HypertensionNCT05479097
Feasibility Study of a Novel mHealth Application to Enable Community Health Workers to Manage
A study testing Anti-Hypertensive in people with Hypertension, run by University of Wisconsin, Madison at 1 site in Guatemala.
Trial summary
This is a single group study assessing the feasibility of hypertension management by community health workers (CHWs) equipped with a mobile clinical decision support (CDS) application and working with remote physician supervision. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Anti-Hypertensive
- How many people
- 32 participants
- Where
- 1 siteGuatemala
- Study dates
- 6 Feb 2023to 31 Dec 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years old
- Diagnosed with hypertension
- Blood pressure greater than or equal to 140/90 mm Hg OR
- currently taking antihypertensive medication
Who cannot join
- Pregnancy
- Severe comorbid condition(s) with life expectancy less than 1 year
Trial locations and contacts
1 site in 1 country.
Guatemala1 site
San Lucas Mission
San Lucas Tolimán, Departamento de Sololá, 07013
About this study
Official title: A Feasibility Study of a Novel mHealth Clinical Decision Support Application to Enable Community Health Workers to Manage Hypertension With Remote Physician Supervision
This is a single group study assessing the feasibility of hypertension management by community health workers (CHWs) equipped with a mobile clinical decision support (CDS) application and working with remote physician supervision.
Read the detailed description
An estimated 1.13 billion people worldwide are currently living with hypertension, the leading preventable cause of death and disability. Two thirds of these patients live in low- and middle-income countries (LMIC). Treatment of hypertension has been found to be cost-effective in reducing morbidity and mortality across a broad range of settings. Despite this, less than 10% of patients with hypertension in LMIC have good control of their blood pressure. Health systems in LMIC, which are often focused on providing episodic care for acute illnesses and suffer from inadequate and poorly distributed health care infrastructure and workforce, are ill-equipped to address the rise in chronic non-communicable diseases (NCDs) such as hypertension. Governments and NGOs are increasingly turning to community health workers (CHWs) - lay people trained to carry out a variety of tasks and who often are from or have a close connection to the communities they serve - to help fill care gaps for hypertension and other NCDs in LMIC. In most cases, CHWs have played supportive (e.g. providing patient education) rather than direct care roles. While such programs have led to improved chronic disease outcomes, they still rely on clinic-based physicians, mid-level providers or nurses to directly provide medical management, and therefore do not address the essential problem of inadequate primary care infrastructure and workforce, particularly in rural areas. Overcoming this problem is key to reducing the growing burden of untreated hypertension in LMIC.
To solve this problem, the investigators are developing an innovative mobile application to assist CHWs in the treatment of hypertension in adults with remote physician supervision. This application is built on the widely-used CommCare platform and will provide clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care. The investigators will develop and test this approach in a rural area of Guatemala with poor primary care infrastructure and where the team has worked extensively in the past and has an ongoing collaboration with a local NGO, the San Lucas Mission, and affiliated CHWs. Through this collaboration, the investigators have developed and implemented a CHW-led rural diabetes program enabled by a CDS mobile application and have demonstrated that CHWs can safely and effectively manage diabetes using the application. The hypothesis is that the investigators will be able to adapt the model to hypertension management and are evaluating the feasibility of this approach with this pilot study.
- Conditions
- Hypertension
- Being tested
- Anti-Hypertensive
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-HypertensiveDrug
Based on information entered by the CHWs into the CommCare application designed for this study, the application will provide recommendations (and underlying rationale for these recommendations) for prescription of antihypertensives (amlodipine and/or losartan OR enalapril) and medications to reduce cardiovascular risk (aspirin and atorvastatin) if indicated, lifestyle modification, and referral to the supervising physician if indicated for potential complications of hypertension.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure
Difference in systolic blood pressure from baseline to 6 months
Measured: baseline, 6 months
Difference in Diastolic Blood Pressure From Baseline to 6 Months
Difference in diastolic blood pressure from baseline to 6 months
Measured: baseline, 6 months
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140
Difference in the proportion of patients with systolic blood pressure less than or equal to 140 from baseline to 6 months
Measured: baseline, 6 months
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal
Difference in the proportion of patients with systolic blood pressure less than or equal to personalized goal from baseline to 6 months
Measured: baseline, 6 months
Proportion of Visits for Which Both the CHW Conducting the Visit and the Physician Reviewing Post-visit Data Agreed With the Antihypertensive Recommendations Provided by the CDS Application
This measure will be calculated as the proportion of visits for which both the CHW conducting the visit and the physician reviewing post-visit data agreed with the antihypertensive recommendations provided by the application.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start6 Feb 2023
- Primary completion15 Aug 2023
- Study completion31 Dec 2023
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 (13)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Sean Duffy, MD, Principal investigator, University of Wisconsin-Madison Department of Family Medicine and Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479097
- Sponsor's protocol ID
- 2022-0794
- Other IDs
- Approval Date 7/2/2022, A532050, 1R21TW011891-01
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2022
- Last updated
- 16 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, Chen J, He J. Global Disparities of Hypertension Prevalence and Control: A Systematic Analysis of Population-Based Studies From 90 Countries. Circulation. 2016 Aug 9;134(6):441-50. doi: 10.1161/CIRCULATIONAHA.115.018912.
