Disabled PersonsOP-ENSNCT04784611
Our Peers - Empowerment and Navigational Support
A study testing Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator Intervention in people with Disabled Persons, run by University of Illinois Chicago at 1 site in United States.
Trial summary
People with physical disabilities experience well documented barriers to healthcare access, quality and outcomes. The purpose of this study is to implement and evaluate a 12-month peer health navigator intervention (called Our Peer-Empowerment and Navigational Support) designed to help Medicaid beneficiaries with… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Disabled Persons
- What is being tested?
- Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 30 Sep 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medicaid beneficiary
- self-identified as person with a disability
- ability to provide legal consent
- ability to communicate in English
Who cannot join
- diagnosis of several persistent mental illness, substance abuse, primary diagnosis of pain with narcotic management.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois, Chicago
Chicago, Illinois, 60612
About this study
Official title: Our Peers - Empowerment and Navigational Support: - A Peer Health Navigator Intervention for Medicaid Beneficiaries With Physical Disabilities
People with physical disabilities experience well documented barriers to healthcare access, quality and outcomes. The purpose of this study is to implement and evaluate a 12-month peer health navigator intervention (called Our Peer-Empowerment and Navigational Support) designed to help Medicaid beneficiaries with physical disabilities break down barriers to care through a systematic process of 1) rapport building, 2) identification of healthcare needs and priorities, 3) identification of barriers and supports, 4) co-creation of goal and action plans, and 5) provision of social and informational support. It is hypothesized that people in the interventional trial will experience: improved patient activation, increased social support, increased access to care, increased quality of care, and increased health outcomes compared to people in the control group.
Read the detailed description
The purpose of this study is to evaluate the preliminary effectiveness and social validity of the OP-ENS (Our Peers - Empowerment and Navigational Support). a 12-month peer health navigator intervention sing a clinical trial design in a sample of community-dwelling adult Medicaid beneficiaries with physical disabilities.
Participants will be recruited through community and clinical networks and screened for eligibility. Participants will be randomly assigned to either the intervention or usual care groups. Participants in the intervention group will be matched with a trained peer health navigator (who is also a person with a physical disability). Using a structure process of barrier identification, goal setting and action planning peer health navigators will work with participants to help address their healthcare needs and concerns, including such things as patient-provider communication, transportation, access to durable medical equipment. It is important to note that peer health navigators are not healthcare providers and do not provide medical or health advice. Participants in the intervention trial are asked to meet with their peer health navigator at least once a month during the study period. To encourage participation in this intervention, progressive micro-incentives are integrated into the study protocol. To promote equipoise, a similar micro-incentive schedule is created for the usual care group.
Data Collection - All participants, regardless of group assignment, will be interviewed at 3 time points (baseline, 6 months, 13 months) using a self-report measures of healthcare access, quality, and outcomes as well as measures of social support and patient activation. Data collectors will be blinded to group assignment and not involved in the delivery of the OP-ENS intervention.
Data Analysis - The investigators will employ mixed effects model using each study outcome as a time-varying dependent variable and treatment group (PHN vs. usual care) as the main fixed effect. Baseline characteristics including race/ethnicity, gender, and socioeconomic status will be entered as time-invariant covariates if baseline group differences are observed (in spite of randomization). Subject intercept will be modeled as a random effect. The null hypothesis will be rejected if a significant group*time interaction effect is observed. The investigators hypothesize that PHN will have a more favorable trajectory slope of study outcomes than the matched control group. For each hypothesis, post-hoc analysis will be conducted to assess difference in each outcome variable between the two groups at different time points. The mixed models will run using PROC MIXED from of SAS 9.3 (Cary, NC). The method of estimation will be maximum likelihood (ML). A variety of covariance structures (first order regressive, compound symmetry, toeplitz, variance components, unstructured) will be carefully examined and compared for best model fit, Akaike's Information (AIC) and Bayesian Information Criteria (BIC). These statistics are functions of the log likelihood and can be compared across models. As missing data are inevitable in a longitudinal study, values will be imputed where possible using either mean (median) substitute or formal imputation procedures such as EM algorithm if missing data are MCAR (missing completely at random) or MAR (missing at random). If missing data are NMAR (not missing at random), the "pattern mixture" approach will be used to compute a "weighted average" of the parameters that are associated with the missing data to estimate what the data would have been.
