Coronary Artery DiseaseNCT05628337
The TEACH (Texting After ACS Discharge) Pilot Randomized Trial
A study testing Motivational texting in people with Coronary Artery Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Although there have been substantial advances in the treatment of heart disease, heart attacks remain one of the leading causes of death and suffering around the world. Each year, more than 80,000 patients are hospitalized with heart attacks or related conditions in Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Motivational texting
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jun 2022to 31 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years old
- Presentation or admission to Sunnybrook Hospital with diagnosis of Acute Coronary Syndrome (ACS)
- Access to a cellphone that can receive text messages
Who cannot join
- Inability to consent for study in English
- Inability to read or answer English texts
- Lack of cellphone with SMS capability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mobile Text Intervention on Transitions of Care and Outcomes After Hospitalization With Acute Coronary Syndrome - The TEACH (Texting After ACS Discharge) Pilot Randomized Trial
Although there have been substantial advances in the treatment of heart disease, heart attacks remain one of the leading causes of death and suffering around the world. Each year, more than 80,000 patients are hospitalized with heart attacks or related conditions in Canada. Even after discharge, patients are at high risk of having complications such that almost one in two patients after a heart attack will be readmitted to hospitals within the first year. Given the shortage of doctors and allied health care professionals, there is an emerging focus of digital health as a way to improve the care and outcomes after heart attacks. With more than 30 million cell phone users across Canada and almost all are already using text message services, the goal of this study is to conduct a pilot test using an innovative clinical trial design to see if the care and outlook of heart attack patients using mobile text messages can be improved.
Read the detailed description
The healthcare system is in desperate need of novel strategies to better engage with cardiac patients to improve care and how patients interact with the healthcare system. Although almost everyone has a mobile phone in Canada, healthcare systems have not sufficiently explored mobile health strategies that can improve health. Yet, a recent survey suggests that alternative access to healthcare is highly desirable by Canadians. Adoption of mobile health technologies has the potential to add an additional avenue for how the healthcare system can interact with patients. Most importantly, these strategies are already used by many other industries and thus can be easily implementable and expandable in healthcare institutions across the country.
Due to the COVID-19 pandemic, it has become evident that the way healthcare is delivered in the future will be different than it has been for many decades. With the conversion of many forms of care to virtual and online platforms, mobile-based care could become an important component of cardiac care. Thus, this project will help to explore the use of mobile-based virtual care platforms in cardiac follow-up in the ACS populations.
The main goal of the study is to test the feasibility and potential effects of mobile text message-based intervention on transitions of care after hospitalization with heart attack.
The hypotheses are that i) the majority of patients will be willing to participate in the pilot study and continue to receive text messages during the study, ii) the group that receives texting will have more frequent physician visits and take medication more consistently at 1 year after discharge, iii) the group that receives texting will have lower rates of readmission at 1 year after discharge.
One of the most innovative aspects of this study is the ability to conduct an intervention of mobile technology and follow-up outcomes of patients using existing registries and data that are routinely collected in day-to-day care. Accordingly, this study will be conducted at a fraction of the cost compared to a traditional randomized design. It also means that the study concept could be easily replicated in many different areas of medicine.
The main goal of the study is to test the feasibility of mobile text message-based interventions on transitions of care after hospitalization with a heart attack.
Medication compliance, re-hospitalization, and Emergency Department presentation will be tracked. These outcomes will be measured using ICES database linking patient health care number, to determine hospital admissions, ER presentations, and prescription filling.
- Conditions
- Coronary Artery Disease
- Being tested
- Motivational texting, Control
- Keywords
- Mobile health
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational textingOther
Health related information relevant to a subject's diagnosis and ongoing treatment
ControlOther
Non-motivational text messages containing no specific health information
| Study group | Role | What they receive |
|---|---|---|
| Texting intervention group | Experimental | Subjects will receive specific health-related texts Receives: Other: Motivational texting |
| Control group | Placebo comparator | Subjects will receive general text messages without health information Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician visit
Visit to a primary care physician or cardiologist specialist
Measured: Within one month, 3 months, and 12 months of randomization
Secondary outcomes (3)
Emergency Department presentation
Presentation to an ED for any cause
Measured: Within one month, 3 months, and 12 months of randomization
Re-hospitalization
To assess the need to re-hospitalize patient due to CAD
Measured: Within one month, 3 months, and 12 months of hospital discharge
Medication compliance
Assessment of medication compliance related to CAD
Measured: Within one month, 3 months, and 12 months of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start16 Jun 2022
- Primary completion31 May 2024
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized trial, prospective, single centre, study intervention (texting motivation messages vs. placebo control), follow-up with administrative database linkage
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Ko, MD, Principal investigator, Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628337
- Sponsor's protocol ID
- 3563
- Status last verified
- Apr 2025
- First submitted
- 16 Nov 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchis-Gomar F, Perez-Quilis C, Leischik R, Lucia A. Epidemiology of coronary heart disease and acute coronary syndrome. Ann Transl Med. 2016 Jul;4(13):256. doi: 10.21037/atm.2016.06.33.
