Traumatic Brain InjuryACLNCT04462549
Improving Health Outcomes With Resource Facilitation
A study testing Resource Facilitation in people with Traumatic Brain Injury and Rehabilitation, run by Rehabilitation Hospital of Indiana at 1 site in United States.
Trial summary
The purpose of this research is to test a service the investigators of the study believe may increase quality of life after brain injury and reduce the level of disability that might be associated with that injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Rehabilitation, Intervention
- What is being tested?
- Resource Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Documented TBI (if one or more of the following criteria apply: Loss of consciousness of 30 minutes or more Post-traumatic anterograde amnesia of 24 hours or more Worst Glasgow Coma Scale full score in first 24 hours < 13 (unless invalidataed upon review, e.g., attributable to intoxication, sedation, systemic shock)
- One or more of the following present: Intracerebral hematoma, Subdural hematoma, Epidural hematoma, Cerebral contusion, Hemorrhagic contusion, Penetrating TBI (dura penetrated), Subarachnoid hemorrhage, Brain stem injury
- Resides in one of the following counties: Vigo, Clay, Parke, Vermillion, Fountain, Warren, Tippecanoe, Montgomery, Putnam, Owen, Monroe, Brown, Morgan, Hendricks, Boone, Clinton, Howard, Tipton, Hamilton, Marion, Johnson, Bartholomew, Shelby, Hancock, Madison, Delaware, Henry, Rush, Decatur, Randolph, Wayne, Fayette, Union, or Franklin
- Age older than 17
Who cannot join
- From or going to jail or prison following injury
- Anyone with pre-existing progressive CNS disorder (this does not include previous TBI or stroke, for example)
- Being discharged from Acute Hospital LTAC
- Anyone who cannot interact with the environment
- Unable to follow commands
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46268
About this study
Official title: Improving Health Outcomes Following Traumatic Brain Injury Through Building a TBI-informed System of Services and Supports and Resource Facilitation
The purpose of this research is to test a service the investigators of the study believe may increase quality of life after brain injury and reduce the level of disability that might be associated with that injury.
This intervention is called "Resource Facilitation" and involves working one on one with a brain injury specialist. This specialist is called a "Resource Facilitator" and will work with participants to help set and achieve their own goals along with a team of professionals that specialize in this kind of injury. If randomly assigned to the Resource Facilitation group, participants will receive Resource Facilitation free of charge. If not, they will be assigned to a control group and will not receive the intervention. However, both groups will receive calls every three months. During these calls, a research assistant will collect data about each participant's recovery and progress. If assigned to the Resource Facilitation group, participants may also receive study information in the mail if research assistants are unable to reach participants via telephone.
Read the detailed description
Approximately 2.5 million people are hospitalized each year for traumatic brain injury (TBI) in the United States, according to the Centers for Disease Control and Prevention. The Indiana State Department of Health (ISDH) found in 2013 that more than 50,000 Hoosiers suffered a traumatic brain injury (TBI). Further, the prevalence of TBI-related disability in Indiana was found to be 66,410. These findings clearly indicate that Indiana has a significant health care and social burden associated with TBI.
To date, investigators have made substantial progress through our previous TBI HRSA grants in the development and evaluation of the RF model as applied to vocational rehabilitation outcomes. However, there are many people in Indiana who do not have access to these services. Further, TBI is now recognized to be a chronic health condition, and investigators have not implemented Resource Facilitation (RF) to improve or stabilize health outcomes.
Through our 2009-2014 HRSA TBI grant, investigators became interested in the RF model, but noted the absence of empirical outcome data to support its effectiveness. To address this need, investigators conducted the first randomized controlled trial of RF with 22 participants who were recruited while they were still in acute brain injury rehabilitation, and were, on average, approximately 3 months post-injury. The participants were randomized to RF or a treatment as usual control group. After six months, it was found that 64% of the RF treatment group was successful at returning to competitive employment as compared to 36% of the control group (Wald-Wolfkowitz z = -3.277, p < .0001). While it was found that both groups had reduced level of disability at follow-up (F = 60.65, p < .0001), it was also found that the interaction for groups and time was significant (F = 9.11, p = .007) indicating that the participants who received RF were significantly less disabled at follow-up as compared to the control participants.
