Fall Risk Identification and Management for Older Veterans

NCT06573983 | Recruiting

• 1 other identifier: E5024-W
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Falls are a common occurrence among older adults, and Veterans have an even higher risk of falling compared to non-Veterans. These falls often lead to severe health consequences, including traumatic brain injuries, hip fractures, emergency visits, hospitalizations, and even death. It is crucial to prioritize fall prevention in order to reduce injuries and enable older Veterans to age comfortably at home. Although current fall prevention programs in the Veterans Health Administration primarily focus on inpatient care and nursing homes, there is a pressing need to address falls among older Veterans living independently in the community. The proposed VA-specific Fall Risk Identification and Management (FRIM) model aims to proactively prevent falls in older Veterans who receive primary care, effectively reducing the occurrence of adverse health events associated with falls. By placing emphasis on prevention rather than reacting after falls have already happened, this initiative seeks to significantly enhance the overall well-being of older Veterans.

Conditions

Fall Risk

Keywords

Falls; Telerehabilitation; Multifactorial; Preventative; Personalized

Outcome Measures

Primary Outcomes (2)

• Participant recruitment

  Participant recruitment will be tracked as part of feasibility. It will be determined as the proportion of Veterans screened as eligible that are recruited.

  Program start

• Participant retention

  Participant retention will be tracked as part of feasibility. It will be determined as the 1-year retention rate of participants.

  Program start - 1 year post baseline

Secondary Outcomes (14)

• Fall risk identification burden

  Program start, Program end (average of 12 weeks)

• Fall risk management burden

  Program start - Program end (average of 12 weeks)

• Theoretical framework of acceptability questionnaire

  Program end (average of 12 weeks)

• 3 key questions

  Program start

• 5 times sit to stand

  Program start, 1 year after intervention end (average of 1.25 years post baseline)

Study Arms (2)

Fall Risk Identification and Management Model

EXPERIMENTAL

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.

Other: Strengthening (Physical Therapy, Gerofit); Other: Cognitive Behavioral Therapy (Clinical Psychology, Occupational Therapy); Other: Medication Reconciliation (Clinical Pharmacology); Other: Home Safety Modification (Occupational Therapy)

Standard of care

NO INTERVENTION

This group will received current standard of care within the Rocky Mountain Regional GeriPACT clinic.

Interventions

Strengthening (Physical Therapy, Gerofit) OTHER

Individuals with physical fall risk will be referred to strengthening interventions available within the VHA. These may include Physical Therapy or Gerofit (a supervised exercise program).

Fall Risk Identification and Management Model

Cognitive Behavioral Therapy (Clinical Psychology, Occupational Therapy) OTHER

Individuals with psychological fall risk will be referred psychological interventions such as cognitive behavioral therapy, which focuses on guided talking. This can be performed by VHA occupational therapists and clinical psychologists.

Fall Risk Identification and Management Model

Medication Reconciliation (Clinical Pharmacology) OTHER

Individuals with pharmacological fall risk will be referred to clinical pharmacology for medication reconciliation. This includes examining the current medication list and deprescribing medications, if appropriate.

Fall Risk Identification and Management Model

Home Safety Modification (Occupational Therapy) OTHER

Individuals with environmental fall risk will be referred to occupational therapy for home safety assessments and modifications. This will involve modifying components within the home to reduce potential fall risk factors.

Fall Risk Identification and Management Model

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Screens positive for increased fall risk within GeriPACT, or generalPACT as needed, (answers "yes" to any of 3 screening questions)
• years of age and older
• Positive screen on at least two fall risk factor assessments (Aim 1); Positive screen on at least one fall risk factor assessment (Aim 2)
• Access to telehealth
• Availability of an additional adult (e.g., caregiver or family member) to be present during the physical assessment

You may not qualify if:

• Life expectancy \<12 months, as determined by PCP
• Neurological diagnosis (e.g., cerebral vascular accident, multiple sclerosis, Parkinson's Disease)
• Moderate cognitive impairment (\<13 on telephone Montreal Cognitive Assessment (MoCA-BLIND) or \<18 on MoCA Full administered during clinic visit in the previous 3 months)
• Unstable condition that precludes safe participation in structured exercise (e.g., recent deep vein thrombosis) if expected fall risk factor is physical, as determined by PCP or chart review
• Participation in any intervention components of the FRIM model, with the intention of reducing a FRIM fall risk factor, within the past 2 months
• Currently using a wheelchair for mobilization
• If it is in the opinion of the study staff that the participant would be at an increased suicide risk due to study procedures

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities; Cognitive Behavioral Therapy; Psychology, Clinical; Occupational Therapy; Medication Reconciliation

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Psychology; Behavioral Sciences; Aftercare; Continuity of Patient Care; Patient Care; Medication Errors; Drug Therapy; Medical Errors; Health Services; Health Care Facilities Workforce and Services; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Alexander J Garbin, PhD DPT

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander J Garbin, PhD DPT

CONTACT

(563) 340-7121; Alexander.Garbin@va.gov

Jennifer E Stevens-Lapsley, PhD

CONTACT

(303) 949-9304; Jennifer.Stevens-Lapsley@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and investigators will be blinded to assignment during phase 2. Participants and care providers are unable to be blinded as delivery of treatment outside of standard of care will demonstrate group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: There are two phases to the study. The first phase will include refinement of the intervention by examining quantitative and qualitative data from a small number of participants with no control. The second phase will be a randomized feasibility pilot where the intervention group will be compared to standard of care.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication
• Access Criteria: The research team intends to share study data that may be requested from other research investigators in a data-sharing agreement provided at the study's end.

Locations

US (1)