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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
GREAT-FALL Trial 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.Check my eligibility
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.See study design
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.
GREAT-FALL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fall-related injury at 6 months
Recurrent fall requiring ED revisit at 6 months
Secondary outcome measures
All-cause mortality
Fall-related mortality
Specific fall-related injury at 6 months
GREAT-FALL 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
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Who is running the clinical trial?
Florida Atlantic UniversityLead Sponsor
29 Previous Clinical Trials
8,729 Total Patients Enrolled
Richard D Shih, MDPrincipal InvestigatorFlorida Atlantic University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot state my name or point to objects due to dementia.I have been hospitalized for heart failure at least twice in the last 6 months.I am currently receiving treatment for severe leukemia, multiple myeloma, or lymphoma and may need a transfusion.I am currently in hospice or receiving palliative care.I am on dialysis for end-stage kidney disease.My cancer has spread to other parts of my body.I am over 65, had a fall at home, and live at my own place.I have severe emphysema with two or more hospital visits in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Current care
- Group 2: Phone-based fall-prevention strategy
- Group 3: Home-visit fall prevention strategy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still underway for this experiment?
"Clinicaltrials.gov records show that enrolment in this medical trial is inactive, with the initial post being on April 1st 2023 and an update to its status occurring on March 29th 2023. Although recruitment has ceased for now, there are still 1009 other trials seeking participants at present."
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