These findings were replicated in a larger randomized controlled trial that studied 44 participants with acquired brain injury that were again approximately 2-3 months post-injury. Participants were randomized to 12 months of RF or a treatment as usual control group. The results again demonstrated a significant advantage for the RF group (69%) for both rate of return to work as compared to the control group (50%) and how quickly they returned to work. Using a logistic regression, investigators found that group assignment was a significant predictor of vocational outcome (Wald = 4.91, p= .027) and RF participants were found to be seven times more likely to return to productive community-based work as compared to controls (95% confidence interval, 1.25-39.15). The evidence supporting the efficacy of RF seemed sufficient to support a clinical trial to examine effectiveness.
Based on these two publications, Indiana Vocational Rehabilitation supported a prospective clinical cohort study of the effectiveness of RF. In this study, investigators provided RF to 210 clients of Indiana Vocational Rehabilitation and compared their vocational outcomes to the participants in the control groups in our two previous randomized controlled trials. In contrast to our randomized controlled trials, these participants who received RF were almost 10 years post-injury. Of the 210 participants in the RF treatment group, 69% (n=145) successfully returned to competitive work. Six of these 145 successful outcomes were for participants that had a goal of return to post-high school education. Investigators compared these outcomes for the RF cohort with the outcomes attained by the control groups from our two previous randomized controlled trials and found that 48% (n=16) of the control participants successfully returned to paid employment. The difference between the two groups revealed a significant advantage for the RF group (Χ2(1)=5.39, p = .018). These results certainly provided evidence for the effectiveness of RF for helping people get back to work after acquired brain injury in a cohort referred to us by Indiana Vocational Rehabilitation.
Based on the success of our HRSA TBI grants and the results from the first two randomized controlled trials and the prospective clinical cohort study, Indiana Vocational Rehabilitation decided to support RF for any person with a brain injury and who qualified for services in 2014, and RF was made available throughout the state of Indiana by 2015. Today, approximately 350 individuals with acquired brain injury are receiving RF at any one time. However, it is quite noteworthy that investigators had more than 700 referrals from the community for RF, the vast majority of which will not qualify for Indiana Vocational Rehabilitation services. It is for these reasons that in Indiana, investigators need to expand access to RF to promote optimal health outcomes and decrease disability associated with TBI.
- Conditions
- Traumatic Brain Injury, Rehabilitation, Intervention
- Being tested
- Resource Facilitation
- Keywords
- Resource Facilitation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource FacilitationBehavioural
RF involves working one on one with a brain injury specialist. This specialist is called a "Resource Facilitator" and works with clients to help set and achieve their own goals along with a team of professionals that specialize in this kind of injury. This may include brain injury education, family education, needs assessments, and service identification.
| Study group | Role | What they receive |
|---|---|---|
| Resource Facilitation | Experimental | This group is receiving Resource Facilitation Receives: Behavioral: Resource Facilitation |
| Control | No intervention | Not receiving Resource Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient reported outcome measurement information system (PROMIS): Health Related Quality of Life (HRQL)
The PROMIS subscales are patient reported outcome measures available through NIH with excellent reliability and validity. The HRQL construct includes the following subscales: Depression, Anxiety, Physical Functioning, Social Participation, Pain Interference, Pain Intensity, Sleep Disturbance, and Fatigue. Higher scores suggest greater quality of life in the subscales above.
Measured: 3 months, 6 months, 9 months, 12 months, 15 months
Change in Quality of Life after Brain Injury (QOLIBRI)
This measures quality of life (QOL) symptoms unique to the brain injury population. Participants rate each statement from 1 (Not at all) to 5 (Very). Higher scores represent greater quality of life after experiencing brain injury
Measured: 3 months, 6 months, 9 months, 12 months, 15 months
Change in Charlson Comorbidity List
This list is a well-established list of comorbidities to chronic diseases based on the International Classification of Diseases (ICD) codes. The final score is a sum of weights associated with each comorbidity reported with higher scores representing an increased likelihood for resource use/mortality.
