Pollution; ExposureNCT03552198
Improving the Behavioural Impact of Air Quality Alerts
A study testing Alternative health advice in people with Pollution; Exposure and Health Behavior, run by King's College London at 1 site in United Kingdom.
Trial summary
The evidence shows that adherence to air quality advice to adopt protective behaviours during pollution episodes is suboptimal, and that the traditional strategy of simply informing people about high pollution episodes is not effective. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pollution; Exposure, Health Behavior
- What is being tested?
- Alternative health advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jul 2017to 8 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible to participate, participants had to be members of the general public in the adult age range (>18 years), be fluent in English, working or living in Greater London, and being new or old users of a specific air quality alert smartphone application.
Who cannot join
- younger than 18 years
- not working or living in Greater London
- no longer users of the air quality alert smartphone application.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Behavioural Impact of Air Quality Alerts in London
The evidence shows that adherence to air quality advice to adopt protective behaviours during pollution episodes is suboptimal, and that the traditional strategy of simply informing people about high pollution episodes is not effective. The aim of the present study was to investigate how to improve the behavioural impact of existing air quality alert messages through a systematic manipulation of key communication variables, including perceived susceptibility, self-efficacy, response efficacy, planning, message specificity, etc. Users of an existing air quality alert smartphone application in London, who agreed to take part in the study, were randomly allocated to a control group (i.e. receiving usual health advice associated with the official UK Air Quality Index) or an intervention group receiving health advice associated with air quality alerts in an alternative format (i.e. targeting key variables). Both intended and actual adherence behaviours were investigated. Qualitative data were also collected to understand the reasons for not adopting protective behaviours in response to receiving a real air pollution alert.
Implications of this study include the potential to increase protective behaviours in the general population during air pollution episodes through the development of more effective communication strategies provided via existent air quality alert systems.
Read the detailed description
According to data released in 2014, in 2012 around 3.7 million people died prematurely in the world as a result of exposure to ambient air pollution ((WHO), 2014). Evidence has shown the negative short- and long-term effects of air pollution on both premature mortality and morbidity from cardiopulmonary disease (for an overview, see (Kelly \& Fussell, 2015)). This is particularly a problem in London (Samoli et al., 2016), where levels of air pollution are quite worrying. In the UK monitoring networks measure the levels of different air pollutants, and these measurements are provided by the Department for Environment, Food \& Rural Affairs (DEFRA) in the form of daily air quality indices (AQIs), together with separate health advice for at-risk groups and the general population. A recently published systematic review (D'Antoni, Smith, Auyeung, \& Weinman, 2017) has found suboptimal adherence levels to health advice associated with air quality alerts, and identified several facilitators and barriers of adherence. Some of the facilitators included beliefs that air pollution can have negative health effects (i.e. perceived severity), outcome expectancies (e.g., beliefs that something can be done to reduce smog), beliefs about the health benefits of AQI adoption (i.e. response efficacy), and receiving advice from health care professionals. Barriers to adherence included: lack of understanding of the indices, being exposed to health messages that reduced both concern about air pollution and perceived susceptibility, as well as perceived lack of self-efficacy/locus of control, reliance on sensory cues and lack of time to make behavioural changes. The findings of this systematic review have informed the current research study, which aimed to improve the behavioural impact of existing air quality alerts. In particular, alternative health messages were developed based on the psychosocial factors identified in the systematic review. The purpose of the study was to test whether these theory and evidence-based alternative communication formats, compared to the official messages sent in association with the UK AQIs, maximise the behavioural impact of existing alert systems.
Methods
Design:
This was a randomised control trail using a 2-way factorial design, with target population (2 levels: general population vs. individuals with a pre-existing health condition) and message format (2 levels: usual message format vs. alternative format) as between-factors. Qualitative data were also collected to understand the reasons for actual adherence and non-adherence.
