Covid19 VaccinationNCT05099497
Supporting Audit and Feedback to Encourage Vaccine Uptake
A study testing Using Practice Facilitators to Support Physicians in people with Covid19 Vaccination and Vaccine Uptake, run by Women's College Hospital at 1 site in Canada.
Trial summary
In Ontario, approximately 6,000 family physicians can access a secure online system that provides a report that lists the COVID-19 vaccination status for each patient in their roster. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19 Vaccination, Vaccine Uptake
- What is being tested?
- Using Practice Facilitators to Support Physicians
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2021to 15 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 6,690 family physicians across Ontario who have active (up-to-date passwords) ONE ID accounts
Who cannot join
- family physicians across Ontario who do not have an active ONE ID account
- family physicians with less than 300 rostered patients
- family physicians with more than 3000 rostered patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Big Data and Little Behaviours: Feedback and Quality Improvement Supports to Primary Care to Facilitate COVID-19 Vaccine Uptake
In Ontario, approximately 6,000 family physicians can access a secure online system that provides a report that lists the COVID-19 vaccination status for each patient in their roster.
This implementation trial tests a practice facilitation intervention that aims to support family physicians to access their vaccination reports and effectively communicate with their unvaccinated patients. The facilitator will help develop action plans and offer a range of options, including co-hosted online town-halls, support for medical office assistants to coordinate patient outreach, and/or connection to trained, volunteer medical students that can help with patient outreach.
Read the detailed description
Our goal is to provide additional resources for family physicians who most need support to effectively engage with unvaccinated patients. Specifically, practice facilitators will use participatory methods incorporating lessons from change management and quality improvement methodology.
Our practice facilitators will help physicians by:
- Providing technical support to access their vaccination report (or activating a delegate to do so), and to prepare a complete list of their patients that still need to be vaccinated with available contact information.
- Helping develop an outreach plan with their administrative staff. Outreach can include bulk emails, text messages, phone call, or an invitation to a townhall. They will provide advice and resources for family physicians and their staff in responding to vaccine-related questions. Every eligible physician (i.e., those with access to a vaccine list) in a given practice location will be able to benefit from the support of the practice facilitator.
- The physicians will also be offered the help of a medical student volunteer to assist with patient engagement. Under the Health Insurance Portability and Accountability Act (HIPAA), Physicians, as the acting health information custodian, can legally assign a custodian to do something on their behalf. The medical student volunteer will enter into a non-disclosure agreement (NDA) to ensure the patient's privacy and confidentiality of vaccination status. The medical student volunteer can help with patient engagement and offer support to family physicians who might not have the time to personally contact those patients who have yet to receive both doses of the COVID-19 vaccine. The medical student volunteers will be provided with a script for making telephone calls and training in Private Health Information, refraining from providing medical advice and the importance of confidentiality. They will also be provided with a list of common questions to address when contacting patients regarding COVID-19 vaccination and resources on how to engage in conversation with individuals who are vaccine hesitant.. A few topics provided to the medical student volunteer prior to contacting patients will include making the case for vaccination, finding out patient concerns, how to counter common vaccine concerns (speed of vaccine development, safety, side effects, misinformation, distrust of science, government and medical community, underlying conditions that can increase vulnerability to vaccine side effects) and why vaccination matters. According to the Canadian Medical Protective Association (CMPA), the medical student will be covered under the insurance of the physician as long as the physician provides permission to contact the patient. The medical student must also record the interaction using the call log datasheet provided by the research team and send this information back to the Family Physicians to be included in their EMR. A call log form will be provided for every volunteer to track their calls and the patients who were contacted.
- Physicians will also be invited to co-host in a townhall with their unvaccinated patients. Each physician will have the opportunity to organize one town hall for their patients. The facilitator and our research staff will support these town halls, including a template slide deck, and customizable promotional material, all developed in partnership with the Health Commons Solutions Lab. Family physicians will take part in the session so they can address any clinical questions. The family physician will be offered a stipend for their time involved in inviting unvaccinated patients to the sessions and participation. Following the webinar, family physicians will be supported to send targeted letters to each of their as-yet-unvaccinated patients with action plans and supportive materials. Physicians working in communities with community ambassadors (i.e. a lay health advisor) will also have opportunity to include a community ambassador in their town hall. Community ambassadors can co-host the townhall and play an integral piece as they have connections with the community and understand the context and their struggles.
