Burnout, ProfessionalMCDICNCT04442438
Effect of Implementation of a Moral Case Delibration Meetings on the Prevalence of Burn-out Syndrome in the ICU
A study testing Monthly moral case deliberation in people with Burnout, Professional and Caregiver Exhaustion, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
Burnout syndrome (BOS) has a high prevalence in critical care nurses and physicians. Both personal characteristics and work-related factors have been associated with BOS. Despite this high prevalence of burnout and its potential for serious consequences, few studies have tested interventions to address the problem. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Caregiver Exhaustion
- What is being tested?
- Monthly moral case deliberation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Oct 2019to 1 Nov 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ICU professionals age 16 years or older working in intensive care departments in the Radboud University Medical Centre or the Canisius Wilhelmina Hospital
- gave written informed consent
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Radboud university medical centre
Nijmegen, Gelderland, 6525 GA
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532 SZ
About this study
Official title: Moral Case Deliberation on the Intensive Care: Effect of Implementation of a Moral Case Delibration Meetings on the Prevalence of Burn-out Syndrome in the ICU
Burnout syndrome (BOS) has a high prevalence in critical care nurses and physicians. Both personal characteristics and work-related factors have been associated with BOS. Despite this high prevalence of burnout and its potential for serious consequences, few studies have tested interventions to address the problem. Whereas person-directed interventions may be effective for periods less than 6 months, changes in the organization tend to have a longer lasting effect. Lack of participation in morally complex decision-making is assumed to be an important risk factor for the development of burnout symptoms. Implementation of structured, multi-professional medical ethical decision-making - so called moral case deliberation (MCD) - is proven feasible in an ICU setting. Health care workers involved in patient care perceived that active participation in ethical decision making resulted in better awareness of the background of the individual decisions and improved understanding of the ethical dilemma. The effects of this intervention on health-care workers well-being was not investigated.
Read the detailed description
Studies have shown that healthcare professionals working at the ICU are exposed to greater risk of developing burnout than colleagues working in other fields of medicine (Moss, Good, Gozal, Kleinpell, \& Sessler, 2016). It is widely suggested that moral distress, resulting from morally problematic situations particular for the ICU, is an important risk factor for burnout (Fumis, Junqueira Amarante, de Fatima Nascimento, \& Vieira Junior, 2017). One suggested way to help caregivers mitigate moral distress is moral case deliberation. Moral case deliberation is a structured dialogue between healthcare providers about ethically problematic situations in their daily practice. It has been widely held that frequent moral case deliberation may help healthcare providers to better appreciate moral problems, to learn about their own and others' moral viewpoints, to foster a sense cohesion within their team and to mitigate moral distress (Haan, van Gurp, Naber, \& Groenewoud, 2018). Moral case deliberation may particularly help professionals if it is based on professionals' own objectives in and experiences and expectations of moral case deliberation. It is therefore needed to firmly root moral case deliberation in the ICU practice together with/with the help of ICU-professionals (Weidema, van Dartel, \& Molewijk, 2016). Healthcare professionals themselves are best able to evaluate, learn from and adjust the practice of moral case deliberation on the ICU.
This research sets out to assess the claim that moral case deliberation can help mitigate moral distress among healthcare providers and as such reduce the risk of burnout. It does so by employing Mixed Methods Action Research (MMAR), through which the research will be conducted through and with ICU-professionals, creating co-ownership of moral case deliberation among participants. The study hopes to achieve that, instead of developing burnout as a consequence of moral distress, moral case deliberation will help IC professionals learn from morally distressing situations, potentially leading to cultural an organizational improvement and improvement of quality of care.
Research questions to be answered:
- How does moral distress, as a supposed risk factor for burnout of IC-professionals, relate to other risk factors of burnout, personality, negative work-home interactions and the ICU context?
- How do IC-professionals experience preparation, participation and the impact on daily practice of particular moral case deliberations?
- Does moral case deliberation lead to a reduction of moral distress, burnout and team cohesion?
- How can IC-professionals establish cumulative learning from moral case deliberation throughout their department?
