time frame:
Enrollment through last completed follow-up or death interview (max 44 months)
Reported as:
Number · events per 100 person years of follow-up
First Self-reported Fall-related Injury
events per 100 person years of follow-upIntervention - Fall Prevention Standard of CareControl
First Self-reported Fall-related Injury25.64 (24.19 to 27.08)28.62 (26.53 to 30.72)
Statistical analysis
  • Intervention - Fall Prevention Standard of Care vs Control · Regression, Cox · p = 0.004 (p\< 0.01 threshold (secondary outcome)) · Hazard ratio (hr): 0.90 · 99% CI 0.83 to 0.99
SecondaryTime to Self-reported Falls

\*\* data for this outcome was not collected

Time frame:
these data were not collected

No measurements were reported for this outcome.

SecondaryPhysical Function

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

Time frame:
measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores
Reported as:
Least squares mean · units on a scale
Physical Function
units on a scaleIntervention - Fall Prevention Standard of CareControl
Physical Function58.45 ± 0.4857.73 ± 0.51
Statistical analysis
  • Intervention - Fall Prevention Standard of Care vs Control · Mixed Models Analysis · p = 0.309 (p \< 0.01 threshold (secondary outcome)) · Difference in least-squared means across: 0.72 · 99% CI -1.10 to 2.54random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness
SecondaryDisability

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

Time frame:
measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores
Reported as:
Least squares mean · units on a scale
Disability
units on a scaleIntervention - Fall Prevention Standard of CareControl
Disability55.16 ± 0.6354.57 ± 0.67
Statistical analysis
  • Intervention - Fall Prevention Standard of Care vs Control · Mixed Models Analysis · p = 0.528 (p \< 0.01 threshold (secondary outcome)) · Least squares means: 0.59 · 99% CI -1.80 to 0.93random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness
SecondaryAnxiety

Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.

Time frame:
Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.
Reported as:
Least squares mean · units on a scale
Anxiety
units on a scaleFall Prevention Standard of CareControl
Anxiety11.63 ± 0.2912.53 ± 0.30
Statistical analysis
  • Fall Prevention Standard of Care vs Control · Mixed Models Analysis · p = 0.037 (p \< 0.01 threshold (secondary outcome)) · Least squares means: -0.90 · 99% CI -2.00 to 0.20Difference in least-squared means across all follow-up (repeated measures: 12 months/24 months)
SecondaryDepression

PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.

Time frame:
Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.
Reported as:
Least squares mean · units on a scale
Depression
units on a scaleIntervention - Fall Prevention Standard of CareControl
Depression11.75 ± 0.3112.94 ± 0.32
Statistical analysis
  • Intervention - Fall Prevention Standard of Care vs Control · Mixed Models Analysis · p = 0.009 (p\<0.01 threshold (secondary outcome)) · Least squares means: -1.19 · 99% CI -2.36 to -0.02random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness
SecondaryFear of Falling

Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more 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.
Reported as:
Least squares mean · units on a scale
Fear of Falling
units on a scaleIntervention - Fall Prevention Standard of CareControl
Fear of Falling16.03 ± 0.3516.10 ± 0.37
Statistical analysis
  • Intervention - Fall Prevention Standard of Care vs Control · Mixed Models Analysis · p = 0.897 (p \<0.01 threshold (secondary outcome)) · Least squares means: -0.07 · 99% CI -1.38 to 1.25Difference in least-squared means across all follow-up (repeated measures: 12 months, 24 months)

Adverse events

Collected over Enrollment through death, withdrawal, or end of study (max 44 months). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention - Fall Prevention Standard of Care235/2,802 (8.4%)1,139/2,802 (40.6%)—
Control220/2,649 (8.3%)1,108/2,649 (41.8%)—
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventIntervention - Fall Prevention Standard of CareControl
hospitalizationInfections and infestations252/2802231/2649
hospitalizationCardiac disorders199/2802199/2649
hospitalizationInjury, poisoning and procedural complications187/2802196/2649
hospitalizationNervous system disorders178/2802153/2649
hospitalizationMusculoskeletal and connective tissue disorders173/2802156/2649
hospitalizationGastrointestinal disorders161/2802135/2649
hospitalizationGeneral disorders159/2802152/2649
hospitalizationRespiratory, thoracic and mediastinal disorders156/2802119/2649
hospitalizationVascular disorders101/2802119/2649
hospitalizationVascular disorders63/280277/2649

