FirefightersNCT07199387
PeerOnCall: Implementing and Evaluating App-Based Peer Support in Canadian Fire Services
A study testing App Users (Structured Implementation) and App Users (Standard Implementation) in people with Firefighters, run by McMaster University at 1 site in Canada.
Trial summary
The goal of this clinical trial is to test how best to implement a mobile peer support app called PeerOnCall in Canadian fire services. The main questions it aims to answer are: 1. Do firefighters use the app more with a structured implementation compared to standard implementation? 2. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Firefighters
- What is being tested?
- App Users (Structured Implementation) and App Users (Standard Implementation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a working aged adult (18-70)
- Must be employed in a participating Canadian Fire Service organization
- Agree to download the PeerOnCall app to their mobile phone (iPhone or Android)
Who cannot join
- Not able to access app on their smart device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
20 Fire Service Organizations across Canada
Hamilton
Research Coordinator, 5198300626, parkem9@mcmaster.ca
About this study
Official title: PeerOnCall: A Cluster Randomized Trial of a Peer Support Mobile Health Platform in Canadian Fire Service Organizations
The goal of this clinical trial is to test how best to implement a mobile peer support app called PeerOnCall in Canadian fire services. The main questions it aims to answer are:
- Do firefighters use the app more with a structured implementation compared to standard implementation?
- Does using the app improve mental health and workplace outcomes? Researchers will compare a standard implementation approach with basic onboarding to more structured implementation with weekly reminders, new content, and feedback reports to see if these features encourage more consistent app use.
Read more
Participants will:
- Use the PeerOnCall app to access private peer support and wellness resources.
- Participate in surveys, interviews, and focus groups about their app experience and workplace environment.
- Conditions
- Firefighters
- Being tested
- App Users (Structured Implementation), App Users (Standard Implementation)
- Keywords
- Peer Support, Mobile Health Applications, Mental Health, Firefighters, Occupational Health, Workplace Wellbeing, Implementation Science
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App Users (Structured Implementation)Other
The structured implementation (intervention) group will follow a structured protocol designed to promote weekly app engagement. This includes regular updates to customized content, reminders to use the app, and feedback on use. Weekly content updates and push notifications will be provided through the app, and the research team will communicate monthly with organizational champions with feedback reports on app utilization to reinforce engagement.
App Users (Standard Implementation)Other
The standard implementation (control) group will receive baseline support, allowing firefighters to use the app as they choose. The research team will provide an initial orientation for organizations and peer supporters, but the organizational champion will be responsible for communication and follow-up. The research team will respond to questions and prompt data collection.
| Study group | Role | What they receive |
|---|---|---|
| App Users (Structured Implementation) | Experimental | All participating organizations will receive access to PeerOnCall, a mobile mental health and peer support platform co-designed by and for Canadian public safety providers (PSP) that includes: a) an app for frontline workers, b) an app for peer support providers, and c) an administrative portal for organizational leaders. The structured implementation (intervention) group will follow a structured protocol designed to promote weekly app engagement. Receives: Other: App Users (Structured Implementation) |
| App Users (Standard Implementation) | Active comparator | All participating organizations will receive access to PeerOnCall, a mobile mental health and peer support platform co-designed by and for Canadian public safety providers (PSP) that includes: a) an app for frontline workers, b) an app for peer support providers, and c) an administrative portal for organizational leaders. The standard implementation (control) group will receive baseline support, allowing firefighters to use the app as they choose. Receives: Other: App Users (Standard Implementation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Score on the Mental Health Continuum at 1 year
Impact on mental health (primary) outcome - A 10-point visual analogue scale (VAS) will be used to measure mental health status as a continuous variable, aligning with the mental health continuum commonly used in the public safety community. The scale uses color coding from 0 (green/well) to 10 (red/crisis) with strong concurrent validity (r = .60 to .74) compared to other anxiety measures. Pilot research indicated that firefighters are resistant to lengthy psychological questionnaires, so this brief, intuitive, and widely accepted single-item scale was selected to optimize response rates. App users will receive monthly in-app notifications prompting them to complete the scale. Since the scale is integrated into the app, data can be directly linked to app utilization.