PubMed 27502908Zhang D, Wang G, Joo H. A Systematic Review of Economic Evidence on Community Hypertension Interventions. Am J Prev Med. 2017 Dec;53(6S2):S121-S130. doi: 10.1016/j.amepre.2017.05.008.
PubMed 29153113Hunter DJ, Reddy KS. Noncommunicable diseases. N Engl J Med. 2013 Oct 3;369(14):1336-43. doi: 10.1056/NEJMra1109345. No abstract available.
PubMed 24088093Checkley W, Ghannem H, Irazola V, Kimaiyo S, Levitt NS, Miranda JJ, Niessen L, Prabhakaran D, Rabadan-Diehl C, Ramirez-Zea M, Rubinstein A, Sigamani A, Smith R, Tandon N, Wu Y, Xavier D, Yan LL; GRAND South Network, UnitedHealth Group/National Heart, Lung, and Blood Institute Centers of Excellence. Management of NCD in low- and middle-income countries. Glob Heart. 2014 Dec;9(4):431-43. doi: 10.1016/j.gheart.2014.11.003.
PubMed 25592798Vedanthan R, Bernabe-Ortiz A, Herasme OI, Joshi R, Lopez-Jaramillo P, Thrift AG, Webster J, Webster R, Yeates K, Gyamfi J, Ieremia M, Johnson C, Kamano JH, Lazo-Porras M, Limbani F, Liu P, McCready T, Miranda JJ, Mohan S, Ogedegbe O, Oldenburg B, Ovbiagele B, Owolabi M, Peiris D, Ponce-Lucero V, Praveen D, Pillay A, Schwalm JD, Tobe SW, Trieu K, Yusoff K, Fuster V. Innovative Approaches to Hypertension Control in Low- and Middle-Income Countries. Cardiol Clin. 2017 Feb;35(1):99-115. doi: 10.1016/j.ccl.2016.08.010.
PubMed 27886793Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.
PubMed 26890177Mishra SR, Neupane D, Preen D, Kallestrup P, Perry HB. Mitigation of non-communicable diseases in developing countries with community health workers. Global Health. 2015 Nov 10;11:43. doi: 10.1186/s12992-015-0129-5.
PubMed 26555199Khetan AK, Purushothaman R, Chami T, Hejjaji V, Madan Mohan SK, Josephson RA, Webel AR. The Effectiveness of Community Health Workers for CVD Prevention in LMIC. Glob Heart. 2017 Sep;12(3):233-243.e6. doi: 10.1016/j.gheart.2016.07.001. Epub 2016 Dec 16.
PubMed 27993594Svoronos T, Mjungu P, Dhadialla R, Luk R, Zue C, Jackson J, et al. CommCare: Automated quality improvement to strengthen community-based health. Weston: D-Tree International 2010
Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available.
PubMed 32370572Duffy S, Svenson J, Chavez A, Kelly M, Wise P. Empowering Community Health Workers With Mobile Technology to Treat Diabetes. Ann Fam Med. 2019 Mar;17(2):176. doi: 10.1370/afm.2361. No abstract available.
PubMed 30858263Duffy S, Norton D, Kelly M, Chavez A, Tun R, Ramirez MNG, Chen G, Wise P, Svenson J. Using Community Health Workers and a Smartphone Application to Improve Diabetes Control in Rural Guatemala. Glob Health Sci Pract. 2020 Dec 23;8(4):699-720. doi: 10.9745/GHSP-D-20-00076. Print 2020 Dec 23.
PubMed 33361237Duffy S, Chavez A, Arthur IS, Ortiz GL, Bermudez-Canete A, Nunez-Perez P, White E, Aguilar V, Aguirre J, Dang D, Perez Abaj CS, Letona Lopez YE, Tun R, Valley TM. Feasibility study of a novel mHealth clinical decision support application to enable community health workers to manage hypertension in rural Guatemala. J Glob Health. 2026 Jul 31;16:04232. doi: 10.7189/jogh.16.04232.
