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Fall Prevention Strategies for Older Adults at Risk of Falling (GREAT-FALL Trial)

N/A
Recruiting
Led By Richard D Shih, MD
Research Sponsored by Florida Atlantic University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess a program to prevent falls and injuries in older adults at risk. It will study the effectiveness of the CDC's STEADI Program.

Who is the study for?
This trial is for people over 65 who've had a fall at home. They must be living independently (not in a facility) and able to participate actively. It's not for those with severe heart or lung disease, advanced cancer, dementia, on hospice care, or dialysis.
What is being tested?
The study tests two fall-prevention strategies in older adults: one involves phone calls and the other home visits. Both are based on the CDC's STEADI program aimed at stopping falls that lead to injuries among the elderly.
What are the potential side effects?
Since this trial focuses on prevention through phone calls and home visits rather than medication, traditional side effects aren't expected. However, there may be indirect effects like stress or anxiety from participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fall-related injury at 6 months
Recurrent fall requiring ED revisit at 6 months
Secondary study objectives
All-cause mortality
Fall-related mortality
Specific fall-related injury at 6 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Phone-based fall-prevention strategyExperimental Treatment1 Intervention
The phone-based fall-prevention strategy is based on the CDC's Stopping Elderly Accidents Deaths \& Injuries (STEADI) program (https://www.cdc.gov/steadi/index.html). The STEADI Algorithm will be the template for both fall-prevention strategies utilized in this study. In addition, the CDC Check For Safety-A Home Prevention Checklist for Older Adults pamphlet will be used. At the time of study enrollment, the STEADI program written material will be provided and components of it will be discussed with the study subjects and caregivers, if present. The phone-based strategy will provide the patient and caregiver easy to read materials before ED discharge and a structured phone call around 14 days post ED discharge.
Group II: Home-visit fall prevention strategyExperimental Treatment1 Intervention
The specific components of the home-visit fall prevention strategy are similar to the Phone-Based Fall-Prevention Strategy. The essential difference is the in-person visit by the research associate to discuss and reinforce the fall-prevention strategy.
Group III: Current careActive Control1 Intervention
Current care at the ED

Find a Location

Who is running the clinical trial?

Florida Atlantic UniversityLead Sponsor
33 Previous Clinical Trials
10,029 Total Patients Enrolled
Richard D Shih, MDPrincipal InvestigatorFlorida Atlantic University

Media Library

Phone-based fall-prevention strategy Clinical Trial Eligibility Overview. Trial Name: NCT05807724 — N/A
Emergency Research Study Groups: Current care, Phone-based fall-prevention strategy, Home-visit fall prevention strategy
Emergency Clinical Trial 2023: Phone-based fall-prevention strategy Highlights & Side Effects. Trial Name: NCT05807724 — N/A
Phone-based fall-prevention strategy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05807724 — N/A
~387 spots leftby Nov 2025
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