Uncontrolled HypertensionENGAGE-HTNNCT06543394
Engaging Patients in Adherence Interventions Using Behavioral Science
A study testing Primer postcard, Behavioral theory-informed recruitment letter and 2 phone calls in people with Uncontrolled Hypertension, run by Columbia University at 1 site in United States.
Trial summary
The overarching goal of the proposed research is to prepare an evidence-based clinical pharmacist-delivered medication adherence intervention for sustainable implementation and dissemination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Primer postcard, Behavioral theory-informed recruitment letter and 2 phone calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2024to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Receive care at a Columbia-affiliated primary care clinic in the Ambulatory Care Network
- Diagnosis of hypertension
- Office BP >=140/90 mmHg at most recent office visit
- Prescribed at least one blood pressure medication
- Nonadherent to at least one blood pressure medication as per pharmacy dispense records (proportion of days covered <80% to at least one eligible medication in last 6 months)
Who cannot join
- Do not speak English or Spanish
- Pregnancy, dementia or terminal conditions as per ICD-10 codes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Optimizing Recruitment Methodology for Medication Adherence Interventions: The ENGaging Patients in Adherence Interventions UsinG Behavioral SciencE (ENGAGE) Randomized Factorial Trial
The overarching goal of the proposed research is to prepare an evidence-based clinical pharmacist-delivered medication adherence intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model Stage 4 trial called STIC2IT, this study will include an NIH Stage Model Stage 5 Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The overarching hypothesis is that investigators can identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings.
Accordingly, this study will perform testing of behaviorally-informed recruitment approaches in a primary care setting that serves patients from under-resourced communities. Patients will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having a primary care clinician at the participating practice as well as uncontrolled hypertension and suboptimal adherence to blood pressure medications based on pharmacy fill data linked to the electronic health record (EHR). The primary care clinicians of eligible patients identified through the EHR will have the opportunity to opt-out any patients they wish not to be included. Patients will then be randomized to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes/no), (2) the most successful recruitment letter from a preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (up to 4 calls vs. up to 2 calls).
Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists trained in the brief negotiated interviewing approach used in the STIC2IT trial. The primary outcome will be completion of a clinical pharmacist appointment within 12 weeks of randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, pharmacy fill adherence to statins and blood pressure medications over the 3-month follow-up, and clinical outcomes, including blood pressure as per EHR data in the 3 months after randomization.
Read the detailed description
Participants will be recruited from Columbia University Irving Medical Center (CUIMC)-affiliated primary care clinics that are part of the New York Presbyterian (NYP) Ambulatory Care Network (ACN). These clinics provide care to patients in the catchment area of CUIMC which is notable for substantial racial, ethnic, and economic diversity. The study team will identify participants with uncontrolled hypertension (last office BP <140/90 mmHg) who also are nonadherent (PDC<80%) to at least one antihypertensive medication class and meet other study eligibility criteria.
Participants will then be randomized using a 2^3 factorial approach to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes vs no), (2) a behavioral theory-informed letter script (vs usual scripted letter), and (3) intensity of the recruitment outreach (up to 4 calls vs up to 2 calls). Recruitment outreach will be conducted by members of the study team, who will be trained to deliver different interventions based on a patient's assigned arm. Enrollment will be staggered over an approximately 4-month period so as not to overwhelm the scheduling staff and mimic how quality improvement programs are conducted in typical practice.
Participants who agree to participate in the adherence counseling session after receiving any of the 8 combinations of recruitment strategies will be scheduled to receive a brief evidence-based medication adherence counseling session known as brief negotiated interviewing. Patients who schedule a counseling session with a clinical pharmacist will receive a reminder call before their appointment. This will involve a 30-minute or less telephone or video visit with a nurse or clinical pharmacist who will use a semi-structured guide to confirm the patient's treatment regimen, engage them in sharing potential barriers to adherence or other factors that may be contributing to poor disease control, discuss their readiness to modify behaviors, and work with the patient to develop a shared plan.