- Conditions
- Disabled Persons
- Being tested
- Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator Intervention
- Keywords
- peer health navigator, community health worker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator InterventionBehavioural
Disability peer health navigator mentored and manualized process of barriers identification, asset mapping, goal setting, and action planning along with on-going social support and information sharing.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - OP-ENS Intervention | Experimental | Participants will be matched with a peer health navigator. As part of this complex behavioral intervention, participants and peer health navigators will engage in a systematic process of barrier and strength identification, goal setting and action planning related to issues of healthcare access and quality. Participants and peers will meet at least monthly over the course of the 12-month study period (but frequency is determined by participant need). Given the nature of the disability and healthcare experience, we anticipate the needs and therefore frequency will fluctuate over the duration of the study period. Beginning in month 10, participants and peers will engage in a period of transition planning to ensure that participants have the strategies and supports in place to assume the role of their own health navigator. Receives: Behavioral: Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator Intervention |
| Group 2 - Usual Care | No intervention | Participants randomized to the usual care group will continue with their usual health and healthcare routines. Participants in the usual care group will receive a monthly newsletter with general interest information relevant to the disability community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Activation Measure (PAM) scores
13-item self-report measure of perceived knowledge, skills \&confidence in self-management
Measured: baseline to 6-months
Change in Health care access and quality using CAHPS - Adult Medicaid Survey 5.0
Self-report measure of consumer's experiences, Composite scores - access and availability of care, experience of care, special considerations for people with disabilities.
Measured: baseline to 6-months
Change in Patient Activation Measure (PAM) scores
13-item self-report measure of perceived knowledge, skills \&confidence in self-management
Measured: baseline to 13-months
Change in Health care access and quality using CAHPS - Adult Medicaid Survey 5.0
Self-report measure of consumer's experiences, Composite scores - access and availability of care, experience of care, special considerations for people with disabilities.
Measured: baseline to 13-months
Secondary outcomes (14)
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score
8-item self-report measure of an individual's physical, mental, and social health. Items are rated on a Likert-scale. The PROMIS Global scale produces a physical and a mental health score from 4 items each. (minimum raw score 4; maximum raw score 20 for each physical health and mental health.
Measured: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
8-item self-report measure of the consequences of pain on relevant aspects of life. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of pain interference.
Measured: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression Score
8-item self-report measure of negative mood, views of self, and social cognition as well as decreased positive affect and engagement. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of emotional distress.
Measured: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) fatigue
8-item self-report measure of the consequences of the experience and consequences of fatigue physical, mental and social activities. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of fatigue and fatigue impact.
Measured: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Informational Support Score
8-item short form of perceived availability of helpful information or advice. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher availability of information support..
Measured: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support Scores
8-item self report of perceived perceived feelings of being cared for and valued as a person. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of emotional support.
Measured: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scores
8-item self-report of perceived ability to perform one's usual social roles and activities. 8-item self-report measure of the consequences of pain on relevant aspects of life. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of better ability to participate in social activities and roles.
Measured: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score
8-item self-report measure of an individual's physical, mental, and social health. Items are rated on a Likert-scale. The PROMIS Global scale produces a physical and a mental health score from 4 items each. (minimum raw score 4; maximum raw score 20 for each physical health and mental health.
Measured: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
8-item self-report measure of the consequences of pain on relevant aspects of life. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of pain interference.
Measured: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) fatigue
8-item self-report measure of the consequences of the experience and consequences of fatigue physical, mental and social activities. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of fatigue and fatigue impact.
