Fall Risk Identification and Management for Older Veterans
NCT Number: NCT06573983
Acronym: FRIM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fall Risk
Interventions: OTHER: Strengthening (Physical Therapy, Gerofit)|OTHER: Cognitive Behavioral Therapy (Clinical Psychology, Occupational Therapy)|OTHER: Medication Reconciliation (Clinical Pharmacology)|OTHER: Home Safety Modification (Occupational Therapy)
Sponsor: VA Office of Research and Development
Sex: ALL
Age: OLDER_ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-09-30
Locations: Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, 80045-7211, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Fall risk identification burden, Fall risk identification burden will be tracked as part of feasibility. It will be determined as the time to identify fall risk factors during telehealth visit., Program start, Program end (average of 12 weeks)|Fall risk management burden, Fall risk management burden will be tracked as part of feasibility. It will be determined as the time to complete fall risk factor management., Program start - Program end (average of 12 weeks)|Theoretical framework of acceptability questionnaire, Acceptability will be measured using an established questionnaire based on the theoretical framework of acceptability. Responses on the questionnaire range from 1 (did not like, high burden) to 5 (strongly liked, low burden)., Program end (average of 12 weeks)|3 key questions, The 3 key questions include 1) whether the older adult feels unsteady when standing or walking, 2) worries about falling, 3) or has fallen in the past year. Participant responses of 'yes' or 'no' to each question will be recorded., Program start|5 times sit to stand, The 5 times sit to stand is a test of lower extremity strength, transitional movements, and balance. The test is scored based on the time to completed 5 sit to stand movements and is highly predictive of falls and injurious falls. A higher time indicates worse physical function and greater physical fall risk., Program start, 1 year after intervention end (average of 1.25 years post baseline)|Survey of Activities and Fear of Falling in the Elderly, This survey is a questionnaire that probes fear of falling and activity restriction of eleven activities. Fear of falling is scored based on the average worry to perform each activity ranging from 0 (not worried) to 3 (very worried). Activity restriction is scored by the number of activities that an individuals reports doing less than usual compared to three years ago. Additional questions probe whether activities are restricted due to fear of falling. Higher scores indicate greater psychological fall risk., Program start, 1 year after intervention end (average of 1.25 years post baseline)|Screening Tool of Older Persons Prescriptions in older adults with high fall risk (STOPPFall), Pharmacological fall risk will be identified via the number of medications prescribed on the Screening Tool of Older Persons Prescriptions in older adults with high fall risk. The number of medications prescribed will be collected from the participant's medical record. A higher score indicates more fall risk increasing drugs and greater pharmacological fall risk., Program start, 1 year after intervention end (average of 1.25 years post baseline)|Home Falls and Accidents Screening Tool (HOME FAST), The Home Falls and Accidents and Screening Tool is a questionnaire that assesses 25 potential home fall risk factors (e.g., slippery surfaces, lighting, etc.). A higher score indicates greater environmental fall risk., Program start, 1 year after intervention end (average of 1.25 years post baseline)|Unique number of falls., Unique number of falls will be measured as a yes/no occurrence of any falls during the study. This will be measured using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse., Through study completion (average of 1.25 years)|Median cumulative number of falls, Median number of cumulative falls per Veteran will be collected using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse., Through study completion (average of 1.25 years)|Time to first fall, Time to first fall is a continuous measure of days to the first fall occurring within the study period. This will be collected using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse., Through study completion (average of 1.25 years)|Unique number of injurious falls, Injurious falls will be defined as falls requiring medical attention. Unique number of injurious falls will be measured as a yes/no occurrence of any injurious falls during the study. This will be measured using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse., Through study completion (average of 1.25 years)|Median cumulative number of injurious falls, Injurious falls will be defined as falls requiring medical attention. Median number of cumulative injurious falls per Veteran will be collected using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse., Through study completion (average of 1.25 years)|Time to first injurious fall, Injurious falls will be defined as falls requiring medical attention. Time to first injurious fall is a continuous measure of days to the first injurious fall occurring within the study period. This will be collected using weekly self-report via the Annie-App as well as using the VA Data Corporate Warehouse., Through study completion (average of 1.25 years)