- Conditions
- Covid19 Vaccination, Vaccine Uptake
- Being tested
- Using Practice Facilitators to Support Physicians
- Keywords
- Covid19, Vaccine Uptake, Vaccine Hesitancy, Vaccine Confidence, Community Outreach, Audit and Feedback
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Practice Facilitators to Support PhysiciansOther
Utilize practice facilitators to empower family physicians to contact those who remain unvaccinated have better access to the COVID-19 vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Practice facilitation and additional support | Experimental | Ontario Health will send out letters to physicians in the intervention group that will explain to them that they have a large group of eligible and unvaccinated patients and that an initiative is planned to support them in reaching out to those patients, with an embedded evaluation. It will ask them to reach out to the research team to plan a time to access the supports to gather more information, or to opt-out from the evaluation. Specifically, physicians will receive invitations to receive practice facilitation via mail letter and fax, followed by up to five weekly phone calls from a team member at Ontario Health. Receives: Other: Using Practice Facilitators to Support Physicians |
| Control group- No intervention | No intervention | We choose to include a control group as we do not have the resources to deliver the intervention to the entire physician group. Cluster randomization by primary practice address will limit contamination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any vaccine dose during follow-up interval
Count of vaccine doses among rostered patients 12+/100 patients
Measured: approximately 4 months (from time of randomization until follow-up completed end of fiscal year, March 31, 2022)
Secondary outcomes (4)
1st vaccine dose during follow-up interval
patients 12+ eligible not yet vaccinated and received first dose during follow-up interval
Measured: 4 months
2nd vaccine dose during follow-up interval
Second vaccine doses among rostered patients 12+ during follow-up interval
Measured: 4 months
3rd vaccine dose during follow-up interval
Third (booster) doses among rostered patients 12+ during follow-up interval
Measured: 4 months
Pediatric dose during follow-up interval
Vaccine doses among rostered patients aged 5-11 during follow-up interval
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start15 Nov 2021
- Primary completion15 Mar 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Covid19 VaccinationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized-control trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Health, Institute for Clinical Evaluative Sciences
- Responsible party
- Sponsor
- Investigators
- Noah Ivers, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099497
- Sponsor's protocol ID
- 2021-0082-E
- Status last verified
- Apr 2024
- First submitted
- 5 Oct 2021
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data analysis will take place at the Institute for Clinical Evaluative Sciences (ICES). Ontario Health will provide ICES with a list of physicians that were in either the control or intervention group. This list will be transferred to ICES using a secure portal process (axway). Data will be captured from administrative databases (including COVaxON registry data) held at ICES. Data will be linked at the physician level using their encrypted CPSO (College of Physicians and Surgeons of Ontario) number.
Publications
Jarrett C, Wilson R, O'Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy. Strategies for addressing vaccine hesitancy - A systematic review. Vaccine. 2015 Aug 14;33(34):4180-90. doi: 10.1016/j.vaccine.2015.04.040. Epub 2015 Apr 18.
PubMed 25896377COVID19Tracker.ca: Ontario Vaccination Data, 2021
Semeniuk I: How many COVID-19 vaccine doses could make the difference between a fourth wave in Canada and no wave at all? New models offer four scenarios, The Globe and Mail, 2021
Gilkey MB, Calo WA, Moss JL, Shah PD, Marciniak MW, Brewer NT. Provider communication and HPV vaccination: The impact of recommendation quality. Vaccine. 2016 Feb 24;34(9):1187-92. doi: 10.1016/j.vaccine.2016.01.023. Epub 2016 Jan 24.
PubMed 26812078Lu PJ, Yankey D, Fredua B, O'Halloran AC, Williams C, Markowitz LE, Elam-Evans LD. Association of Provider Recommendation and Human Papillomavirus Vaccination Initiation among Male Adolescents Aged 13-17 Years-United States. J Pediatr. 2019 Mar;206:33-41.e1. doi: 10.1016/j.jpeds.2018.10.034. Epub 2018 Nov 15.
