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Behavioural Intervention

Fall Risk Management for Older Veterans (FRIM Trial)

N/A
Waitlist Available
Led By Alexander J Garbin, PhD DPT
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
65 years of age and older
Be older than 65 years old
Must not have
Neurological diagnosis (e.g., cerebral vascular accident, multiple sclerosis, Parkinson's Disease)
Currently using a wheelchair for mobilization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up program start, 1 year after intervention end (average of 1.25 years post baseline)
Awards & highlights

Summary

This trial aims to prevent falls among older Veterans living independently in the community by identifying those at risk and providing proactive care to reduce the occurrence of injuries and adverse health events associated with falls.

Who is the study for?
This trial is for older Veterans who are at risk of falling and live independently. It's designed to help them avoid falls and the serious injuries that can result. To join, they should be receiving primary care through the Veterans Health Administration.
What is being tested?
The FRIM model being tested includes physical therapy exercises to strengthen muscles, reviews of medications by clinical pharmacologists, changes at home recommended by occupational therapists to make it safer, and cognitive behavioral therapy to improve mental health.
What are the potential side effects?
Since this trial involves non-invasive interventions like exercise and counseling rather than medication, side effects may include muscle soreness from physical therapy or emotional discomfort during psychological therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a neurological condition like stroke, MS, or Parkinson's.
Select...
I use a wheelchair to get around.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~program start, 1 year after intervention end (average of 1.25 years post baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and program start, 1 year after intervention end (average of 1.25 years post baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participant recruitment
Participant retention
Secondary study objectives
3 key questions
5 times sit to stand
Fall risk identification burden
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fall Risk Identification and Management ModelExperimental Treatment4 Interventions
Participants will be assessed on four fall risk factors including physical, psychological, pharmacological, and environmental. If a participant screens positive for a fall risk factor, they will then be referred to an existing VHA care pathway. The care pathways include: strengthening via physical therapy or Gerofit for physical fall risk, cognitive behavioral therapy via clinical psychology or occupational therapy for psychological fall risk, deprescription via clinical pharmacy for pharmacological fall risk, and home safety modifications via occupational therapy for environmental fall risk.
Group II: Standard of careActive Control1 Intervention
This group will received current standard of care within the Rocky Mountain Regional GeriPACT clinic.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,962 Total Patients Enrolled
Alexander J Garbin, PhD DPTPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO
~72 spots leftby Dec 2028
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