PubMed 275001572. Canadian Institute for Health Information. CIHI Data Quality Study of Ontario Emergency Department Visits 2004-2005: Volume II of IV - Main Study Findings Ottawa, Ontario 2008.3.
Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.
PubMed 19339721Krumholz HM. Post-hospital syndrome--an acquired, transient condition of generalized risk. N Engl J Med. 2013 Jan 10;368(2):100-2. doi: 10.1056/NEJMp1212324. No abstract available.
PubMed 23301730Leppin AL, Gionfriddo MR, Kessler M, Brito JP, Mair FS, Gallacher K, Wang Z, Erwin PJ, Sylvester T, Boehmer K, Ting HH, Murad MH, Shippee ND, Montori VM. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Intern Med. 2014 Jul;174(7):1095-107. doi: 10.1001/jamainternmed.2014.1608.
PubMed 24820131Czarnecki A, Chong A, Lee DS, Schull MJ, Tu JV, Lau C, Farkouh ME, Ko DT. Association between physician follow-up and outcomes of care after chest pain assessment in high-risk patients. Circulation. 2013 Apr 2;127(13):1386-94. doi: 10.1161/CIRCULATIONAHA.112.000737.
PubMed 23547178Czarnecki A, Wang JT, Tu JV, Lee DS, Schull MJ, Lau C, Farkouh ME, Wijeysundera HC, Ko DT. The role of primary care physician and cardiologist follow-up for low-risk patients with chest pain after emergency department assessment. Am Heart J. 2014 Sep;168(3):289-95. doi: 10.1016/j.ahj.2014.05.016. Epub 2014 Jun 9.
PubMed 25173539Wong MK, Wang JT, Czarnecki A, Koh M, Tu JV, Schull MJ, Wijeysundera HC, Lau C, Ko DT. Factors associated with physician follow-up among patients with chest pain discharged from the emergency department. CMAJ. 2015 Mar 17;187(5):E160-8. doi: 10.1503/cmaj.141294. Epub 2015 Feb 23.
PubMed 25712950Huo X, Krumholz HM, Bai X, Spatz ES, Ding Q, Horak P, Zhao W, Gong Q, Zhang H, Yan X, Sun Y, Liu J, Wu X, Guan W, Wang X, Li J, Li X, Spertus JA, Masoudi FA, Zheng X. Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus: A Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Sep;12(9):e005805. doi: 10.1161/CIRCOUTCOMES.119.005805. Epub 2019 Aug 31.
PubMed 31474119Thakkar J, Kurup R, Laba TL, Santo K, Thiagalingam A, Rodgers A, Woodward M, Redfern J, Chow CK. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. JAMA Intern Med. 2016 Mar;176(3):340-9. doi: 10.1001/jamainternmed.2015.7667.
PubMed 26831740Adler AJ, Martin N, Mariani J, Tajer CD, Owolabi OO, Free C, Serrano NC, Casas JP, Perel P. Mobile phone text messaging to improve medication adherence in secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017 Apr 29;4(4):CD011851. doi: 10.1002/14651858.CD011851.pub2.
PubMed 28455948Shariful Islam SM, Farmer AJ, Bobrow K, Maddison R, Whittaker R, Pfaeffli Dale LA, Lechner A, Lear S, Eapen Z, Niessen LW, Santo K, Stepien S, Redfern J, Rodgers A, Chow CK. Mobile phone text-messaging interventions aimed to prevent cardiovascular diseases (Text2PreventCVD): systematic review and individual patient data meta-analysis. Open Heart. 2019 Oct 9;6(2):e001017. doi: 10.1136/openhrt-2019-001017. eCollection 2019.
PubMed 31673381Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, Jan S, Graves N, de Keizer L, Barry T, Bompoint S, Stepien S, Whittaker R, Rodgers A, Thiagalingam A. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1255-63. doi: 10.1001/jama.2015.10945.
PubMed 2639384814. Communications Monitoring Report 2018. 2019; https://crtc.gc.ca/pubs/cmr2018-en.pdf. Accessed November 1, 2019.15.