PubMed 30448270Cataldi JR, Kerns ME, O'Leary ST. Evidence-based strategies to increase vaccination uptake: a review. Curr Opin Pediatr. 2020 Feb;32(1):151-159. doi: 10.1097/MOP.0000000000000843.
PubMed 31790027Dahrouge S, Glazier R, Hogg W: Defining measures of panel size. Primary health care system (PHCS) Program, 2010
Ontario College of Family Physicians: With Vaccines Coming, Family Doctors Could Jab Millions More If Fully Involved, 2021
Anderson EL. Recommended solutions to the barriers to immunization in children and adults. Mo Med. 2014 Jul-Aug;111(4):344-8.
PubMed 25211867SAGE Working Group: Report of the SAGE working group on vaccine hesitancy. Geneva: World Health Organization, 2014
Briss PA, Rodewald LE, Hinman AR, Shefer AM, Strikas RA, Bernier RR, Carande-Kulis VG, Yusuf HR, Ndiaye SM, Williams SM. Reviews of evidence regarding interventions to improve vaccination coverage in children, adolescents, and adults. The Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):97-140. doi: 10.1016/s0749-3797(99)00118-x.
PubMed 10806982Fu LY, Zimet GD, Latkin CA, Joseph JG. Associations of trust and healthcare provider advice with HPV vaccine acceptance among African American parents. Vaccine. 2017 Feb 1;35(5):802-807. doi: 10.1016/j.vaccine.2016.12.045. Epub 2017 Jan 4.
PubMed 28063706BeWORKS Research Group: COVID-19 Vaccine Hesitancy: A Behavioural Lens on a Critical Problem, 2021
Dube E, Gagnon D, MacDonald NE; SAGE Working Group on Vaccine Hesitancy. Strategies intended to address vaccine hesitancy: Review of published reviews. Vaccine. 2015 Aug 14;33(34):4191-203. doi: 10.1016/j.vaccine.2015.04.041. Epub 2015 Apr 18.
PubMed 25896385Lau R, Stevenson F, Ong BN, Dziedzic K, Treweek S, Eldridge S, Everitt H, Kennedy A, Qureshi N, Rogers A, Peacock R, Murray E. Achieving change in primary care--effectiveness of strategies for improving implementation of complex interventions: systematic review of reviews. BMJ Open. 2015 Dec 23;5(12):e009993. doi: 10.1136/bmjopen-2015-009993.
PubMed 26700290
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Big Data and Little Behaviours: Feedback and Quality Improvement Supports to Primary Care to Facilitate COVID-19 Vaccine Uptake
- ClinicalTrials.gov ID
- NCT05099497
- Acronym / sponsor ID
- 2021-0082-E
- Conditions
- Covid19 Vaccination, Vaccine Uptake
- Keywords
- Covid19, Vaccine Uptake, Vaccine Hesitancy, Vaccine Confidence, Community Outreach, Audit and Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Ontario Health, Institute for Clinical Evaluative Sciences
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 29 Oct 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.
In Ontario, approximately 6,000 family physicians can access a secure online system that provides a report that lists the COVID-19 vaccination status for each patient in their roster.
This implementation trial tests a practice facilitation intervention that aims to support family physicians to access their vaccination reports and effectively communicate with their unvaccinated patients. The facilitator will help develop action plans and offer a range of options, including co-hosted online town-halls, support for medical office assistants to coordinate patient outreach, and/or connection to trained, volunteer medical students that can help with patient outreach.
Detailed description
Our goal is to provide additional resources for family physicians who most need support to effectively engage with unvaccinated patients. Specifically, practice facilitators will use participatory methods incorporating lessons from change management and quality improvement methodology.
Our practice facilitators will help physicians by:
- Providing technical support to access their vaccination report (or activating a delegate to do so), and to prepare a complete list of their patients that still need to be vaccinated with available contact information.