Measured: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression Score
8-item self-report measure of negative mood, views of self, and social cognition as well as decreased positive affect and engagement. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of emotional distress.
Measured: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Informational Support Score
8-item short form of perceived availability of helpful information or advice. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher availability of information support..
Measured: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support Scores
8-item self report of perceived perceived feelings of being cared for and valued as a person. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of emotional support.
Measured: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scores
8-item self-report of perceived ability to perform one's usual social roles and activities. 8-item self-report measure of the consequences of pain on relevant aspects of life. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of better ability to participate in social activities and roles.
Measured: baseline to 13-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start16 Apr 2018
- Primary completion17 Nov 2020
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disabled PersonsStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the intervention or usual care groups using block randomization with randomly selected blocks of 4, 8 or 12. Randomization sequence will be generated using SAS algorithm.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, Oakland University, Access Living
- Responsible party
- Principal investigator, Susan Magasi, University of Illinois Chicago
- Investigators
- Susan Magasi, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784611
- Sponsor's protocol ID
- 2015-1207
- Acronym
- OP-ENS
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Peers - Empowerment and Navigational Support: - A Peer Health Navigator Intervention for Medicaid Beneficiaries With Physical Disabilities
- ClinicalTrials.gov ID
- NCT04784611
- Acronym / sponsor ID
- OP-ENS / 2015-1207
- Conditions
- Disabled Persons
- Keywords
- peer health navigator, community health worker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, Oakland University, Access Living
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 5 Mar 2021 (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.
People with physical disabilities experience well documented barriers to healthcare access, quality and outcomes. The purpose of this study is to implement and evaluate a 12-month peer health navigator intervention (called Our Peer-Empowerment and Navigational Support) designed to help Medicaid beneficiaries with physical disabilities break down barriers to care through a systematic process of 1) rapport building, 2) identification of healthcare needs and priorities, 3) identification of barriers and supports, 4) co-creation of goal and action plans, and 5) provision of social and informational support. It is hypothesized that people in the interventional trial will experience: improved patient activation, increased social support, increased access to care, increased quality of care, and increased health outcomes compared to people in the control group.
Detailed description
The purpose of this study is to evaluate the preliminary effectiveness and social validity of the OP-ENS (Our Peers - Empowerment and Navigational Support). a 12-month peer health navigator intervention sing a clinical trial design in a sample of community-dwelling adult Medicaid beneficiaries with physical disabilities.
Participants will be recruited through community and clinical networks and screened for eligibility. Participants will be randomly assigned to either the intervention or usual care groups. Participants in the intervention group will be matched with a trained peer health navigator (who is also a person with a physical disability). Using a structure process of barrier identification, goal setting and action planning peer health navigators will work with participants to help address their healthcare needs and concerns, including such things as patient-provider communication, transportation, access to durable medical equipment. It is important to note that peer health navigators are not healthcare providers and do not provide medical or health advice. Participants in the intervention trial are asked to meet with their peer health navigator at least once a month during the study period. To encourage participation in this intervention, progressive micro-incentives are integrated into the study protocol. To promote equipoise, a similar micro-incentive schedule is created for the usual care group.
Data Collection - All participants, regardless of group assignment, will be interviewed at 3 time points (baseline, 6 months, 13 months) using a self-report measures of healthcare access, quality, and outcomes as well as measures of social support and patient activation. Data collectors will be blinded to group assignment and not involved in the delivery of the OP-ENS intervention.