The study will concurrently test whether 1) inclusion of a mailed primer is better than no inclusion, 2) whether use of a behavioral theory-informed message-framing strategy in the recruitment letter is better than the usual approach that does not include theory-informed message framing in a recruitment letter, and 3) whether increasing the intensity of recruitment outreach after the letter through up to 4 phone calls is better than up to 2 phone calls. The primary outcome for the study will be whether or not patients completed the adherence counseling session within 12 weeks of randomization. The secondary outcome will be whether patients agreed to have the counseling session scheduled. Exploratory outcomes will include the effects on medication adherence, blood pressure, and LDL cholesterol 3 months after randomization.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Primer postcard, Control recruitment letter, Behavioral theory-informed recruitment letter, 2 phone calls, 4 phone calls
- Keywords
- medication adherence
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primer postcardBehavioural
Mailed primer postcard
Control recruitment letterBehavioural
Mailed recruitment letter with usual care message framing
Behavioral theory-informed recruitment letterBehavioural
Mailed recruitment letter with prospect-theory informed message framing
2 phone callsBehavioural
Up to 2 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit
4 phone callsBehavioural
Up to 4 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit
| Study group | Role | What they receive |
|---|---|---|
| Postcard/behavioral letter/4 calls | Active comparator | Mailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing Receives: Behavioral: Primer postcard; Behavioral: Behavioral theory-informed recruitment letter; Behavioral: 4 phone calls |
| No postcard/behavioral letter/4 calls | Active comparator | Mailed a prospect-theory informed recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing Receives: Behavioral: Behavioral theory-informed recruitment letter; Behavioral: 4 phone calls |
| Postcard/control letter/4 calls | Active comparator | Mailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing Receives: Behavioral: Primer postcard; Behavioral: Control recruitment letter; Behavioral: 4 phone calls |
| No postcard/control letter/4 calls | Active comparator | Mailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing Receives: Behavioral: Control recruitment letter; Behavioral: 4 phone calls |
| Postcard/behavioral letter/2 calls | Active comparator | Mailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing Receives: Behavioral: Primer postcard; Behavioral: Behavioral theory-informed recruitment letter; Behavioral: 2 phone calls |
| No postcard/behavioral letter/2 calls | Active comparator | Mailed a prospect theory-informed recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing Receives: Behavioral: Behavioral theory-informed recruitment letter; Behavioral: 2 phone calls |
| Postcard/control letter/2 calls | Active comparator | Mailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing Receives: Behavioral: Primer postcard; Behavioral: Control recruitment letter; Behavioral: 2 phone calls |
| No postcare/control letter/2 calls | Active comparator | Mailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing Receives: Behavioral: Control recruitment letter; Behavioral: 2 phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who completed an adherence counseling session
Measures patient attendance at a single adherence counseling session
Measured: 12 weeks
Secondary outcomes (5)
Number of participants who scheduled an adherence counseling session
Patient scheduled an adherence counseling session
Measured: 12 weeks
Number of days that participants were adherent to blood pressure medication
Number of days covered for blood pressure medications >= 80%
Measured: 12 weeks
Number of days that participants were adherent to statin medication
Number of days covered for statin medications >= 80%
Measured: 12 weeks
Systolic blood pressure
Systolic blood pressure at office visit
Measured: 12 weeks
Diastolic blood pressure
Diastolic blood pressure at office visit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start8 Nov 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brigham and Women's Hospital
- Responsible party
- Principal investigator, Ian Kronish, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543394
- Sponsor's protocol ID
- AAAV0521
- Other IDs
- P30AG064198
- Acronym
- ENGAGE-HTN
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make available a de-identified database upon request
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Recruitment Methodology for Medication Adherence Interventions: The ENGaging Patients in Adherence Interventions UsinG Behavioral SciencE (ENGAGE) Randomized Factorial Trial
- ClinicalTrials.gov ID
- NCT06543394
- Acronym / sponsor ID
- ENGAGE-HTN / AAAV0521
- Conditions
- Uncontrolled Hypertension
- Keywords
- medication adherence
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 584 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brigham and Women's Hospital
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Aug 2024 (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 overarching goal of the proposed research is to prepare an evidence-based clinical pharmacist-delivered medication adherence intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model Stage 4 trial called STIC2IT, this study will include an NIH Stage Model Stage 5 Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The overarching hypothesis is that investigators can identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings.