- Theoretical framework and targeted psychosocial predictors:
The COM-B model (Michie, van Stralen, \& West, 2011) was used as a theoretical framework to guide in the understanding of the facilitators and barriers to behaviour change in response to air quality alerts. The control groups received usual air quality alerts and health advice based on the UK AQI messages, and the intervention groups received alternative health messages targeting knowledge about the health impact of exposure to air pollution, perceived severity of air pollution, perceived susceptibility, perceived efficacy of protective behaviours, self-efficacy, perceived negative consequences associated with protective behaviours, reliance on sensory cue, and action planning. In addition, study participants who reported having a pre-existent respiratory condition and who were randomly allocated in the intervention group, also received specific additional messages targeting beliefs about efficacy and side effects of inhalers, and medication self-efficacy.
- Targeting message specificity:
Specificity refers to the extent to which a message provides a detailed description of the recommended behaviour. A meta-analysis of 18 studies (O'Keefe, 1997) found that messages providing health recommendations with a more specific description seem to be significantly more persuasive than generic recommendations (r=.10, k=18, N=11,105). Participants in the control group received the usual UK AQI message format containing less specific recommendations (e.g. advice for at risk individuals in case of high air pollution: 'Adults and children with lung problems, and adults with heart problems, should reduce strenuous physical exertion, particularly outdoors'). On the other hand, the intervention group received more specific recommendations ('Adults and children with lung problems, adults with heart problems, and older people, should reduce levels and length of physical activity outdoors. Where possible, change: travel route or exercise location (e.g. use our app to find less polluted roads or parks) or time (e.g. mornings or less polluted times)').
Control and intervention groups were compared in intended and actual behaviour change outcome measures. We predicted that the alternative format would be associated with higher behaviour change, compared to the usual format.
- Conditions
- Pollution; Exposure, Health Behavior
- Being tested
- Alternative health advice
- Keywords
- Air quality alerts, Health behaviour change, Adherence
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative health adviceBehavioural
These messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations.
| Study group | Role | What they receive |
|---|---|---|
| General public/usual health advice | No intervention | Healthy participants with a self-reported existing health condition were randomised to receive the usual UK Air Quality Indices health advice. |
| General public/alternative health advice | Experimental | Generally healthy participants were randomised to receive targeted health advice about the adoption of protective behaviours in an alternative format. Receives: Behavioral: Alternative health advice |
| At risk group/usual health advice | No intervention | Participants with a self-reported pre-existing health condition were randomised to receive the usual UK Air Quality Indices health advice. |
| At risk group/alternative health advice | Experimental | Participants with a self-reported existing health conditions were randomised to receive targeted health advice (based on their health condition) about the adoption of protective behaviours in an alternative format. Receives: Behavioral: Alternative health advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of Protective Behaviour at 4 Weeks
Differences between conditions in actual adoption of protective behaviours at 4 weeks. Outcome measures were collected via self-reports: The question was: 'In the past 4 weeks, how often have you taken action to reduce exposure to air pollution, in response to hearing or reading an air quality forecast?' Measures: from 1 'Not at all' to 9 'all of the time' (answers 'N/A, I am not aware of any forecast' were excluded from analyses).
Measured: Baseline and at 4 weeks
Secondary outcomes (3)
Considered Making Permanent Changes
Differences between conditions in planning the adoption of protective behaviours at 4 weeks. Outcome measures were collected via self-reports: The question was: 'In the past 4 weeks, have you considered making permanent changes to daily travel route or exercise location/time?' possible answers were 'yes' or 'no'. 'unsure' answers were treated as system missing.
Measured: at 4 weeks
Actual Behaviour Change in Response to a Real Air Quality Alert
Differences between conditions in self-reported actual behaviour change in response to receiving a real air quality alert. Behavioural outcomes were collected via a questionnaire asking participants to respond 'yes/no' to whether they had changed a series of behaviours in response to receiving the alert. In this case it was a 'moderate' alert
Measured: At 3 weeks
Intentions to Adhere to Health Advice Associated With a Hypothetical High Air Pollution Scenario
Differences between conditions in intentions to adhere to the health advice received in association with a hypothetical high air pollution alert scenario. Intentions were measured by a self-report item: participants were asked to agree with a statement about their adherence intentions on 9-point scale, where 1=strongly disagree to 9=strongly agree.