PubMed 42533611
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Novel mHealth Clinical Decision Support Application to Enable Community Health Workers to Manage Hypertension With Remote Physician Supervision
- ClinicalTrials.gov ID
- NCT05479097
- Acronym / sponsor ID
- 2022-0794
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single group study assessing the feasibility of hypertension management by community health workers (CHWs) equipped with a mobile clinical decision support (CDS) application and working with remote physician supervision.
Detailed description
An estimated 1.13 billion people worldwide are currently living with hypertension, the leading preventable cause of death and disability. Two thirds of these patients live in low- and middle-income countries (LMIC). Treatment of hypertension has been found to be cost-effective in reducing morbidity and mortality across a broad range of settings. Despite this, less than 10% of patients with hypertension in LMIC have good control of their blood pressure. Health systems in LMIC, which are often focused on providing episodic care for acute illnesses and suffer from inadequate and poorly distributed health care infrastructure and workforce, are ill-equipped to address the rise in chronic non-communicable diseases (NCDs) such as hypertension. Governments and NGOs are increasingly turning to community health workers (CHWs) - lay people trained to carry out a variety of tasks and who often are from or have a close connection to the communities they serve - to help fill care gaps for hypertension and other NCDs in LMIC. In most cases, CHWs have played supportive (e.g. providing patient education) rather than direct care roles. While such programs have led to improved chronic disease outcomes, they still rely on clinic-based physicians, mid-level providers or nurses to directly provide medical management, and therefore do not address the essential problem of inadequate primary care infrastructure and workforce, particularly in rural areas. Overcoming this problem is key to reducing the growing burden of untreated hypertension in LMIC.
To solve this problem, the investigators are developing an innovative mobile application to assist CHWs in the treatment of hypertension in adults with remote physician supervision. This application is built on the widely-used CommCare platform and will provide clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care. The investigators will develop and test this approach in a rural area of Guatemala with poor primary care infrastructure and where the team has worked extensively in the past and has an ongoing collaboration with a local NGO, the San Lucas Mission, and affiliated CHWs. Through this collaboration, the investigators have developed and implemented a CHW-led rural diabetes program enabled by a CDS mobile application and have demonstrated that CHWs can safely and effectively manage diabetes using the application. The hypothesis is that the investigators will be able to adapt the model to hypertension management and are evaluating the feasibility of this approach with this pilot study.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than 18 years old
- Diagnosed with hypertension
- Blood pressure greater than or equal to 140/90 mm Hg OR
- currently taking antihypertensive medication
Key exclusion criteria (2 listed)
- Pregnancy
- Severe comorbid condition(s) with life expectancy less than 1 year
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 |
|---|---|---|
| Anti-HypertensiveBased on information entered by the CHWs into the CommCare application designed for this study, the application will provide recommendations (and underlying rationale for these recommendations) for prescription of antihypertensives (amlodipine and/or losartan OR enalapril) and medications to reduce cardiovascular risk (aspirin and atorvastatin) if indicated, lifestyle modification, and referral to the supervising physician if indicated for potential complications of hypertension. | Drug | – |
Primary outcome
Change in Systolic Blood Pressure
Time frame: baseline, 6 months
Difference in systolic blood pressure from baseline to 6 months
Difference in Diastolic Blood Pressure From Baseline to 6 Months
Time frame: baseline, 6 months
Difference in diastolic blood pressure from baseline to 6 months
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to 140
Time frame: baseline, 6 months
Difference in the proportion of patients with systolic blood pressure less than or equal to 140 from baseline to 6 months
Change in the Proportion of Patients With Systolic Blood Pressure Less Than or Equal to Personalized Goal
Time frame: baseline, 6 months
Difference in the proportion of patients with systolic blood pressure less than or equal to personalized goal from baseline to 6 months
Proportion of Visits for Which Both the CHW Conducting the Visit and the Physician Reviewing Post-visit Data Agreed With the Antihypertensive Recommendations Provided by the CDS Application
Time frame: 6 months
This measure will be calculated as the proportion of visits for which both the CHW conducting the visit and the physician reviewing post-visit data agreed with the antihypertensive recommendations provided by the application.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27502908Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, Chen J, He J. Global Disparities of Hypertension Prevalence and Control: A Systematic Analysis of Population-Based Studies From 90 Countries. Circulation. 2016 Aug 9;134(6):441-50. doi: 10.1161/CIRCULATIONAHA.115.018912.