- Helping develop an outreach plan with their administrative staff. Outreach can include bulk emails, text messages, phone call, or an invitation to a townhall. They will provide advice and resources for family physicians and their staff in responding to vaccine-related questions. Every eligible physician (i.e., those with access to a vaccine list) in a given practice location will be able to benefit from the support of the practice facilitator.
- The physicians will also be offered the help of a medical student volunteer to assist with patient engagement. Under the Health Insurance Portability and Accountability Act (HIPAA), Physicians, as the acting health information custodian, can legally assign a custodian to do something on their behalf. The medical student volunteer will enter into a non-disclosure agreement (NDA) to ensure the patient's privacy and confidentiality of vaccination status. The medical student volunteer can help with patient engagement and offer support to family physicians who might not have the time to personally contact those patients who have yet to receive both doses of the COVID-19 vaccine. The medical student volunteers will be provided with a script for making telephone calls and training in Private Health Information, refraining from providing medical advice and the importance of confidentiality. They will also be provided with a list of common questions to address when contacting patients regarding COVID-19 vaccination and resources on how to engage in conversation with individuals who are vaccine hesitant.. A few topics provided to the medical student volunteer prior to contacting patients will include making the case for vaccination, finding out patient concerns, how to counter common vaccine concerns (speed of vaccine development, safety, side effects, misinformation, distrust of science, government and medical community, underlying conditions that can increase vulnerability to vaccine side effects) and why vaccination matters. According to the Canadian Medical Protective Association (CMPA), the medical student will be covered under the insurance of the physician as long as the physician provides permission to contact the patient. The medical student must also record the interaction using the call log datasheet provided by the research team and send this information back to the Family Physicians to be included in their EMR. A call log form will be provided for every volunteer to track their calls and the patients who were contacted.
- Physicians will also be invited to co-host in a townhall with their unvaccinated patients. Each physician will have the opportunity to organize one town hall for their patients. The facilitator and our research staff will support these town halls, including a template slide deck, and customizable promotional material, all developed in partnership with the Health Commons Solutions Lab. Family physicians will take part in the session so they can address any clinical questions. The family physician will be offered a stipend for their time involved in inviting unvaccinated patients to the sessions and participation. Following the webinar, family physicians will be supported to send targeted letters to each of their as-yet-unvaccinated patients with action plans and supportive materials. Physicians working in communities with community ambassadors (i.e. a lay health advisor) will also have opportunity to include a community ambassador in their town hall. Community ambassadors can co-host the townhall and play an integral piece as they have connections with the community and understand the context and their struggles.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Cluster randomized-control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Practice facilitation and additional support | Experimental | Other: Using Practice Facilitators to Support PhysiciansOntario Health will send out letters to physicians in the intervention group that will explain to them that they have a large group of eligible and unvaccinated patients and that an initiative is planned to support them in reaching out to those patients, with an embedded evaluation. It will ask them to reach out to the research team to plan a time to access the supports to gather more information, or to opt-out from the evaluation. Specifically, physicians will receive invitations to receive practice facilitation via mail letter and fax, followed by up to five weekly phone calls from a team member at Ontario Health. |
| Control group- No intervention | No intervention | –We choose to include a control group as we do not have the resources to deliver the intervention to the entire physician group. Cluster randomization by primary practice address will limit contamination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 6,690 family physicians across Ontario who have active (up-to-date passwords) ONE ID accounts
Key exclusion criteria (3 listed)
- family physicians across Ontario who do not have an active ONE ID account
- family physicians with less than 300 rostered patients
- family physicians with more than 3000 rostered patients
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 |
|---|---|---|
| Using Practice Facilitators to Support PhysiciansUtilize practice facilitators to empower family physicians to contact those who remain unvaccinated have better access to the COVID-19 vaccine. | Other | Intervention group: Practice facilitation and additional support |
Primary outcome
Any vaccine dose during follow-up interval
Time frame: approximately 4 months (from time of randomization until follow-up completed end of fiscal year, March 31, 2022)
Count of vaccine doses among rostered patients 12+/100 patients
4 secondary outcomes
1st vaccine dose during follow-up interval
Time frame: 4 months
2nd vaccine dose during follow-up interval
Time frame: 4 months
3rd vaccine dose during follow-up interval
Time frame: 4 months
Pediatric dose during follow-up interval
Time frame: 4 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 24 Apr 2024.
