Phase 3
N=5,451
Strategies to Reduce Injuries and Develop Confidence in Elders
Accidental Falls · Wounds and Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02475850 ↗Enrolled (actual)
5,451
Serious AEs
41.2%
Results posted
Mar 2021
Primary outcome: Primary: First Adjudicated Serious Fall-Related Injury — 4.87; 5.34 events per 100 person years of follow-up — p=0.245
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Evidence-based tailored fall prevention (Other); Usual care (Other)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First Adjudicated Serious Fall-Related Injury |
4.87; 5.34 | 0.245 |
| SECONDARY First Self-reported Fall-related Injury |
25.64; 28.62 | 0.004 sig |
| SECONDARY Time to Self-reported Falls |
— | — |
| SECONDARY Physical Function |
58.45; 57.73 | 0.309 |
| SECONDARY Disability |
55.16; 54.57 | 0.528 |
| SECONDARY Anxiety |
11.63; 12.53 | 0.037 sig |
| SECONDARY Depression |
11.75; 12.94 | 0.009 sig |
| SECONDARY Fear of Falling |
16.03; 16.10 | 0.897 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02475850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.