Measured: Baseline and at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start23 Jul 2017
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pollution; ExposureStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Factorial
- Model description
- This was a randomised control trail using a 2-way factorial design, with target population (2 levels: general population vs. individuals with a pre-existing health condition) and message format (2 levels: usual message format vs. alternative format) as between-factors.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Public Health England
- Responsible party
- Sponsor
- Investigators
- Donatella D'Antoni, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552198
- Sponsor's protocol ID
- LRS-16/17-4286
- Status last verified
- May 2018
- First submitted
- 15 May 2018
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
(WHO), W. H. O. (2014). Burden of disease from air pollution. Retrieved from http://www.who.int/phe/health_topics/outdoorair/databases/FINAL_HAP_AAP_BoD_24March2014.pdf?ua=1.
D'Antoni D, Smith L, Auyeung V, Weinman J. Psychosocial and demographic predictors of adherence and non-adherence to health advice accompanying air quality warning systems: a systematic review. Environ Health. 2017 Sep 22;16(1):100. doi: 10.1186/s12940-017-0307-4.
PubMed 28938911Kelly FJ, Fussell JC. Air pollution and public health: emerging hazards and improved understanding of risk. Environ Geochem Health. 2015 Aug;37(4):631-49. doi: 10.1007/s10653-015-9720-1. Epub 2015 Jun 4.
PubMed 26040976Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
PubMed 21513547Daniel J. O'Keefe (1997) Standpoint Explicitness and Persuasive Effect: A Meta-Analytic Review of the Effects of Varying Conclusion Articulation in Persuasive Messages, Argumentation and Advocacy, 34:1, 1-12, DOI: 10.1080/00028533.1997.11978023
Samoli E, Atkinson RW, Analitis A, Fuller GW, Green DC, Mudway I, Anderson HR, Kelly FJ. Associations of short-term exposure to traffic-related air pollution with cardiovascular and respiratory hospital admissions in London, UK. Occup Environ Med. 2016 May;73(5):300-7. doi: 10.1136/oemed-2015-103136. Epub 2016 Feb 16.
PubMed 26884048
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Behavioural Impact of Air Quality Alerts in London
- ClinicalTrials.gov ID
- NCT03552198
- Acronym / sponsor ID
- LRS-16/17-4286
- Conditions
- Pollution; Exposure, Health Behavior
- Keywords
- Air quality alerts, Health behaviour change, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Public Health England
- Study start
- 23 Jul 2017 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The evidence shows that adherence to air quality advice to adopt protective behaviours during pollution episodes is suboptimal, and that the traditional strategy of simply informing people about high pollution episodes is not effective. The aim of the present study was to investigate how to improve the behavioural impact of existing air quality alert messages through a systematic manipulation of key communication variables, including perceived susceptibility, self-efficacy, response efficacy, planning, message specificity, etc. Users of an existing air quality alert smartphone application in London, who agreed to take part in the study, were randomly allocated to a control group (i.e. receiving usual health advice associated with the official UK Air Quality Index) or an intervention group receiving health advice associated with air quality alerts in an alternative format (i.e. targeting key variables). Both intended and actual adherence behaviours were investigated. Qualitative data were also collected to understand the reasons for not adopting protective behaviours in response to receiving a real air pollution alert.
Implications of this study include the potential to increase protective behaviours in the general population during air pollution episodes through the development of more effective communication strategies provided via existent air quality alert systems.