Measured: From Baseline to the end of implementation at 1-year
App Engagement (App Opens)
App opens will be tracked as a binary variable, measuring whether an employee opens the app at least once during the 12-month study period. This initial adoption measure will be monitored using unique ID numbers to track the total number of app opens per user. A list of eligible employees will be established at the start of the intervention and monitored over time to assess engagement across the organization.
Measured: From enrolment to the end of implementation at 1-year
App Engagement (Peer Support Outreach)
Peer support outreach will be measured by the number of text or phone interactions initiated with a peer support provider. Software analytics will track individual use patterns, including whether users reach out once or multiple times to peer support. Higher outreach frequency reflects greater engagement with the app.
Measured: From enrolment to the end of implementation at 1-year
Secondary outcomes (2)
Change from Baseline Score on the WLQ-F at 1 year
The secondary outcome is firefighter work performance, measured using the 36-item Work Limitations Questionnaire for Firefighters (WLQ-F), which assesses physical, cognitive, social, emotional, and time-related work demands. Responses are scored on a 5-point Likert scale from 0% (not limited at all) to 100% (unable to do), with higher scores indicating greater limitations.
Measured: From Baseline to the end of implementation at 1-year
Mental Health Absenteeism
Absenteeism, measured as the number of mental health related sick days will also be tracked in each organization. These productivity or performance measures provide important organizational impact data.
Measured: From enrolment to the end of implementation at 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for FirefightersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Moll, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199387
- Sponsor's protocol ID
- 204097
- Other IDs
- 204097
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moll SE, Patten S, Stuart H, MacDermid JC, Kirsh B. Beyond Silence: A Randomized, Parallel-Group Trial Exploring the Impact of Workplace Mental Health Literacy Training with Healthcare Employees. Can J Psychiatry. 2018 Dec;63(12):826-833. doi: 10.1177/0706743718766051. Epub 2018 Apr 19.
PubMed 29673271Lesage FX, Berjot S, Deschamps F. Clinical stress assessment using a visual analogue scale. Occup Med (Lond). 2012 Dec;62(8):600-5. doi: 10.1093/occmed/kqs140. Epub 2012 Sep 10.
PubMed 22965867Dutheil F, Palgen C, Brousse G, Cornet T, Mermillod M, Lakbar I, Vallet G, Baker JS, Schmidt J, Charbotel B, Pereira B, Delamarre L. Validation of visual analog scales of mood and anxiety at the workplace. PLoS One. 2024 Dec 31;19(12):e0316159. doi: 10.1371/journal.pone.0316159. eCollection 2024.
PubMed 39739967Moll SE, Ricciardelli R, Carleton RN, MacDermid JC, Czarnuch S, MacPhee RS. PeerOnCall: Evaluating Implementation of App-Based Peer Support in Canadian Public Safety Organizations. Int J Environ Res Public Health. 2025 Aug 13;22(8):1269. doi: 10.3390/ijerph22081269.
PubMed 40869854Raggi A, Bernard RM, Toppo C, Sabariego C, Salvador Carulla L, Lukersmith S, Hakkaart-van Roijen L, Merecz-Kot D, Olaya B, Antunes Lima R, Gutierrez-Marin D, Vorstenbosch E, Curatoli C, Cacciatore M. The EMPOWER Occupational e-Mental Health Intervention Implementation Checklist to Foster e-Mental Health Interventions in the Workplace: Development Study. J Med Internet Res. 2024 Mar 15;26:e48504. doi: 10.2196/48504.
