Fall RiskFRIMNCT06573983
Fall Risk Identification and Management for Older Veterans
A study testing Strengthening (Physical Therapy, Gerofit), Medication Reconciliation (Clinical Pharmacology) and Home Safety Modification (Occupational Therapy) in people with Fall Risk, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall Risk
- What is being tested?
- Strengthening (Physical Therapy, Gerofit), Medication Reconciliation (Clinical Pharmacology) and Home Safety Modification (Occupational Therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Receives care within GeriPACT, or general PACT as needed (Aim 1); Receives care within general PACT (standard VHA primary care) (Aim 2)
- Screens positive for increased fall risk (answers "yes" to any of 3 screening questions)
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Alexander J Garbin, PhD DPT, (563) 340-7121, Alexander.Garbin@va.gov
Alexander J Garbin, PhD DPT
About this study
Official title: Development of a Fall Risk Identification and Management Model for Older Veterans
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.
Read the detailed description
Falls among older adults pose a significant risk, leading to life-altering injuries and imposing substantial healthcare costs. There is a pressing need to develop fall prevention models within the Veterans Health Administration (VHA) considering Veterans are more likely to fall than their age-matched non-Veteran counterparts, likely secondary to higher rates of functional impairment and comorbidities. Extensive research has identified numerous fall risk factors across physical, psychological, pharmacological, and environmental domains. Further, screening tools and interventions have been developed to identify and manage these risk factors, offering insight on methods to intervene early and prevent falls in older Veterans. Primary care clinics within the VHA are well-positioned to play a crucial role in preventing falls. These clinics are frequently visited by older Veterans for routine care and are widely accessible across the country. However, fall risk assessment is often not included in the standard care provided by VHA primary care clinics, mainly due to barriers like limited time, competing medical priorities, and a lack of training. Consequently, there is a missed opportunity to address fall prevention. Therefore, the investigators are developing a personalized multifactorial model called Fall Risk Identification and Management (FRIM) to prevent falls in older Veterans seen within primary care by addressing known barriers that have limited the uptake of other fall prevention models. Specifically, the FRIM model follows a three-stage process: briefly screening for fall risk during routine primary care visits, conducting telehealth visits to identify specific fall risk factors, and referring Veterans to existing VHA care pathways with established interventions for managing identified risk factors. The objectives of this CDA-2 are to refine (Aim 1; Phase 1) and assess the feasibility (Aim 2; Phase 2) of the FRIM model in preparation for a future efficacy trial. The initial phase, Aim 1, focuses on refining the FRIM model by gathering feedback on each care pathway from Veterans and clinicians through qualitative interviews following a small field test. Additionally, the investigators will assess the impact of each care pathway on fall risk factor assessments. This phase aims to enhance the model based on the integration of perceptions and outcomes. Following the refinement of the FRIM model, Aim 2 entails conducting a randomized controlled feasibility pilot study. This phase will involve the collection of both qualitative and quantitative data to evaluate the feasibility, acceptability, and candidate efficacy outcomes of the FRIM model while comparing it to VHA standard of care.
- Conditions
- Fall Risk
- Being tested
- Strengthening (Physical Therapy, Gerofit), Medication Reconciliation (Clinical Pharmacology), Home Safety Modification (Occupational Therapy)
- Keywords
- Falls, Telerehabilitation, Multifactorial, Preventative, Personalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Fall Risk Identification and Management Model | Experimental | Participants will be assessed on three fall risk factors including physical, 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, deprescription via clinical pharmacy for pharmacological fall risk, and home safety modifications via occupational therapy for environmental fall risk. Receives: Other: Strengthening (Physical Therapy, Gerofit); Other: Medication Reconciliation (Clinical Pharmacology); Other: Home Safety Modification (Occupational Therapy) |
| Standard of care | No intervention | This group will receive VHA primary care current standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Program start - 1 year post baseline
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Program start
30 second sit to stand
The 30 second sit to stand is a test of lower extremity strength, transitional movements, and balance. The test is scored based on the number of sit to stand movements. A lower number of sit to stand movements indicates worse physical function and greater physical fall risk.
Measured: Program start, 1 year after intervention end (average of 1 year post baseline)
Falls Efficacy Scale - International (FES-I)
This is a questionnaire that probes concerns about falling for sixteen activities. Concern about falling is scored based on the average concern to perform each activity ranging from 1 (not at all concerned) to 4 (very concerned).
Measured: Program start, 1 year after intervention end (average of 1 year 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.
Measured: Program start, 1 year after intervention end (average of 1 year post baseline)
Home Falls and Accidents Screening Tool Self-Report (HOME FAST - SR)
The Home Falls and Accidents and Screening Tool Self-Report 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.
Measured: Program start, 1 year after intervention end (average of 1 year 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 monthly self-report REDCap surveys as well as using the VA Data Corporate Warehouse.
Measured: Through study completion (average of 1 year)
Median cumulative number of falls
Median number of cumulative falls per Veteran will be collected using monthly self-report REDCap surveys as well as using the VA Data Corporate Warehouse.
Measured: Through study completion (average of 1 year)
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 monthly self-report REDCap surveys as well as using the VA Data Corporate Warehouse.
Measured: Through study completion (average of 1 year)
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 monthly self-report REDCap surveys as well as using the VA Data Corporate Warehouse.
Measured: Through study completion (average of 1 year)
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 monthly self-report REDCap surveys as well as using the VA Data Corporate Warehouse.
Measured: Through study completion (average of 1 year)
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 monthly self-report REDCap surveys as well as using the VA Data Corporate Warehouse.