Methods:
Quantitative methods Quantitative methods will be used to assess questions 1 and 3. Survey data will be gathered in a stepped wedge trial. Surveys will be sent to around 450 ICU-professionals which are nested in six ICUs, nested in two hospitals. The data thus has a multilevel structure (individuals in units in hospitals). The study aims for a response rate of 50% or higher, including more than 230 participants. This is expectation is formulated on the basis of the departments' experience of response rates in previous studies done in this population. During the trial, the different ICUs will receive the intervention in a stepwise manner. Within a stepped wedge design, what is randomized is the time point at which a unit receives the intervention. One unit starts in January 2020 and will receive the intervention for the full two years. Two units will start participating as of July 2020 and will then participate until December 2021. In January 2021, two other units will start participating. The last unit will receive the intervention as of July 2021 and participate for the remaining six months.
Survey data will be gathered at five measurement points, after every 6 months, the first being a baseline measurement. The baseline measurement will take place before January 2020, the second measurement will take place before July 2020, the third measurement will take in the months preceding January 2021, the fourth measurement will take place in the months preceding July 2021 and the last measurement will take place in December 2021. The survey consists of validated measurements for burnout syndrome (UBOS-C), moral distress (MDS-R), work-home interaction (SWING), personality (BFI), departmental culture (Culture of Care Barometer) and team cohesion (a set of six questions taken from the Safety Attitudes Questionnaire).
The baseline data will inspire answering research question 1. Hierarchical linear regression analysis will be used to assess the association between several concepts (e.g. moral distress, work-home interaction, personality). With hierarchical regression analysis, the explaining variance of moral distress on burn-out, controlled for burnout risk factors such as work-home interaction and personality, will be analysed. Hierarchical linear regression is a framework for model comparison: several regression models are built by adding variables to previous model at each new step and thus, later models always include the previous smaller models. The question is whether the newly added variable shows a significant improvement in the proportion of explained variance of burnout (the R2).
The survey data gathered at all five measurement points is suited for analysis which allows for assessment of question 3. The data gathered in the stepped wedge design, in which clusters (units) are randomized, is well suited for interrupted time series analysis. Interrupted time series analysis is used to evaluate the effect of an intervention in longitudinal data. The key assumption of interrupted time series analysis of this data is that moral case deliberation, as an intervention, changes the pre-intervention trend of burnout prevalence among ICU-professionals; in other words, it assumes that the pre-intervention trend would continue unchanged into the post-intervention period if there had not been an intervention. Training, as well as the advice of an expert statistician (Steven Teerenstra), will be sought to gain better insight in conducting interrupted time series analysis.
- Conditions
- Burnout, Professional, Caregiver Exhaustion
- Being tested
- Monthly moral case deliberation
- Keywords
- Moral case deliberation, Moral distress, Cohort study, Intensive care units, Quality of care, Moral development, Organizational culture
- Medical subject headings
- Burnout, Professional, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly moral case deliberationOther
Once per month, ICU professionals will take part in moral case deliberation. As part of the intervention, two or three ICU professionals (physicians and nurses) are tasked with selecting a case for moral discussion. Moral case deliberation is attended by around thirty individuals per month per unit. A feedback system will be developed used to spread the knowledge/insights from the case deliberation to all professionals in the unit.
| Study group | Role | What they receive |
|---|---|---|
| Intensive care unit 1 | Experimental | Receives of intervention consisting of monthly moral case deliberation (ethical decision-making) meetings, planned and set up by ICU professionals which have received the task of being more attentive to ethical situations during work. Receives: Other: Monthly moral case deliberation |
| Intensive care unit 2 | Other | First non-intervention, then flips to experimental arm type after six months. Receives: Other: Monthly moral case deliberation |
| Intensive care unit 3 | Other | First non-intervention, then flips to experimental arm type after six months. Receives: Other: Monthly moral case deliberation |
| Intensive care unit 4 | Other | First non-intervention, then flips to experimental arm type after twelve months. Receives: Other: Monthly moral case deliberation |
| Intensive care unit 5 | Other | First non-intervention, then flips to experimental arm type after twelve months. Receives: Other: Monthly moral case deliberation |
| Intensive care unit 6 | Other | First non-intervention, then flips to experimental arm type after Eighteen months. Receives: Other: Monthly moral case deliberation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout - measured by the Utrecht Burnout Scale (UBOS-C) survey instrument
An excessive reaction to stress caused by one's environment that may be Burnout is characterized by feelings of emotional and physical exhaustion, coupled with a sense of frustration and failure. This is measured through the Utrecht Burnout Scale (UBOS-C) survey instrument, a Dutch version of the Maslach Burnout Inventory (MBI), containing 20 items. The MBI measures three dimensions of burnout: emotional exhaustion, depersonalisation and personal accomplishment on 0 to 6 scales. Higher scores on emotional exhaustion and depersonalisation mean a worse outcome, while a higher score on personal accomplishment means a better outcome.