PubMed 38488846Goraya NK, Alvarez E, Young M, Moll S. PeerOnCall: Exploring how organizational culture shapes implementation of a peer support app for public safety personnel. Compr Psychiatry. 2024 Nov;135:152524. doi: 10.1016/j.comppsych.2024.152524. Epub 2024 Aug 12.
PubMed 39146608Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.
PubMed 36309746Howarth A, Quesada J, Silva J, Judycki S, Mills PR. The impact of digital health interventions on health-related outcomes in the workplace: A systematic review. Digit Health. 2018 May 10;4:2055207618770861. doi: 10.1177/2055207618770861. eCollection 2018 Jan-Dec.
PubMed 29942631Voth M, Chisholm S, Sollid H, Jones C, Smith-MacDonald L, Bremault-Phillips S. Correction: Efficacy, Effectiveness, and Quality of Resilience-Building Mobile Health Apps for Military, Veteran, and Public Safety Personnel Populations: Scoping Literature Review and App Evaluation. JMIR Mhealth Uhealth. 2023 Aug 28;11:e51609. doi: 10.2196/51609.
PubMed 37639713Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Johnson, C. C., Vega, L., Kohalmi, A. L., Roth, J. C., Howell, B. R., & Van Hasselt, V. B. (2020). Enhancing mental health treatment for the firefighter population: Understanding fire culture, treatment barriers, practice implications, and research directions. Professional Psychology: Research and Practice, 51(3), 304-311. https://doi.org/10.1037/pro0000266
Canadian Association of Fire Chiefs (Nov 2024). The State of Fire and Emergency services in Canada: Results of the great Canadian Fire census 2024. Ottawa: CAFC
Carleton, R. N., Afifi, T. O., Turner, S., Taillieu, T., LeBouthillier, D. M., Duranceau, S., Sareen, J., Ricciardelli, R., MacPhee, R. S., Groll, D., Hozempa, K., Brunet, A., Weekes, J. R., Griffiths, C. T., Abrams, K. J., Jones, N. A., Beshai, S., Cramm, H. A., Dobson, K. S., . . . Asmundson, G. J. G. (2018). Suicidal ideation, plans, and attempts among public safety personnel in Canada.Canadian Psychology / Psychologie canadienne, 59(3), 220-231. https://doi.org/10.1037/cap0000136
MacDermid JC, Lomotan M, Hu MA. Canadian Career Firefighters' Mental Health Impacts and Priorities. Int J Environ Res Public Health. 2021 Dec 1;18(23):12666. doi: 10.3390/ijerph182312666.
PubMed 34886394Carleton RN, Afifi TO, Turner S, Taillieu T, Duranceau S, LeBouthillier DM, Sareen J, Ricciardelli R, MacPhee RS, Groll D, Hozempa K, Brunet A, Weekes JR, Griffiths CT, Abrams KJ, Jones NA, Beshai S, Cramm HA, Dobson KS, Hatcher S, Keane TM, Stewart SH, Asmundson GJG. Mental Disorder Symptoms among Public Safety Personnel in Canada. Can J Psychiatry. 2018 Jan;63(1):54-64. doi: 10.1177/0706743717723825. Epub 2017 Aug 28.
PubMed 28845686
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeerOnCall: A Cluster Randomized Trial of a Peer Support Mobile Health Platform in Canadian Fire Service Organizations
- ClinicalTrials.gov ID
- NCT07199387
- Acronym / sponsor ID
- 204097
- Conditions
- Firefighters
- Keywords
- Peer Support, Mobile Health Applications, Mental Health, Firefighters, Occupational Health, Workplace Wellbeing, Implementation Science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test how best to implement a mobile peer support app called PeerOnCall in Canadian fire services. The main questions it aims to answer are:
- Do firefighters use the app more with a structured implementation compared to standard implementation?
- Does using the app improve mental health and workplace outcomes? Researchers will compare a standard implementation approach with basic onboarding to more structured implementation with weekly reminders, new content, and feedback reports to see if these features encourage more consistent app use.