Measured: 3 months, 6 months, 9 months, 12 months, 15 months
Change in Traumatic Brain Injury (TBI) Symptom and Functional Status Checklist
This symptom checklist is not a normed, validated checklist, but rather a list of common brain injury symptoms observed both clinically and well-documented in the literature. This list is being piloted in this study but will provide a simple quantifier for TBI symptoms reported per patient. This form also includes key demographic information and variables that may change during the course of treatment (contact information, insurance, marital status, list of medications) that will not be considered primary outcomes.
Measured: 3 months, 6 months, 9 months, 12 months, 15 months
Change in Mayo-Portland Adaptability Inventory - IV (MPAI-4)
This measure is designed for outcome measurement after acquired brain injury in the post acute stage of recovery. The MPAI-4 is the product of 15 years of development using item response and classic psychometric theory and has established concurrent, construct, and predictive validity. There is a total score and subscale scores for Ability, Adjustment, and Participation Greater scores represent greater need in the subscales mentioned before.
Measured: 3 months, 6 months, 9 months, 12 months, 15 months
Secondary outcomes (2)
Change in Vocational Independence Scale - Revised (VIS-R)
This was created to measure the level of employment based on independence and hours worked with/without supervision. This measure was revised by the study PIs to include academic attainment. On a scale of 1-5, individuals select which statement best matches their vocational/educational status.
Measured: up to two weeks, 3 months, 6 months, 9 months, 12 months, 15 months
Change in Survey of Unmet Needs and Services Utilized (SUNSU)
This measure was designed to assess both the usage of services as well as desired services within the brain injury community. The measure shows strong internal consistency when compared to other needs assessments in the brain injury population and results in two scores: the number of items currently received (met needs) and number of items desired (unmet needs).
Measured: 3 months, 6 months, 9 months, 12 months, 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start13 Jan 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Randomized Controlled Trial 100 subjects who will participate in this study will be randomly assigned to the Resource Facilitation Group. These subjects will receive resource facilitation services in addition to their regular rehabilitation follow-up services, and 50 subjects who will participate in this study will be randomly assigned to the Regular Follow-up Group, who will only receive their regular rehabilitation follow-up services/standard of care. Randomization will be generated within RedCap.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehabilitation Hospital of Indiana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devan Parrott, Rehabilitation Hospital of Indiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462549
- Sponsor's protocol ID
- 1811467577
- Acronym
- ACL
- Status last verified
- Nov 2025
- First submitted
- 8 Aug 2019
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Outcomes Following Traumatic Brain Injury Through Building a TBI-informed System of Services and Supports and Resource Facilitation
- ClinicalTrials.gov ID
- NCT04462549
- Acronym / sponsor ID
- ACL / 1811467577
- Conditions
- Traumatic Brain Injury, Rehabilitation, Intervention
- Keywords
- Resource Facilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rehabilitation Hospital of IndianaUniversity, hospital or other
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Jul 2020 (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.
The purpose of this research is to test a service the investigators of the study believe may increase quality of life after brain injury and reduce the level of disability that might be associated with that injury.
This intervention is called "Resource Facilitation" and involves working one on one with a brain injury specialist. This specialist is called a "Resource Facilitator" and will work with participants to help set and achieve their own goals along with a team of professionals that specialize in this kind of injury. If randomly assigned to the Resource Facilitation group, participants will receive Resource Facilitation free of charge. If not, they will be assigned to a control group and will not receive the intervention. However, both groups will receive calls every three months. During these calls, a research assistant will collect data about each participant's recovery and progress. If assigned to the Resource Facilitation group, participants may also receive study information in the mail if research assistants are unable to reach participants via telephone.
Detailed description
Approximately 2.5 million people are hospitalized each year for traumatic brain injury (TBI) in the United States, according to the Centers for Disease Control and Prevention. The Indiana State Department of Health (ISDH) found in 2013 that more than 50,000 Hoosiers suffered a traumatic brain injury (TBI). Further, the prevalence of TBI-related disability in Indiana was found to be 66,410. These findings clearly indicate that Indiana has a significant health care and social burden associated with TBI.