Accordingly, this study will perform testing of behaviorally-informed recruitment approaches in a primary care setting that serves patients from under-resourced communities. Patients will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having a primary care clinician at the participating practice as well as uncontrolled hypertension and suboptimal adherence to blood pressure medications based on pharmacy fill data linked to the electronic health record (EHR). The primary care clinicians of eligible patients identified through the EHR will have the opportunity to opt-out any patients they wish not to be included. Patients will then be randomized to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes/no), (2) the most successful recruitment letter from a preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (up to 4 calls vs. up to 2 calls).
Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists trained in the brief negotiated interviewing approach used in the STIC2IT trial. The primary outcome will be completion of a clinical pharmacist appointment within 12 weeks of randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, pharmacy fill adherence to statins and blood pressure medications over the 3-month follow-up, and clinical outcomes, including blood pressure as per EHR data in the 3 months after randomization.
Detailed description
Participants will be recruited from Columbia University Irving Medical Center (CUIMC)-affiliated primary care clinics that are part of the New York Presbyterian (NYP) Ambulatory Care Network (ACN). These clinics provide care to patients in the catchment area of CUIMC which is notable for substantial racial, ethnic, and economic diversity. The study team will identify participants with uncontrolled hypertension (last office BP <140/90 mmHg) who also are nonadherent (PDC<80%) to at least one antihypertensive medication class and meet other study eligibility criteria.
Participants will then be randomized using a 2^3 factorial approach to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes vs no), (2) a behavioral theory-informed letter script (vs usual scripted letter), and (3) intensity of the recruitment outreach (up to 4 calls vs up to 2 calls). Recruitment outreach will be conducted by members of the study team, who will be trained to deliver different interventions based on a patient's assigned arm. Enrollment will be staggered over an approximately 4-month period so as not to overwhelm the scheduling staff and mimic how quality improvement programs are conducted in typical practice.
Participants who agree to participate in the adherence counseling session after receiving any of the 8 combinations of recruitment strategies will be scheduled to receive a brief evidence-based medication adherence counseling session known as brief negotiated interviewing. Patients who schedule a counseling session with a clinical pharmacist will receive a reminder call before their appointment. This will involve a 30-minute or less telephone or video visit with a nurse or clinical pharmacist who will use a semi-structured guide to confirm the patient's treatment regimen, engage them in sharing potential barriers to adherence or other factors that may be contributing to poor disease control, discuss their readiness to modify behaviors, and work with the patient to develop a shared plan.