- Background: PubMed 29153113Zhang D, Wang G, Joo H. A Systematic Review of Economic Evidence on Community Hypertension Interventions. Am J Prev Med. 2017 Dec;53(6S2):S121-S130. doi: 10.1016/j.amepre.2017.05.008.
- Background: PubMed 24088093Hunter DJ, Reddy KS. Noncommunicable diseases. N Engl J Med. 2013 Oct 3;369(14):1336-43. doi: 10.1056/NEJMra1109345. No abstract available.
- Background: PubMed 25592798Checkley W, Ghannem H, Irazola V, Kimaiyo S, Levitt NS, Miranda JJ, Niessen L, Prabhakaran D, Rabadan-Diehl C, Ramirez-Zea M, Rubinstein A, Sigamani A, Smith R, Tandon N, Wu Y, Xavier D, Yan LL; GRAND South Network, UnitedHealth Group/National Heart, Lung, and Blood Institute Centers of Excellence. Management of NCD in low- and middle-income countries. Glob Heart. 2014 Dec;9(4):431-43. doi: 10.1016/j.gheart.2014.11.003.
- Background: PubMed 27886793Vedanthan R, Bernabe-Ortiz A, Herasme OI, Joshi R, Lopez-Jaramillo P, Thrift AG, Webster J, Webster R, Yeates K, Gyamfi J, Ieremia M, Johnson C, Kamano JH, Lazo-Porras M, Limbani F, Liu P, McCready T, Miranda JJ, Mohan S, Ogedegbe O, Oldenburg B, Ovbiagele B, Owolabi M, Peiris D, Ponce-Lucero V, Praveen D, Pillay A, Schwalm JD, Tobe SW, Trieu K, Yusoff K, Fuster V. Innovative Approaches to Hypertension Control in Low- and Middle-Income Countries. Cardiol Clin. 2017 Feb;35(1):99-115. doi: 10.1016/j.ccl.2016.08.010.
- Background: PubMed 26890177Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.
- Background: PubMed 26555199Mishra SR, Neupane D, Preen D, Kallestrup P, Perry HB. Mitigation of non-communicable diseases in developing countries with community health workers. Global Health. 2015 Nov 10;11:43. doi: 10.1186/s12992-015-0129-5.
- Background: PubMed 27993594Khetan AK, Purushothaman R, Chami T, Hejjaji V, Madan Mohan SK, Josephson RA, Webel AR. The Effectiveness of Community Health Workers for CVD Prevention in LMIC. Glob Heart. 2017 Sep;12(3):233-243.e6. doi: 10.1016/j.gheart.2016.07.001. Epub 2016 Dec 16.
- BackgroundSvoronos T, Mjungu P, Dhadialla R, Luk R, Zue C, Jackson J, et al. CommCare: Automated quality improvement to strengthen community-based health. Weston: D-Tree International 2010
- Background: PubMed 32370572Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available.
- Background: PubMed 30858263Duffy S, Svenson J, Chavez A, Kelly M, Wise P. Empowering Community Health Workers With Mobile Technology to Treat Diabetes. Ann Fam Med. 2019 Mar;17(2):176. doi: 10.1370/afm.2361. No abstract available.
- Background: PubMed 33361237Duffy S, Norton D, Kelly M, Chavez A, Tun R, Ramirez MNG, Chen G, Wise P, Svenson J. Using Community Health Workers and a Smartphone Application to Improve Diabetes Control in Rural Guatemala. Glob Health Sci Pract. 2020 Dec 23;8(4):699-720. doi: 10.9745/GHSP-D-20-00076. Print 2020 Dec 23.
- World Health Organization. Hypertension Fact Sheet 2019Link provided by the sponsor.
- Global Action Plan for the Prevention and Control of NCDs 2013-2020Link provided by the sponsor.
- World Health Organization (WHO) HEARTS Technical PackageLink provided by the sponsor.
- World Health Organization. Guideline for the pharmacological treatment of hypertension in adults.Link 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. This study is not recruiting at the moment.
Sean Duffy, MD principal investigator
University of Wisconsin-Madison Department of Family Medicine and Community Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Hypertensive in people with Hypertension, run by University of Wisconsin, Madison at 1 site in Guatemala.
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 4 inclusion and 2 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 16 Jul 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 Guatemala. 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 16 Jul 2024). 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?
Change in Systolic Blood Pressure (time frame: baseline, 6 months). The study lists 5 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 NCT05479097, which also lists 13 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 16 Jul 2024.