Participants will:
- Use the PeerOnCall app to access private peer support and wellness resources.
- Participate in surveys, interviews, and focus groups about their app experience and workplace environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App Users (Structured Implementation) | Experimental | Other: App Users (Structured Implementation)All participating organizations will receive access to PeerOnCall, a mobile mental health and peer support platform co-designed by and for Canadian public safety providers (PSP) that includes: a) an app for frontline workers, b) an app for peer support providers, and c) an administrative portal for organizational leaders. The structured implementation (intervention) group will follow a structured protocol designed to promote weekly app engagement. |
| App Users (Standard Implementation) | Active comparator | Other: App Users (Standard Implementation)All participating organizations will receive access to PeerOnCall, a mobile mental health and peer support platform co-designed by and for Canadian public safety providers (PSP) that includes: a) an app for frontline workers, b) an app for peer support providers, and c) an administrative portal for organizational leaders. The standard implementation (control) group will receive baseline support, allowing firefighters to use the app as they choose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be a working aged adult (18-70)
- Must be employed in a participating Canadian Fire Service organization
- Agree to download the PeerOnCall app to their mobile phone (iPhone or Android)
Key exclusion criteria (1 listed)
- Not able to access app on their smart device
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 |
|---|---|---|
| App Users (Structured Implementation)The structured implementation (intervention) group will follow a structured protocol designed to promote weekly app engagement. This includes regular updates to customized content, reminders to use the app, and feedback on use. Weekly content updates and push notifications will be provided through the app, and the research team will communicate monthly with organizational champions with feedback reports on app utilization to reinforce engagement. | Other | App Users (Structured Implementation) |
| App Users (Standard Implementation)The standard implementation (control) group will receive baseline support, allowing firefighters to use the app as they choose. The research team will provide an initial orientation for organizations and peer supporters, but the organizational champion will be responsible for communication and follow-up. The research team will respond to questions and prompt data collection. | Other | App Users (Standard Implementation) |
Primary outcome
Change from Baseline Score on the Mental Health Continuum at 1 year
Time frame: From Baseline to the end of implementation at 1-year
Impact on mental health (primary) outcome - A 10-point visual analogue scale (VAS) will be used to measure mental health status as a continuous variable, aligning with the mental health continuum commonly used in the public safety community. The scale uses color coding from 0 (green/well) to 10 (red/crisis) with strong concurrent validity (r = .60 to .74) compared to other anxiety measures. Pilot research indicated that firefighters are resistant to lengthy psychological questionnaires, so this brief, intuitive, and widely accepted single-item scale was selected to optimize response rates. App users will receive monthly in-app notifications prompting them to complete the scale. Since the scale is integrated into the app, data can be directly linked to app utilization.
App Engagement (App Opens)
Time frame: From enrolment to the end of implementation at 1-year
App opens will be tracked as a binary variable, measuring whether an employee opens the app at least once during the 12-month study period. This initial adoption measure will be monitored using unique ID numbers to track the total number of app opens per user. A list of eligible employees will be established at the start of the intervention and monitored over time to assess engagement across the organization.
App Engagement (Peer Support Outreach)
Time frame: From enrolment to the end of implementation at 1-year
Peer support outreach will be measured by the number of text or phone interactions initiated with a peer support provider. Software analytics will track individual use patterns, including whether users reach out once or multiple times to peer support. Higher outreach frequency reflects greater engagement with the app.
2 secondary outcomes
Change from Baseline Score on the WLQ-F at 1 year
Time frame: From Baseline to the end of implementation at 1-year
Mental Health Absenteeism
Time frame: From enrolment to the end of implementation at 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 29673271Moll SE, Patten S, Stuart H, MacDermid JC, Kirsh B. Beyond Silence: A Randomized, Parallel-Group Trial Exploring the Impact of Workplace Mental Health Literacy Training with Healthcare Employees. Can J Psychiatry. 2018 Dec;63(12):826-833. doi: 10.1177/0706743718766051. Epub 2018 Apr 19.