To date, investigators have made substantial progress through our previous TBI HRSA grants in the development and evaluation of the RF model as applied to vocational rehabilitation outcomes. However, there are many people in Indiana who do not have access to these services. Further, TBI is now recognized to be a chronic health condition, and investigators have not implemented Resource Facilitation (RF) to improve or stabilize health outcomes.
Through our 2009-2014 HRSA TBI grant, investigators became interested in the RF model, but noted the absence of empirical outcome data to support its effectiveness. To address this need, investigators conducted the first randomized controlled trial of RF with 22 participants who were recruited while they were still in acute brain injury rehabilitation, and were, on average, approximately 3 months post-injury. The participants were randomized to RF or a treatment as usual control group. After six months, it was found that 64% of the RF treatment group was successful at returning to competitive employment as compared to 36% of the control group (Wald-Wolfkowitz z = -3.277, p < .0001). While it was found that both groups had reduced level of disability at follow-up (F = 60.65, p < .0001), it was also found that the interaction for groups and time was significant (F = 9.11, p = .007) indicating that the participants who received RF were significantly less disabled at follow-up as compared to the control participants.
These findings were replicated in a larger randomized controlled trial that studied 44 participants with acquired brain injury that were again approximately 2-3 months post-injury. Participants were randomized to 12 months of RF or a treatment as usual control group. The results again demonstrated a significant advantage for the RF group (69%) for both rate of return to work as compared to the control group (50%) and how quickly they returned to work. Using a logistic regression, investigators found that group assignment was a significant predictor of vocational outcome (Wald = 4.91, p= .027) and RF participants were found to be seven times more likely to return to productive community-based work as compared to controls (95% confidence interval, 1.25-39.15). The evidence supporting the efficacy of RF seemed sufficient to support a clinical trial to examine effectiveness.
Based on these two publications, Indiana Vocational Rehabilitation supported a prospective clinical cohort study of the effectiveness of RF. In this study, investigators provided RF to 210 clients of Indiana Vocational Rehabilitation and compared their vocational outcomes to the participants in the control groups in our two previous randomized controlled trials. In contrast to our randomized controlled trials, these participants who received RF were almost 10 years post-injury. Of the 210 participants in the RF treatment group, 69% (n=145) successfully returned to competitive work. Six of these 145 successful outcomes were for participants that had a goal of return to post-high school education. Investigators compared these outcomes for the RF cohort with the outcomes attained by the control groups from our two previous randomized controlled trials and found that 48% (n=16) of the control participants successfully returned to paid employment. The difference between the two groups revealed a significant advantage for the RF group (Χ2(1)=5.39, p = .018). These results certainly provided evidence for the effectiveness of RF for helping people get back to work after acquired brain injury in a cohort referred to us by Indiana Vocational Rehabilitation.
Based on the success of our HRSA TBI grants and the results from the first two randomized controlled trials and the prospective clinical cohort study, Indiana Vocational Rehabilitation decided to support RF for any person with a brain injury and who qualified for services in 2014, and RF was made available throughout the state of Indiana by 2015. Today, approximately 350 individuals with acquired brain injury are receiving RF at any one time. However, it is quite noteworthy that investigators had more than 700 referrals from the community for RF, the vast majority of which will not qualify for Indiana Vocational Rehabilitation services. It is for these reasons that in Indiana, investigators need to expand access to RF to promote optimal health outcomes and decrease disability associated with TBI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial 100 subjects who will participate in this study will be randomly assigned to the Resource Facilitation Group. These subjects will receive resource facilitation services in addition to their regular rehabilitation follow-up services, and 50 subjects who will participate in this study will be randomly assigned to the Regular Follow-up Group, who will only receive their regular rehabilitation follow-up services/standard of care. Randomization will be generated within RedCap.