Baseline characteristics

Age, Continuous
Age, Continuous(Years)ControlInterventionTotal
Mean79.5 ± 5.879.9 ± 5.779.7 ± 5.8
Sex: Female, Male
Sex: Female, Male(Participants)ControlInterventionTotal
Female162917523381
Male102010502070
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ControlInterventionTotal
Hispanic or Latino211196407
Not Hispanic or Latino242825925020
Unknown or Not Reported101424
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ControlInterventionTotal
American Indian or Alaska Native448
Asian264470
Native Hawaiian or Other Pacific Islander156
Black or African American164128292
White239425714965
More than one race221638
Unknown or Not Reported383472
Positive on Fall Risk Screening Questions
Positive on Fall Risk Screening Questions(Participants)ControlInterventionTotal
Fallen 2 or more times in past year89610151911
Fallen and hurt yourself in past year103110892120
Fear of falling because of balance or walking problems227424054679
Educational Level
Educational Level(Participants)ControlInterventionTotal
High school graduate or less6436021245
Some college or equivalent6596971356
College graduate or higher134315022845
Unknown415
Chronic coexisting conditions - number per participant
Chronic coexisting conditions - number per participant(number chronic conditions per subject)ControlInterventionTotal
Mean2.1 ± 1.32.1 ± 1.32.1 ± 1.3
Clinically significant cognitive impairment
Clinically significant cognitive impairment(Participants)ControlInterventionTotal
Count of participants7585160

4 further baseline measures are reported on the registry.

08

Study locations

10 sites
  • Healthcare Partners
    Torrance, California, United States
  • University of Iowa Health Alliance
    Des Moines, Iowa, United States
  • Johns Hopkins Medicine
    Baltimore, Maryland, United States
  • Partners Healthcare
    Boston, Massachusetts, United States
  • Reliant Medical Group
    Worcester, Massachusetts, United States
  • University of Michigan
    Ann Arbor, Michigan, United States
  • Essentia Health
    Duluth, Minnesota, United States
  • Mt Sinai Health System
    New York, New York, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania, United States
  • University of Texas Medical Branch at Galveston
    Galveston, Texas, United States
09