Measured: six months
Secondary outcomes (1)
Moral distress - measured by the 21-item moral distress scale (revised version) survey instrument
Moral distress is the emotional state that arises from a situation when an ICU professional feels that the ethically correct action to take is different from what he or she is tasked with doing. When policies or procedures prevent a professional from doing what he or she thinks is right, that presents a moral dilemma. Moral distress will be measured by the moral distress scale, a survey instrument containing 21 items. Participants are asked to rate all these situations in terms of frequency and intensity on scales ranging from 0 to 4. A total moral distress scale is calculated by multiplying frequency and intensity and adding all items together, which makes up a score between 0 and 336. A higher value means a worse outcome.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Oct 2019
- Primary completion1 Sep 2021
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Longitudinal Stepped Wedge cluster randomized Trial with an open cohort
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Marieke Zegers, Radboud University Medical Center
- Investigators
- Jelle Van Gurp, PhD, Principal investigator, IQ healthcare, Radboud University medical centerHans Van der Hoeven, MD, PhD, Principal investigator, Intensive care, Radboud Univesity medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442438
- Sponsor's protocol ID
- CH2018-01
- Acronym
- MCDIC
- Status last verified
- Nov 2022
- First submitted
- 17 Jun 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kok N, Zegers M, Teerenstra S, Fuchs M, van der Hoeven JG, van Gurp JLP, Hoedemaekers CWE. Effect of Structural Moral Case Deliberation on Burnout Symptoms, Moral Distress, and Team Climate in ICU Professionals: A Parallel Cluster Randomized Trial. Crit Care Med. 2023 Oct 1;51(10):1294-1305. doi: 10.1097/CCM.0000000000005940. Epub 2023 Jun 5.
PubMed 37272981
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moral Case Deliberation on the Intensive Care: Effect of Implementation of a Moral Case Delibration Meetings on the Prevalence of Burn-out Syndrome in the ICU
- ClinicalTrials.gov ID
- NCT04442438
- Acronym / sponsor ID
- MCDIC / CH2018-01
- Conditions
- Burnout, Professional, Caregiver Exhaustion
- Keywords
- Moral case deliberation, Moral distress, Cohort study, Intensive care units, Quality of care, Moral development, Organizational culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 22 Jun 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.
Burnout syndrome (BOS) has a high prevalence in critical care nurses and physicians. Both personal characteristics and work-related factors have been associated with BOS. Despite this high prevalence of burnout and its potential for serious consequences, few studies have tested interventions to address the problem. Whereas person-directed interventions may be effective for periods less than 6 months, changes in the organization tend to have a longer lasting effect. Lack of participation in morally complex decision-making is assumed to be an important risk factor for the development of burnout symptoms. Implementation of structured, multi-professional medical ethical decision-making - so called moral case deliberation (MCD) - is proven feasible in an ICU setting. Health care workers involved in patient care perceived that active participation in ethical decision making resulted in better awareness of the background of the individual decisions and improved understanding of the ethical dilemma. The effects of this intervention on health-care workers well-being was not investigated.
