Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE)
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| ClinicalTrials.gov Identifier: NCT02475850 |
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Recruitment Status :
Active, not recruiting
First Posted : June 19, 2015
Last Update Posted : January 14, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Accidental Falls Wounds and Injuries | Other: Evidence-based tailored fall prevention Other: Usual care | Phase 3 |
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 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 secondary analysis, the investigators will adjust for the pre-specified set of baseline covariates to examine their influence on the intervention effect.
Secondary Outcomes: Number of falls, number of all fall-related injuries, and measures of well-being.
| 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 : | March 31, 2019 |
| Estimated Study Completion Date : | April 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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
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Other: Evidence-based tailored fall prevention |
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Control
Usual fall prevention care
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Other: Usual care |
- Serious Fall-Related Injuries [ Time Frame: 24 months to 44 months ]time to first serious fall-related injury
- All Fall-Related Injuries [ Time Frame: 24 months to 44 months ]time to all fall-related injuries (serious and non-serious)
- All Falls [ Time Frame: 24 months to 44 months ]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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | 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:
- 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
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
| 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 | |
| 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):
| 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: | January 14, 2020 |
| Last Verified: | January 2020 |
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Wounds and Injuries |