| Arm | Type | Receives |
|---|---|---|
| Resource Facilitation | Experimental | Behavioral: Resource FacilitationThis group is receiving Resource Facilitation |
| Control | No intervention | –Not receiving Resource Facilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Documented TBI (if one or more of the following criteria apply: Loss of consciousness of 30 minutes or more Post-traumatic anterograde amnesia of 24 hours or more Worst Glasgow Coma Scale full score in first 24 hours < 13 (unless invalidataed upon review, e.g., attributable to intoxication, sedation, systemic shock)
- One or more of the following present: Intracerebral hematoma, Subdural hematoma, Epidural hematoma, Cerebral contusion, Hemorrhagic contusion, Penetrating TBI (dura penetrated), Subarachnoid hemorrhage, Brain stem injury
- Resides in one of the following counties: Vigo, Clay, Parke, Vermillion, Fountain, Warren, Tippecanoe, Montgomery, Putnam, Owen, Monroe, Brown, Morgan, Hendricks, Boone, Clinton, Howard, Tipton, Hamilton, Marion, Johnson, Bartholomew, Shelby, Hancock, Madison, Delaware, Henry, Rush, Decatur, Randolph, Wayne, Fayette, Union, or Franklin
- Age older than 17
Key exclusion criteria (5 listed)
- From or going to jail or prison following injury
- Anyone with pre-existing progressive CNS disorder (this does not include previous TBI or stroke, for example)
- Being discharged from Acute Hospital LTAC
- Anyone who cannot interact with the environment
- Unable to follow commands
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 |
|---|---|---|
| Resource FacilitationRF involves working one on one with a brain injury specialist. This specialist is called a "Resource Facilitator" and works with clients to help set and achieve their own goals along with a team of professionals that specialize in this kind of injury. This may include brain injury education, family education, needs assessments, and service identification. | Behavioural | Resource Facilitation |
Primary outcome
Change in Patient reported outcome measurement information system (PROMIS): Health Related Quality of Life (HRQL)
Time frame: 3 months, 6 months, 9 months, 12 months, 15 months
The PROMIS subscales are patient reported outcome measures available through NIH with excellent reliability and validity. The HRQL construct includes the following subscales: Depression, Anxiety, Physical Functioning, Social Participation, Pain Interference, Pain Intensity, Sleep Disturbance, and Fatigue. Higher scores suggest greater quality of life in the subscales above.
Change in Quality of Life after Brain Injury (QOLIBRI)
Time frame: 3 months, 6 months, 9 months, 12 months, 15 months
This measures quality of life (QOL) symptoms unique to the brain injury population. Participants rate each statement from 1 (Not at all) to 5 (Very). Higher scores represent greater quality of life after experiencing brain injury
Change in Charlson Comorbidity List
Time frame: 3 months, 6 months, 9 months, 12 months, 15 months
This list is a well-established list of comorbidities to chronic diseases based on the International Classification of Diseases (ICD) codes. The final score is a sum of weights associated with each comorbidity reported with higher scores representing an increased likelihood for resource use/mortality.
Change in Traumatic Brain Injury (TBI) Symptom and Functional Status Checklist
Time frame: 3 months, 6 months, 9 months, 12 months, 15 months
This symptom checklist is not a normed, validated checklist, but rather a list of common brain injury symptoms observed both clinically and well-documented in the literature. This list is being piloted in this study but will provide a simple quantifier for TBI symptoms reported per patient. This form also includes key demographic information and variables that may change during the course of treatment (contact information, insurance, marital status, list of medications) that will not be considered primary outcomes.
Change in Mayo-Portland Adaptability Inventory - IV (MPAI-4)
Time frame: 3 months, 6 months, 9 months, 12 months, 15 months
This measure is designed for outcome measurement after acquired brain injury in the post acute stage of recovery. The MPAI-4 is the product of 15 years of development using item response and classic psychometric theory and has established concurrent, construct, and predictive validity. There is a total score and subscale scores for Ability, Adjustment, and Participation Greater scores represent greater need in the subscales mentioned before.
2 secondary outcomes
Change in Vocational Independence Scale - Revised (VIS-R)
Time frame: up to two weeks, 3 months, 6 months, 9 months, 12 months, 15 months
Change in Survey of Unmet Needs and Services Utilized (SUNSU)
Time frame: 3 months, 6 months, 9 months, 12 months, 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resource Facilitation in people with Traumatic Brain Injury and Rehabilitation, run by Rehabilitation Hospital of Indiana 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient reported outcome measurement information system (PROMIS): Health Related Quality of Life (HRQL) (time frame: 3 months, 6 months, 9 months, 12 months, 15 months). The study lists 5 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 25 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.