15. Lauer MS, D'Agostino RB, Sr. The randomized registry trial--the next disruptive technology in clinical research? N Engl J Med. 2013;369(17):1579-1581.16. Ko DT, Alter DA, Guo H, et al. High-Density Lipoprotein Cholesterol and Cause-Specific Mortality in Individuals Without Previous Cardiovascular Conditions: The CANHEART Study. J Am Coll Cardiol. 2016;68(19):2073-2083.17.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobile Text Intervention on Transitions of Care and Outcomes After Hospitalization With Acute Coronary Syndrome - The TEACH (Texting After ACS Discharge) Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT05628337
- Acronym / sponsor ID
- 3563
- Conditions
- Coronary Artery Disease
- Keywords
- Mobile health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 28 Nov 2022 (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.
Although there have been substantial advances in the treatment of heart disease, heart attacks remain one of the leading causes of death and suffering around the world. Each year, more than 80,000 patients are hospitalized with heart attacks or related conditions in Canada. Even after discharge, patients are at high risk of having complications such that almost one in two patients after a heart attack will be readmitted to hospitals within the first year. Given the shortage of doctors and allied health care professionals, there is an emerging focus of digital health as a way to improve the care and outcomes after heart attacks. With more than 30 million cell phone users across Canada and almost all are already using text message services, the goal of this study is to conduct a pilot test using an innovative clinical trial design to see if the care and outlook of heart attack patients using mobile text messages can be improved.
Detailed description
The healthcare system is in desperate need of novel strategies to better engage with cardiac patients to improve care and how patients interact with the healthcare system. Although almost everyone has a mobile phone in Canada, healthcare systems have not sufficiently explored mobile health strategies that can improve health. Yet, a recent survey suggests that alternative access to healthcare is highly desirable by Canadians. Adoption of mobile health technologies has the potential to add an additional avenue for how the healthcare system can interact with patients. Most importantly, these strategies are already used by many other industries and thus can be easily implementable and expandable in healthcare institutions across the country.
Due to the COVID-19 pandemic, it has become evident that the way healthcare is delivered in the future will be different than it has been for many decades. With the conversion of many forms of care to virtual and online platforms, mobile-based care could become an important component of cardiac care. Thus, this project will help to explore the use of mobile-based virtual care platforms in cardiac follow-up in the ACS populations.
The main goal of the study is to test the feasibility and potential effects of mobile text message-based intervention on transitions of care after hospitalization with heart attack.
The hypotheses are that i) the majority of patients will be willing to participate in the pilot study and continue to receive text messages during the study, ii) the group that receives texting will have more frequent physician visits and take medication more consistently at 1 year after discharge, iii) the group that receives texting will have lower rates of readmission at 1 year after discharge.
One of the most innovative aspects of this study is the ability to conduct an intervention of mobile technology and follow-up outcomes of patients using existing registries and data that are routinely collected in day-to-day care. Accordingly, this study will be conducted at a fraction of the cost compared to a traditional randomized design. It also means that the study concept could be easily replicated in many different areas of medicine.
The main goal of the study is to test the feasibility of mobile text message-based interventions on transitions of care after hospitalization with a heart attack.
Medication compliance, re-hospitalization, and Emergency Department presentation will be tracked. These outcomes will be measured using ICES database linking patient health care number, to determine hospital admissions, ER presentations, and prescription filling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized trial, prospective, single centre, study intervention (texting motivation messages vs. placebo control), follow-up with administrative database linkage
| Arm | Type | Receives |
|---|---|---|
| Texting intervention group | Experimental | Other: Motivational textingSubjects will receive specific health-related texts |
| Control group | Placebo comparator | Other: ControlSubjects will receive general text messages without health information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years old
- Presentation or admission to Sunnybrook Hospital with diagnosis of Acute Coronary Syndrome (ACS)
- Access to a cellphone that can receive text messages
Key exclusion criteria (3 listed)
- Inability to consent for study in English
- Inability to read or answer English texts
- Lack of cellphone with SMS capability
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 |
|---|---|---|
| Motivational textingHealth related information relevant to a subject's diagnosis and ongoing treatment | Other | Texting intervention group |
| ControlNon-motivational text messages containing no specific health information | Other | Control group |
Primary outcome
Physician visit
Time frame: Within one month, 3 months, and 12 months of randomization
Visit to a primary care physician or cardiologist specialist
3 secondary outcomes
Emergency Department presentation
Time frame: Within one month, 3 months, and 12 months of randomization
Re-hospitalization
Time frame: Within one month, 3 months, and 12 months of hospital discharge
Medication compliance
Time frame: Within one month, 3 months, and 12 months of hospital discharge
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 27 Apr 2025.