Measured: Through study completion (average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start4 Feb 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall RiskStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alexander J Garbin, PhD DPT, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573983
- Sponsor's protocol ID
- E5024-W
- Acronym
- FRIM
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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. Data prepared for distribution under a data-sharing agreement will be further redacted to ensure privacy of study participant identity yet allow analyses to occur by other investigators. The data-sharing agreement will include requirements to protect participants' privacy and data confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Fall Risk Identification and Management Model for Older Veterans
- ClinicalTrials.gov ID
- NCT06573983
- Acronym / sponsor ID
- FRIM / E5024-W
- Conditions
- Fall Risk
- Keywords
- Falls, Telerehabilitation, Multifactorial, Preventative, Personalized
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Falls among older adults pose a significant risk, leading to life-altering injuries and imposing substantial healthcare costs. There is a pressing need to develop fall prevention models within the Veterans Health Administration (VHA) considering Veterans are more likely to fall than their age-matched non-Veteran counterparts, likely secondary to higher rates of functional impairment and comorbidities. Extensive research has identified numerous fall risk factors across physical, psychological, pharmacological, and environmental domains. Further, screening tools and interventions have been developed to identify and manage these risk factors, offering insight on methods to intervene early and prevent falls in older Veterans. Primary care clinics within the VHA are well-positioned to play a crucial role in preventing falls. These clinics are frequently visited by older Veterans for routine care and are widely accessible across the country. However, fall risk assessment is often not included in the standard care provided by VHA primary care clinics, mainly due to barriers like limited time, competing medical priorities, and a lack of training. Consequently, there is a missed opportunity to address fall prevention. Therefore, the investigators are developing a personalized multifactorial model called Fall Risk Identification and Management (FRIM) to prevent falls in older Veterans seen within primary care by addressing known barriers that have limited the uptake of other fall prevention models. Specifically, the FRIM model follows a three-stage process: briefly screening for fall risk during routine primary care visits, conducting telehealth visits to identify specific fall risk factors, and referring Veterans to existing VHA care pathways with established interventions for managing identified risk factors. The objectives of this CDA-2 are to refine (Aim 1; Phase 1) and assess the feasibility (Aim 2; Phase 2) of the FRIM model in preparation for a future efficacy trial. The initial phase, Aim 1, focuses on refining the FRIM model by gathering feedback on each care pathway from Veterans and clinicians through qualitative interviews following a small field test. Additionally, the investigators will assess the impact of each care pathway on fall risk factor assessments. This phase aims to enhance the model based on the integration of perceptions and outcomes. Following the refinement of the FRIM model, Aim 2 entails conducting a randomized controlled feasibility pilot study. This phase will involve the collection of both qualitative and quantitative data to evaluate the feasibility, acceptability, and candidate efficacy outcomes of the FRIM model while comparing it to VHA standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fall Risk Identification and Management Model | Experimental | Other: Strengthening (Physical Therapy, Gerofit), Other: Medication Reconciliation (Clinical Pharmacology), Other: Home Safety Modification (Occupational Therapy)Participants will be assessed on three fall risk factors including physical, 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, deprescription via clinical pharmacy for pharmacological fall risk, and home safety modifications via occupational therapy for environmental fall risk. |
| Standard of care | No intervention | –This group will receive VHA primary care current standard of care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Receives care within GeriPACT, or general PACT as needed (Aim 1); Receives care within general PACT (standard VHA primary care) (Aim 2)
- Screens positive for increased fall risk (answers "yes" to any of 3 screening questions)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening (Physical Therapy, Gerofit)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). | Other | Fall Risk Identification and Management Model |
| Medication Reconciliation (Clinical Pharmacology)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. | Other | Fall Risk Identification and Management Model |
| Home Safety Modification (Occupational Therapy)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. | Other | Fall Risk Identification and Management Model |
Primary outcome
Participant recruitment
Time frame: Program start
Participant recruitment will be tracked as part of feasibility. It will be determined as the proportion of Veterans screened as eligible that are recruited.
Participant retention
Time frame: Program start - 1 year post baseline
Participant retention will be tracked as part of feasibility. It will be determined as the 1-year retention rate of participants.
14 secondary outcomes
Fall risk identification burden
Time frame: Program start, Program end (average of 12 weeks)
Fall risk management burden
Time frame: Program start - Program end (average of 12 weeks)
Theoretical framework of acceptability questionnaire
Time frame: Program end (average of 12 weeks)
3 key questions
Time frame: Program start
30 second sit to stand
Time frame: Program start, 1 year after intervention end (average of 1 year post baseline)
Falls Efficacy Scale - International (FES-I)
Time frame: Program start, 1 year after intervention end (average of 1 year post baseline)
Screening Tool of Older Persons Prescriptions in older adults with high fall risk (STOPPFall)
Time frame: Program start, 1 year after intervention end (average of 1 year post baseline)
Home Falls and Accidents Screening Tool Self-Report (HOME FAST - SR)
Time frame: Program start, 1 year after intervention end (average of 1 year post baseline)
Unique number of falls.
Time frame: Through study completion (average of 1 year)
Median cumulative number of falls
Time frame: Through study completion (average of 1 year)
Time to first fall
Time frame: Through study completion (average of 1 year)
Unique number of injurious falls
Time frame: Through study completion (average of 1 year)
Median cumulative number of injurious falls
Time frame: Through study completion (average of 1 year)
Time to first injurious fall
Time frame: Through study completion (average of 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. 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. Data prepared for distribution under a data-sharing agreement will be further redacted to ensure privacy of study participant identity yet allow analyses to occur by other investigators. The data-sharing agreement will include requirements to protect participants' privacy and data confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander J Garbin, PhD DPT principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening (Physical Therapy, Gerofit), Medication Reconciliation (Clinical Pharmacology) and Home Safety Modification (Occupational Therapy) in people with Fall Risk, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander J Garbin, PhD DPT ((563) 340-7121, Alexander.Garbin@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (time frame: Program start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.