Detailed description
Studies have shown that healthcare professionals working at the ICU are exposed to greater risk of developing burnout than colleagues working in other fields of medicine (Moss, Good, Gozal, Kleinpell, \& Sessler, 2016). It is widely suggested that moral distress, resulting from morally problematic situations particular for the ICU, is an important risk factor for burnout (Fumis, Junqueira Amarante, de Fatima Nascimento, \& Vieira Junior, 2017). One suggested way to help caregivers mitigate moral distress is moral case deliberation. Moral case deliberation is a structured dialogue between healthcare providers about ethically problematic situations in their daily practice. It has been widely held that frequent moral case deliberation may help healthcare providers to better appreciate moral problems, to learn about their own and others' moral viewpoints, to foster a sense cohesion within their team and to mitigate moral distress (Haan, van Gurp, Naber, \& Groenewoud, 2018). Moral case deliberation may particularly help professionals if it is based on professionals' own objectives in and experiences and expectations of moral case deliberation. It is therefore needed to firmly root moral case deliberation in the ICU practice together with/with the help of ICU-professionals (Weidema, van Dartel, \& Molewijk, 2016). Healthcare professionals themselves are best able to evaluate, learn from and adjust the practice of moral case deliberation on the ICU.
This research sets out to assess the claim that moral case deliberation can help mitigate moral distress among healthcare providers and as such reduce the risk of burnout. It does so by employing Mixed Methods Action Research (MMAR), through which the research will be conducted through and with ICU-professionals, creating co-ownership of moral case deliberation among participants. The study hopes to achieve that, instead of developing burnout as a consequence of moral distress, moral case deliberation will help IC professionals learn from morally distressing situations, potentially leading to cultural an organizational improvement and improvement of quality of care.
Research questions to be answered:
- How does moral distress, as a supposed risk factor for burnout of IC-professionals, relate to other risk factors of burnout, personality, negative work-home interactions and the ICU context?
- How do IC-professionals experience preparation, participation and the impact on daily practice of particular moral case deliberations?
- Does moral case deliberation lead to a reduction of moral distress, burnout and team cohesion?
- How can IC-professionals establish cumulative learning from moral case deliberation throughout their department?
Methods:
Quantitative methods Quantitative methods will be used to assess questions 1 and 3. Survey data will be gathered in a stepped wedge trial. Surveys will be sent to around 450 ICU-professionals which are nested in six ICUs, nested in two hospitals. The data thus has a multilevel structure (individuals in units in hospitals). The study aims for a response rate of 50% or higher, including more than 230 participants. This is expectation is formulated on the basis of the departments' experience of response rates in previous studies done in this population. During the trial, the different ICUs will receive the intervention in a stepwise manner. Within a stepped wedge design, what is randomized is the time point at which a unit receives the intervention. One unit starts in January 2020 and will receive the intervention for the full two years. Two units will start participating as of July 2020 and will then participate until December 2021. In January 2021, two other units will start participating. The last unit will receive the intervention as of July 2021 and participate for the remaining six months.
Survey data will be gathered at five measurement points, after every 6 months, the first being a baseline measurement. The baseline measurement will take place before January 2020, the second measurement will take place before July 2020, the third measurement will take in the months preceding January 2021, the fourth measurement will take place in the months preceding July 2021 and the last measurement will take place in December 2021. The survey consists of validated measurements for burnout syndrome (UBOS-C), moral distress (MDS-R), work-home interaction (SWING), personality (BFI), departmental culture (Culture of Care Barometer) and team cohesion (a set of six questions taken from the Safety Attitudes Questionnaire).
The baseline data will inspire answering research question 1. Hierarchical linear regression analysis will be used to assess the association between several concepts (e.g. moral distress, work-home interaction, personality). With hierarchical regression analysis, the explaining variance of moral distress on burn-out, controlled for burnout risk factors such as work-home interaction and personality, will be analysed. Hierarchical linear regression is a framework for model comparison: several regression models are built by adding variables to previous model at each new step and thus, later models always include the previous smaller models. The question is whether the newly added variable shows a significant improvement in the proportion of explained variance of burnout (the R2).