- Background: PubMed 27500157Sanchis-Gomar F, Perez-Quilis C, Leischik R, Lucia A. Epidemiology of coronary heart disease and acute coronary syndrome. Ann Transl Med. 2016 Jul;4(13):256. doi: 10.21037/atm.2016.06.33.
- Background2. Canadian Institute for Health Information. CIHI Data Quality Study of Ontario Emergency Department Visits 2004-2005: Volume II of IV - Main Study Findings Ottawa, Ontario 2008.3.
- Background: PubMed 19339721Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.
- Background: PubMed 23301730Krumholz HM. Post-hospital syndrome--an acquired, transient condition of generalized risk. N Engl J Med. 2013 Jan 10;368(2):100-2. doi: 10.1056/NEJMp1212324. No abstract available.
- Background: PubMed 24820131Leppin AL, Gionfriddo MR, Kessler M, Brito JP, Mair FS, Gallacher K, Wang Z, Erwin PJ, Sylvester T, Boehmer K, Ting HH, Murad MH, Shippee ND, Montori VM. Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. JAMA Intern Med. 2014 Jul;174(7):1095-107. doi: 10.1001/jamainternmed.2014.1608.
- Background: PubMed 23547178Czarnecki A, Chong A, Lee DS, Schull MJ, Tu JV, Lau C, Farkouh ME, Ko DT. Association between physician follow-up and outcomes of care after chest pain assessment in high-risk patients. Circulation. 2013 Apr 2;127(13):1386-94. doi: 10.1161/CIRCULATIONAHA.112.000737.
- Background: PubMed 25173539Czarnecki A, Wang JT, Tu JV, Lee DS, Schull MJ, Lau C, Farkouh ME, Wijeysundera HC, Ko DT. The role of primary care physician and cardiologist follow-up for low-risk patients with chest pain after emergency department assessment. Am Heart J. 2014 Sep;168(3):289-95. doi: 10.1016/j.ahj.2014.05.016. Epub 2014 Jun 9.
- Background: PubMed 25712950Wong MK, Wang JT, Czarnecki A, Koh M, Tu JV, Schull MJ, Wijeysundera HC, Lau C, Ko DT. Factors associated with physician follow-up among patients with chest pain discharged from the emergency department. CMAJ. 2015 Mar 17;187(5):E160-8. doi: 10.1503/cmaj.141294. Epub 2015 Feb 23.
- Background: PubMed 31474119Huo X, Krumholz HM, Bai X, Spatz ES, Ding Q, Horak P, Zhao W, Gong Q, Zhang H, Yan X, Sun Y, Liu J, Wu X, Guan W, Wang X, Li J, Li X, Spertus JA, Masoudi FA, Zheng X. Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus: A Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Sep;12(9):e005805. doi: 10.1161/CIRCOUTCOMES.119.005805. Epub 2019 Aug 31.
- Background: PubMed 26831740Thakkar J, Kurup R, Laba TL, Santo K, Thiagalingam A, Rodgers A, Woodward M, Redfern J, Chow CK. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. JAMA Intern Med. 2016 Mar;176(3):340-9. doi: 10.1001/jamainternmed.2015.7667.
- Background: PubMed 28455948Adler AJ, Martin N, Mariani J, Tajer CD, Owolabi OO, Free C, Serrano NC, Casas JP, Perel P. Mobile phone text messaging to improve medication adherence in secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2017 Apr 29;4(4):CD011851. doi: 10.1002/14651858.CD011851.pub2.
- Background: PubMed 31673381Shariful Islam SM, Farmer AJ, Bobrow K, Maddison R, Whittaker R, Pfaeffli Dale LA, Lechner A, Lear S, Eapen Z, Niessen LW, Santo K, Stepien S, Redfern J, Rodgers A, Chow CK. Mobile phone text-messaging interventions aimed to prevent cardiovascular diseases (Text2PreventCVD): systematic review and individual patient data meta-analysis. Open Heart. 2019 Oct 9;6(2):e001017. doi: 10.1136/openhrt-2019-001017. eCollection 2019.
- Communications Monitoring Report 2018. 2019Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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.
Dennis Ko, MD principal investigator
Research Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational texting in people with Coronary Artery Disease, run by Sunnybrook Health Sciences Centre 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 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 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. Some participants in this study may receive a placebo. 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?
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?
Physician visit (time frame: Within one month, 3 months, and 12 months of randomization). 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 NCT05628337, which also lists 16 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 27 Apr 2025.