Data Analysis - The investigators will employ mixed effects model using each study outcome as a time-varying dependent variable and treatment group (PHN vs. usual care) as the main fixed effect. Baseline characteristics including race/ethnicity, gender, and socioeconomic status will be entered as time-invariant covariates if baseline group differences are observed (in spite of randomization). Subject intercept will be modeled as a random effect. The null hypothesis will be rejected if a significant group*time interaction effect is observed. The investigators hypothesize that PHN will have a more favorable trajectory slope of study outcomes than the matched control group. For each hypothesis, post-hoc analysis will be conducted to assess difference in each outcome variable between the two groups at different time points. The mixed models will run using PROC MIXED from of SAS 9.3 (Cary, NC). The method of estimation will be maximum likelihood (ML). A variety of covariance structures (first order regressive, compound symmetry, toeplitz, variance components, unstructured) will be carefully examined and compared for best model fit, Akaike's Information (AIC) and Bayesian Information Criteria (BIC). These statistics are functions of the log likelihood and can be compared across models. As missing data are inevitable in a longitudinal study, values will be imputed where possible using either mean (median) substitute or formal imputation procedures such as EM algorithm if missing data are MCAR (missing completely at random) or MAR (missing at random). If missing data are NMAR (not missing at random), the "pattern mixture" approach will be used to compute a "weighted average" of the parameters that are associated with the missing data to estimate what the data would have been.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intervention or usual care groups using block randomization with randomly selected blocks of 4, 8 or 12. Randomization sequence will be generated using SAS algorithm.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - OP-ENS Intervention | Experimental | Behavioral: Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator InterventionParticipants will be matched with a peer health navigator. As part of this complex behavioral intervention, participants and peer health navigators will engage in a systematic process of barrier and strength identification, goal setting and action planning related to issues of healthcare access and quality. Participants and peers will meet at least monthly over the course of the 12-month study period (but frequency is determined by participant need). Given the nature of the disability and healthcare experience, we anticipate the needs and therefore frequency will fluctuate over the duration of the study period. Beginning in month 10, participants and peers will engage in a period of transition planning to ensure that participants have the strategies and supports in place to assume the role of their own health navigator. |
| Group 2 - Usual Care | No intervention | –Participants randomized to the usual care group will continue with their usual health and healthcare routines. Participants in the usual care group will receive a monthly newsletter with general interest information relevant to the disability community. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Medicaid beneficiary
- self-identified as person with a disability
- ability to provide legal consent
- ability to communicate in English
Key exclusion criteria (1 listed)
- diagnosis of several persistent mental illness, substance abuse, primary diagnosis of pain with narcotic management.
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 |
|---|---|---|
| Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator InterventionDisability peer health navigator mentored and manualized process of barriers identification, asset mapping, goal setting, and action planning along with on-going social support and information sharing. | Behavioural | Group 1 - OP-ENS Intervention |
Primary outcome
Change in Patient Activation Measure (PAM) scores
Time frame: baseline to 6-months
13-item self-report measure of perceived knowledge, skills \&confidence in self-management
Change in Health care access and quality using CAHPS - Adult Medicaid Survey 5.0
Time frame: baseline to 6-months
Self-report measure of consumer's experiences, Composite scores - access and availability of care, experience of care, special considerations for people with disabilities.
Change in Patient Activation Measure (PAM) scores
Time frame: baseline to 13-months
13-item self-report measure of perceived knowledge, skills \&confidence in self-management
Change in Health care access and quality using CAHPS - Adult Medicaid Survey 5.0
Time frame: baseline to 13-months
Self-report measure of consumer's experiences, Composite scores - access and availability of care, experience of care, special considerations for people with disabilities.
14 secondary outcomes
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression Score
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) fatigue
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Informational Support Score
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support Scores
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scores
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) fatigue
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression Score
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Informational Support Score
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support Scores
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scores
Time frame: baseline to 13-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
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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.
Susan Magasi principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator Intervention in people with Disabled Persons, run by University of Illinois Chicago 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 1 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: status not confirmed, as of the sponsor's last update on 5 Mar 2021. 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?
Results are not available in the source record.
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 Activation Measure (PAM) scores (time frame: baseline to 6-months). The study lists 4 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 5 Mar 2021.