The study will concurrently test whether 1) inclusion of a mailed primer is better than no inclusion, 2) whether use of a behavioral theory-informed message-framing strategy in the recruitment letter is better than the usual approach that does not include theory-informed message framing in a recruitment letter, and 3) whether increasing the intensity of recruitment outreach after the letter through up to 4 phone calls is better than up to 2 phone calls. The primary outcome for the study will be whether or not patients completed the adherence counseling session within 12 weeks of randomization. The secondary outcome will be whether patients agreed to have the counseling session scheduled. Exploratory outcomes will include the effects on medication adherence, blood pressure, and LDL cholesterol 3 months after randomization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Postcard/behavioral letter/4 calls | Active comparator | Behavioral: Primer postcard, Behavioral: Behavioral theory-informed recruitment letter, Behavioral: 4 phone callsMailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing |
| No postcard/behavioral letter/4 calls | Active comparator | Behavioral: Behavioral theory-informed recruitment letter, Behavioral: 4 phone callsMailed a prospect-theory informed recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing |
| Postcard/control letter/4 calls | Active comparator | Behavioral: Primer postcard, Behavioral: Control recruitment letter, Behavioral: 4 phone callsMailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing |
| No postcard/control letter/4 calls | Active comparator | Behavioral: Control recruitment letter, Behavioral: 4 phone callsMailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 4 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing |
| Postcard/behavioral letter/2 calls | Active comparator | Behavioral: Primer postcard, Behavioral: Behavioral theory-informed recruitment letter, Behavioral: 2 phone callsMailed a priming postcard, followed by a prospect theory-informed recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing |
| No postcard/behavioral letter/2 calls | Active comparator | Behavioral: Behavioral theory-informed recruitment letter, Behavioral: 2 phone callsMailed a prospect theory-informed recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing |
| Postcard/control letter/2 calls | Active comparator | Behavioral: Primer postcard, Behavioral: Control recruitment letter, Behavioral: 2 phone callsMailed a priming postcard, followed by a usual care control recruitment letter, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing |
| No postcare/control letter/2 calls | Active comparator | Behavioral: Control recruitment letter, Behavioral: 2 phone callsMailed a usual care control recruitment letter that is not preceded by a priming postcard, followed by up to 2 phone call attempts to schedule patient to attend an adherence counseling session with a clinical pharmacist trained in brief negotiated interviewing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Receive care at a Columbia-affiliated primary care clinic in the Ambulatory Care Network
- Diagnosis of hypertension
- Office BP >=140/90 mmHg at most recent office visit
- Prescribed at least one blood pressure medication
Key exclusion criteria (2 listed)
- Do not speak English or Spanish
- Pregnancy, dementia or terminal conditions as per ICD-10 codes
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 |
|---|---|---|
| Primer postcardMailed primer postcard | Behavioural | Postcard/behavioral letter/2 calls, Postcard/behavioral letter/4 calls, Postcard/control letter/2 calls, Postcard/control letter/4 calls |
| Control recruitment letterMailed recruitment letter with usual care message framing | Behavioural | No postcard/control letter/4 calls, No postcare/control letter/2 calls, Postcard/control letter/2 calls, Postcard/control letter/4 calls |
| Behavioral theory-informed recruitment letterMailed recruitment letter with prospect-theory informed message framing | Behavioural | No postcard/behavioral letter/2 calls, No postcard/behavioral letter/4 calls, Postcard/behavioral letter/2 calls, Postcard/behavioral letter/4 calls |
| 2 phone callsUp to 2 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit | Behavioural | No postcard/behavioral letter/2 calls, No postcare/control letter/2 calls, Postcard/behavioral letter/2 calls, Postcard/control letter/2 calls |
| 4 phone callsUp to 4 phone call attempts to schedule patient for a clinical pharmacist adherence counseling visit | Behavioural | No postcard/behavioral letter/4 calls, No postcard/control letter/4 calls, Postcard/behavioral letter/4 calls, Postcard/control letter/4 calls |
Primary outcome
Number of participants who completed an adherence counseling session
Time frame: 12 weeks
Measures patient attendance at a single adherence counseling session
5 secondary outcomes
Number of participants who scheduled an adherence counseling session
Time frame: 12 weeks
Number of days that participants were adherent to blood pressure medication
Time frame: 12 weeks
Number of days that participants were adherent to statin medication
Time frame: 12 weeks
Systolic blood pressure
Time frame: 12 weeks
Diastolic blood pressure
Time frame: 12 weeks
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 9 Dec 2025.
- Individual participant dataSharing planned: Yes. We plan to make available a de-identified database upon request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primer postcard, Behavioral theory-informed recruitment letter and 2 phone calls in people with Uncontrolled Hypertension, run by Columbia University at 1 site in United States.
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 6 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: enrolling by invitation, as of the sponsor's last update on 9 Dec 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 United States. 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?
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?
Number of participants who completed an adherence counseling session (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2025.