- Background: PubMed 25896377Jarrett C, Wilson R, O'Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy. Strategies for addressing vaccine hesitancy - A systematic review. Vaccine. 2015 Aug 14;33(34):4180-90. doi: 10.1016/j.vaccine.2015.04.040. Epub 2015 Apr 18.
- BackgroundCOVID19Tracker.ca: Ontario Vaccination Data, 2021
- BackgroundSemeniuk I: How many COVID-19 vaccine doses could make the difference between a fourth wave in Canada and no wave at all? New models offer four scenarios, The Globe and Mail, 2021
- Background: PubMed 26812078Gilkey MB, Calo WA, Moss JL, Shah PD, Marciniak MW, Brewer NT. Provider communication and HPV vaccination: The impact of recommendation quality. Vaccine. 2016 Feb 24;34(9):1187-92. doi: 10.1016/j.vaccine.2016.01.023. Epub 2016 Jan 24.
- Background: PubMed 30448270Lu PJ, Yankey D, Fredua B, O'Halloran AC, Williams C, Markowitz LE, Elam-Evans LD. Association of Provider Recommendation and Human Papillomavirus Vaccination Initiation among Male Adolescents Aged 13-17 Years-United States. J Pediatr. 2019 Mar;206:33-41.e1. doi: 10.1016/j.jpeds.2018.10.034. Epub 2018 Nov 15.
- Background: PubMed 31790027Cataldi JR, Kerns ME, O'Leary ST. Evidence-based strategies to increase vaccination uptake: a review. Curr Opin Pediatr. 2020 Feb;32(1):151-159. doi: 10.1097/MOP.0000000000000843.
- BackgroundDahrouge S, Glazier R, Hogg W: Defining measures of panel size. Primary health care system (PHCS) Program, 2010
- BackgroundOntario College of Family Physicians: With Vaccines Coming, Family Doctors Could Jab Millions More If Fully Involved, 2021
- Background: PubMed 25211867Anderson EL. Recommended solutions to the barriers to immunization in children and adults. Mo Med. 2014 Jul-Aug;111(4):344-8.
- BackgroundSAGE Working Group: Report of the SAGE working group on vaccine hesitancy. Geneva: World Health Organization, 2014
- Background: PubMed 10806982Briss PA, Rodewald LE, Hinman AR, Shefer AM, Strikas RA, Bernier RR, Carande-Kulis VG, Yusuf HR, Ndiaye SM, Williams SM. Reviews of evidence regarding interventions to improve vaccination coverage in children, adolescents, and adults. The Task Force on Community Preventive Services. Am J Prev Med. 2000 Jan;18(1 Suppl):97-140. doi: 10.1016/s0749-3797(99)00118-x.
- Background: PubMed 28063706Fu LY, Zimet GD, Latkin CA, Joseph JG. Associations of trust and healthcare provider advice with HPV vaccine acceptance among African American parents. Vaccine. 2017 Feb 1;35(5):802-807. doi: 10.1016/j.vaccine.2016.12.045. Epub 2017 Jan 4.
- Individual participant dataSharing planned: No. Data analysis will take place at the Institute for Clinical Evaluative Sciences (ICES). Ontario Health will provide ICES with a list of physicians that were in either the control or intervention group. This list will be transferred to ICES using a secure portal process (axway). Data will be captured from administrative databases (including COVaxON registry data) held at ICES. Data will be linked at the physician level using their encrypted CPSO (College of Physicians and Surgeons of Ontario) number.
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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.
Noah Ivers, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using Practice Facilitators to Support Physicians in people with Covid19 Vaccination and Vaccine Uptake, run by Women's College Hospital 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 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 24 Apr 2024. 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?
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?
Any vaccine dose during follow-up interval (time frame: approximately 4 months (from time of randomization until follow-up completed end of fiscal year, March 31, 2022)). 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 NCT05099497, which also lists 56 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 24 Apr 2024.