Detailed description
According to data released in 2014, in 2012 around 3.7 million people died prematurely in the world as a result of exposure to ambient air pollution ((WHO), 2014). Evidence has shown the negative short- and long-term effects of air pollution on both premature mortality and morbidity from cardiopulmonary disease (for an overview, see (Kelly \& Fussell, 2015)). This is particularly a problem in London (Samoli et al., 2016), where levels of air pollution are quite worrying. In the UK monitoring networks measure the levels of different air pollutants, and these measurements are provided by the Department for Environment, Food \& Rural Affairs (DEFRA) in the form of daily air quality indices (AQIs), together with separate health advice for at-risk groups and the general population. A recently published systematic review (D'Antoni, Smith, Auyeung, \& Weinman, 2017) has found suboptimal adherence levels to health advice associated with air quality alerts, and identified several facilitators and barriers of adherence. Some of the facilitators included beliefs that air pollution can have negative health effects (i.e. perceived severity), outcome expectancies (e.g., beliefs that something can be done to reduce smog), beliefs about the health benefits of AQI adoption (i.e. response efficacy), and receiving advice from health care professionals. Barriers to adherence included: lack of understanding of the indices, being exposed to health messages that reduced both concern about air pollution and perceived susceptibility, as well as perceived lack of self-efficacy/locus of control, reliance on sensory cues and lack of time to make behavioural changes. The findings of this systematic review have informed the current research study, which aimed to improve the behavioural impact of existing air quality alerts. In particular, alternative health messages were developed based on the psychosocial factors identified in the systematic review. The purpose of the study was to test whether these theory and evidence-based alternative communication formats, compared to the official messages sent in association with the UK AQIs, maximise the behavioural impact of existing alert systems.
Methods
Design:
This was a randomised control trail using a 2-way factorial design, with target population (2 levels: general population vs. individuals with a pre-existing health condition) and message format (2 levels: usual message format vs. alternative format) as between-factors. Qualitative data were also collected to understand the reasons for actual adherence and non-adherence.
- Theoretical framework and targeted psychosocial predictors:
The COM-B model (Michie, van Stralen, \& West, 2011) was used as a theoretical framework to guide in the understanding of the facilitators and barriers to behaviour change in response to air quality alerts. The control groups received usual air quality alerts and health advice based on the UK AQI messages, and the intervention groups received alternative health messages targeting knowledge about the health impact of exposure to air pollution, perceived severity of air pollution, perceived susceptibility, perceived efficacy of protective behaviours, self-efficacy, perceived negative consequences associated with protective behaviours, reliance on sensory cue, and action planning. In addition, study participants who reported having a pre-existent respiratory condition and who were randomly allocated in the intervention group, also received specific additional messages targeting beliefs about efficacy and side effects of inhalers, and medication self-efficacy.
- Targeting message specificity:
Specificity refers to the extent to which a message provides a detailed description of the recommended behaviour. A meta-analysis of 18 studies (O'Keefe, 1997) found that messages providing health recommendations with a more specific description seem to be significantly more persuasive than generic recommendations (r=.10, k=18, N=11,105). Participants in the control group received the usual UK AQI message format containing less specific recommendations (e.g. advice for at risk individuals in case of high air pollution: 'Adults and children with lung problems, and adults with heart problems, should reduce strenuous physical exertion, particularly outdoors'). On the other hand, the intervention group received more specific recommendations ('Adults and children with lung problems, adults with heart problems, and older people, should reduce levels and length of physical activity outdoors. Where possible, change: travel route or exercise location (e.g. use our app to find less polluted roads or parks) or time (e.g. mornings or less polluted times)').
Control and intervention groups were compared in intended and actual behaviour change outcome measures. We predicted that the alternative format would be associated with higher behaviour change, compared to the usual format.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This was a randomised control trail using a 2-way factorial design, with target population (2 levels: general population vs. individuals with a pre-existing health condition) and message format (2 levels: usual message format vs. alternative format) as between-factors.