References and documents

Publications

  • Ganz DA, Yuan AH, Greene EJ, Latham NK, Araujo K, Siu AL, Magaziner J, Gurwitz JH, Wu AW, Alexander NB, Wallace RB, Greenspan SL, Rich J, Volpi E, Waring SC, Dykes PC, Ko F, Resnick NM, McMahon SK, Basaria S, Wang R, Lu C, Esserman D, Dziura J, Miller ME, Travison TG, Peduzzi P, Bhasin S, Reuben DB, Gill TM. Effect of the STRIDE fall injury prevention intervention on falls, fall injuries, and health-related quality of life. J Am Geriatr Soc. 2022 Nov;70(11):3221-3229. doi: 10.1111/jgs.17964. Epub 2022 Aug 6. PubMed 35932279 ↗
  • Esserman DA, Gill TM, Miller ME, Greene EJ, Dziura JD, Travison TG, Meng C, Peduzzi PN. A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial. Clin Trials. 2021 Apr;18(2):207-214. doi: 10.1177/1740774520980070. Epub 2021 Mar 7. PubMed 33678038 ↗
  • Gill TM, Bhasin S, Reuben DB, Latham NK, Araujo K, Ganz DA, Boult C, Wu AW, Magaziner J, Alexander N, Wallace RB, Miller ME, Travison TG, Greenspan SL, Gurwitz JH, Rich J, Volpi E, Waring SC, Manini TM, Min LC, Teresi J, Dykes PC, McMahon S, McGloin JM, Skokos EA, Charpentier P, Basaria S, Duncan PW, Storer TW, Gazarian P, Allore HG, Dziura J, Esserman D, Carnie MB, Hanson C, Ko F, Resnick NM, Wiggins J, Lu C, Meng C, Goehring L, Fagan M, Correa-de-Araujo R, Casteel C, Peduzzi P, Greene EJ. Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study. J Am Geriatr Soc. 2021 Jan;69(1):173-179. doi: 10.1111/jgs.16854. Epub 2020 Oct 9. PubMed 33037632 ↗
  • Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S, Storer TW, Gazarian P, Miller ME, Travison TG, Esserman D, Carnie MB, Goehring L, Fagan M, Greenspan SL, Alexander N, Wiggins J, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace RB, Casteel C, Resnick NM, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Meng C, Allore H, Brawley BF, Eder R, McGloin JM, Skokos EA, Duncan PW, Baker D, Boult C, Correa-de-Araujo R, Peduzzi P; STRIDE Trial Investigators. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. N Engl J Med. 2020 Jul 9;383(2):129-140. doi: 10.1056/NEJMoa2002183. PubMed 32640131 ↗
  • Esserman D. From screening to ascertainment of the primary outcome using electronic health records: Challenges in the STRIDE trial. Clin Trials. 2020 Aug;17(4):346-350. doi: 10.1177/1740774520920898. Epub 2020 May 14. PubMed 32408769 ↗
  • Gill TM, McGloin JM, Shelton A, Bianco LM, Skokos EA, Latham NK, Ganz DA, Nyquist LV, Wallace RB, Carnie MB, Dykes PC, Goehring LA, Doyle M, Charpentier PA, Greene EJ, Araujo KL. Optimizing Retention in a Pragmatic Trial of Community-Living Older Persons: The STRIDE Study. J Am Geriatr Soc. 2020 Jun;68(6):1242-1249. doi: 10.1111/jgs.16356. Epub 2020 Mar 25. PubMed 32212395 ↗
  • Ganz DA, Siu AL, Magaziner J, Latham NK, Travison TG, Lorenze NP, Lu C, Wang R, Greene EJ, Stowe CL, Harvin LN, Araujo KLB, Gurwitz JH, Agrawal Y, Correa-De-Araujo R, Peduzzi P, Gill TM; STRIDE Investigators. Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study. Inj Epidemiol. 2019 Apr 15;6:14. doi: 10.1186/s40621-019-0190-2. eCollection 2019. PubMed 31245263 ↗
  • Gill TM, McGloin JM, Latham NK, Charpentier PA, Araujo KL, Skokos EA, Lu C, Shelton A, Bhasin S, Bianco LM, Carnie MB, Covinsky KE, Dykes P, Esserman DA, Ganz DA, Gurwitz JH, Hanson C, Nyquist LV, Reuben DB, Wallace RB, Greene EJ. Screening, Recruitment, and Baseline Characteristics for the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Study. J Gerontol A Biol Sci Med Sci. 2018 Oct 8;73(11):1495-1501. doi: 10.1093/gerona/gly076. PubMed 30020415 ↗

Study documents

  • Statistical analysis plan · Nov 25, 2019
  • Study protocol · Dec 31, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02475850
Lead sponsor
Brigham and Women's Hospital
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, Sinai Health System, Reliant Medical Group, Partners HealthCare, University of Michigan, University of Iowa, Essentia Health, Wake Forest University, National Institute on Aging (NIA), Patient-Centered Outcomes Research Institute, National Institutes of Health (NIH)
Responsible party
Nancy Latham (Study Director, Brigham and Women's Hospital) — Principal investigator
First posted
Jun 19, 2015
Start date
Aug 2015
Primary completion
Dec 2019
Completion
Jan 2020
Results posted
Mar 3, 2021
Last update
Mar 3, 2021

Study contacts

Shalender Bhasin, MD
principal investigator · Brigham and Women's Hospital
Thomas Gill, MD
principal investigator · Yale University
Dave Reuben, MD
principal investigator · University of California, Los Angeles
Nancy Latham, PhD
study director · Brigham and Women's Hosptial

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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