- Background: PubMed 22965867Lesage FX, Berjot S, Deschamps F. Clinical stress assessment using a visual analogue scale. Occup Med (Lond). 2012 Dec;62(8):600-5. doi: 10.1093/occmed/kqs140. Epub 2012 Sep 10.
- Background: PubMed 39739967Dutheil F, Palgen C, Brousse G, Cornet T, Mermillod M, Lakbar I, Vallet G, Baker JS, Schmidt J, Charbotel B, Pereira B, Delamarre L. Validation of visual analog scales of mood and anxiety at the workplace. PLoS One. 2024 Dec 31;19(12):e0316159. doi: 10.1371/journal.pone.0316159. eCollection 2024.
- Background: PubMed 40869854Moll SE, Ricciardelli R, Carleton RN, MacDermid JC, Czarnuch S, MacPhee RS. PeerOnCall: Evaluating Implementation of App-Based Peer Support in Canadian Public Safety Organizations. Int J Environ Res Public Health. 2025 Aug 13;22(8):1269. doi: 10.3390/ijerph22081269.
- Background: PubMed 38488846Raggi A, Bernard RM, Toppo C, Sabariego C, Salvador Carulla L, Lukersmith S, Hakkaart-van Roijen L, Merecz-Kot D, Olaya B, Antunes Lima R, Gutierrez-Marin D, Vorstenbosch E, Curatoli C, Cacciatore M. The EMPOWER Occupational e-Mental Health Intervention Implementation Checklist to Foster e-Mental Health Interventions in the Workplace: Development Study. J Med Internet Res. 2024 Mar 15;26:e48504. doi: 10.2196/48504.
- Background: PubMed 39146608Goraya NK, Alvarez E, Young M, Moll S. PeerOnCall: Exploring how organizational culture shapes implementation of a peer support app for public safety personnel. Compr Psychiatry. 2024 Nov;135:152524. doi: 10.1016/j.comppsych.2024.152524. Epub 2024 Aug 12.
- Background: PubMed 36309746Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.
- Background: PubMed 29942631Howarth A, Quesada J, Silva J, Judycki S, Mills PR. The impact of digital health interventions on health-related outcomes in the workplace: A systematic review. Digit Health. 2018 May 10;4:2055207618770861. doi: 10.1177/2055207618770861. eCollection 2018 Jan-Dec.
- Background: PubMed 37639713Voth M, Chisholm S, Sollid H, Jones C, Smith-MacDonald L, Bremault-Phillips S. Correction: Efficacy, Effectiveness, and Quality of Resilience-Building Mobile Health Apps for Military, Veteran, and Public Safety Personnel Populations: Scoping Literature Review and App Evaluation. JMIR Mhealth Uhealth. 2023 Aug 28;11:e51609. doi: 10.2196/51609.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- BackgroundJohnson, C. C., Vega, L., Kohalmi, A. L., Roth, J. C., Howell, B. R., & Van Hasselt, V. B. (2020). Enhancing mental health treatment for the firefighter population: Understanding fire culture, treatment barriers, practice implications, and research directions. Professional Psychology: Research and Practice, 51(3), 304-311. https://doi.org/10.1037/pro0000266
- BackgroundCanadian Association of Fire Chiefs (Nov 2024). The State of Fire and Emergency services in Canada: Results of the great Canadian Fire census 2024. Ottawa: CAFC
- PeerOnCall Research WebsiteLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App Users (Structured Implementation) and App Users (Standard Implementation) in people with Firefighters, run by McMaster University at 1 site in Canada.
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 3 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: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Co-Principal Investigator (9054672155, molls@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Score on the Mental Health Continuum at 1 year (time frame: From Baseline to the end of implementation at 1-year). The study lists 3 primary outcomes in all. 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 NCT07199387, which also lists 15 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 3 Oct 2025.