| Arm | Type | Receives |
|---|---|---|
| General public/usual health advice | No intervention | –Healthy participants with a self-reported existing health condition were randomised to receive the usual UK Air Quality Indices health advice. |
| General public/alternative health advice | Experimental | Behavioral: Alternative health adviceGenerally healthy participants were randomised to receive targeted health advice about the adoption of protective behaviours in an alternative format. |
| At risk group/usual health advice | No intervention | –Participants with a self-reported pre-existing health condition were randomised to receive the usual UK Air Quality Indices health advice. |
| At risk group/alternative health advice | Experimental | Behavioral: Alternative health adviceParticipants with a self-reported existing health conditions were randomised to receive targeted health advice (based on their health condition) about the adoption of protective behaviours in an alternative format. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible to participate, participants had to be members of the general public in the adult age range (>18 years), be fluent in English, working or living in Greater London, and being new or old users of a specific air quality alert smartphone application.
Key exclusion criteria (3 listed)
- younger than 18 years
- not working or living in Greater London
- no longer users of the air quality alert smartphone application.
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 |
|---|---|---|
| Alternative health adviceThese messages targeted specific beliefs about air pollution and protective actions aimed at reducing exposure to air pollution. In addition, message specificity was targeted, which means that compared to the usual messages, the alternative messages reported more detailed health recommendations. | Behavioural | At risk group/alternative health advice, General public/alternative health advice |
Primary outcome
Adoption of Protective Behaviour at 4 Weeks
Time frame: Baseline and at 4 weeks
Differences between conditions in actual adoption of protective behaviours at 4 weeks. Outcome measures were collected via self-reports: The question was: 'In the past 4 weeks, how often have you taken action to reduce exposure to air pollution, in response to hearing or reading an air quality forecast?' Measures: from 1 'Not at all' to 9 'all of the time' (answers 'N/A, I am not aware of any forecast' were excluded from analyses).
3 secondary outcomes
Considered Making Permanent Changes
Time frame: at 4 weeks
Actual Behaviour Change in Response to a Real Air Quality Alert
Time frame: At 3 weeks
Intentions to Adhere to Health Advice Associated With a Hypothetical High Air Pollution Scenario
Time frame: Baseline and at 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background(WHO), W. H. O. (2014). Burden of disease from air pollution. Retrieved from http://www.who.int/phe/health_topics/outdoorair/databases/FINAL_HAP_AAP_BoD_24March2014.pdf?ua=1.
- Background: PubMed 28938911D'Antoni D, Smith L, Auyeung V, Weinman J. Psychosocial and demographic predictors of adherence and non-adherence to health advice accompanying air quality warning systems: a systematic review. Environ Health. 2017 Sep 22;16(1):100. doi: 10.1186/s12940-017-0307-4.
- Background: PubMed 26040976Kelly FJ, Fussell JC. Air pollution and public health: emerging hazards and improved understanding of risk. Environ Geochem Health. 2015 Aug;37(4):631-49. doi: 10.1007/s10653-015-9720-1. Epub 2015 Jun 4.
- Background: PubMed 21513547Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- BackgroundDaniel J. O'Keefe (1997) Standpoint Explicitness and Persuasive Effect: A Meta-Analytic Review of the Effects of Varying Conclusion Articulation in Persuasive Messages, Argumentation and Advocacy, 34:1, 1-12, DOI: 10.1080/00028533.1997.11978023
- Background: PubMed 26884048Samoli E, Atkinson RW, Analitis A, Fuller GW, Green DC, Mudway I, Anderson HR, Kelly FJ. Associations of short-term exposure to traffic-related air pollution with cardiovascular and respiratory hospital admissions in London, UK. Occup Environ Med. 2016 May;73(5):300-7. doi: 10.1136/oemed-2015-103136. Epub 2016 Feb 16.
- 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.
Donatella D'Antoni principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternative health advice in people with Pollution; Exposure and Health Behavior, run by King's College London at 1 site in United Kingdom.
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 1 inclusion and 3 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 22 Oct 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adoption of Protective Behaviour at 4 Weeks (time frame: Baseline and at 4 weeks). 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 NCT03552198, which also lists 6 linked publications.
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 22 Oct 2021.