The survey data gathered at all five measurement points is suited for analysis which allows for assessment of question 3. The data gathered in the stepped wedge design, in which clusters (units) are randomized, is well suited for interrupted time series analysis. Interrupted time series analysis is used to evaluate the effect of an intervention in longitudinal data. The key assumption of interrupted time series analysis of this data is that moral case deliberation, as an intervention, changes the pre-intervention trend of burnout prevalence among ICU-professionals; in other words, it assumes that the pre-intervention trend would continue unchanged into the post-intervention period if there had not been an intervention. Training, as well as the advice of an expert statistician (Steven Teerenstra), will be sought to gain better insight in conducting interrupted time series analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Longitudinal Stepped Wedge cluster randomized Trial with an open cohort
| Arm | Type | Receives |
|---|---|---|
| Intensive care unit 1 | Experimental | Other: Monthly moral case deliberationReceives of intervention consisting of monthly moral case deliberation (ethical decision-making) meetings, planned and set up by ICU professionals which have received the task of being more attentive to ethical situations during work. |
| Intensive care unit 2 | Other | Other: Monthly moral case deliberationFirst non-intervention, then flips to experimental arm type after six months. |
| Intensive care unit 3 | Other | Other: Monthly moral case deliberationFirst non-intervention, then flips to experimental arm type after six months. |
| Intensive care unit 4 | Other | Other: Monthly moral case deliberationFirst non-intervention, then flips to experimental arm type after twelve months. |
| Intensive care unit 5 | Other | Other: Monthly moral case deliberationFirst non-intervention, then flips to experimental arm type after twelve months. |
| Intensive care unit 6 | Other | Other: Monthly moral case deliberationFirst non-intervention, then flips to experimental arm type after Eighteen months. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ICU professionals age 16 years or older working in intensive care departments in the Radboud University Medical Centre or the Canisius Wilhelmina Hospital
- gave written informed consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Monthly moral case deliberationOnce per month, ICU professionals will take part in moral case deliberation. As part of the intervention, two or three ICU professionals (physicians and nurses) are tasked with selecting a case for moral discussion. Moral case deliberation is attended by around thirty individuals per month per unit. A feedback system will be developed used to spread the knowledge/insights from the case deliberation to all professionals in the unit. | Other | Intensive care unit 1, Intensive care unit 2, Intensive care unit 3, Intensive care unit 4, Intensive care unit 5, Intensive care unit 6 |
Primary outcome
Burnout - measured by the Utrecht Burnout Scale (UBOS-C) survey instrument
Time frame: six months
An excessive reaction to stress caused by one's environment that may be Burnout is characterized by feelings of emotional and physical exhaustion, coupled with a sense of frustration and failure. This is measured through the Utrecht Burnout Scale (UBOS-C) survey instrument, a Dutch version of the Maslach Burnout Inventory (MBI), containing 20 items. The MBI measures three dimensions of burnout: emotional exhaustion, depersonalisation and personal accomplishment on 0 to 6 scales. Higher scores on emotional exhaustion and depersonalisation mean a worse outcome, while a higher score on personal accomplishment means a better outcome.
1 secondary outcome
Moral distress - measured by the 21-item moral distress scale (revised version) survey instrument
Time frame: six 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 4 Nov 2022.
- Derived from this study: PubMed 37272981Kok N, Zegers M, Teerenstra S, Fuchs M, van der Hoeven JG, van Gurp JLP, Hoedemaekers CWE. Effect of Structural Moral Case Deliberation on Burnout Symptoms, Moral Distress, and Team Climate in ICU Professionals: A Parallel Cluster Randomized Trial. Crit Care Med. 2023 Oct 1;51(10):1294-1305. doi: 10.1097/CCM.0000000000005940. Epub 2023 Jun 5.
- 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.
Jelle Van Gurp, PhD principal investigator
IQ healthcare, Radboud University medical center
Hans Van der Hoeven, MD, PhD principal investigator
Intensive care, Radboud Univesity medical center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly moral case deliberation in people with Burnout, Professional and Caregiver Exhaustion, run by Radboud University Medical Center at 2 sites in Netherlands.
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 2 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: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Burnout - measured by the Utrecht Burnout Scale (UBOS-C) survey instrument (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04442438, which also lists 1 linked publication.
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 4 Nov 2022.