Stroke (CVA) or TIAMOSESNCT05780060
Multiple Organized Systems for Engaging Stroke (MOSES)
A study of Stroke (CVA) or TIA, run by Montefiore Medical Center.
Trial summary
Despite decades of national declines in stroke incidence, racial/ethnic and socioeconomic disparities in stroke prevalence and care remain pervasive and the gap in these disparities is widening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke (CVA) or TIA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of recent TIA (<6 months) or minor stroke
- discharged to home with stroke clinic follow up planned
- modified Rankin score <3 at time of discharge.
Who cannot join
- Cognitive impairment limiting compliance with the intervention
- Modified Rankin score >2
About this study
Despite decades of national declines in stroke incidence, racial/ethnic and socioeconomic disparities in stroke prevalence and care remain pervasive and the gap in these disparities is widening. Those who identify as African American (AA) or Hispanic are 2-3 times more likely to have a stroke when compared to those who identify as non-Hispanic White (NHW) and are also less likely to receive guideline-based medical therapy (e.g. mechanical thrombectomy, intravenous thrombolysis, discharge antithrombotic/anticoagulant, smoking cessation education) after their stroke. Additionally, people living in underserved communities with high local social deprivation indices and decreased community-level healthcare access, have an increased population-level risk of stroke. These inequities are likely multi-factorial and in large part related to decreased access to health promotion and preventive care services, as well as social/economic constraints impeding patients' access and compliance with medical treatment recommendations. Innovations in patient-facing digital health technologies, such as telemedicine, remote patient monitoring (RPM), and patient-facing smart phone applications could help bridge the gaps in post stroke care in marginalized communities by providing more accessible, convenient and perhaps effective, health care services. A recent secondary stroke prevention trial with predominantly African American and Hispanic participants compared blood pressure control measured by RPM combined with telehealth support vs. standard office-based follow up and found improved adherence and risk factor control in the digitally assisted group. However, there is limited knowledge around the patient and provider-level barriers, and supportive and educational resources needed to translating these and other similar findings into practice, especially in high-risk communities. Importantly, the same barriers to adopting digitally assisted care delivery during transitions of care and in the management of high-risk groups are shared across a number of episodic (e.g. ACS), acute on chronic (e.g. asthma, COPD, heart failure, DKA) and chronic diseases (e.g. hypertension, renal failure).
Read the detailed description
Studying the implementation and uptake of technology based interventions (TBIs) after acute stroke hospitalization, may offer an ideal touch point to better understanding common translational bottlenecks to adopting TBIs across a number of other healthcare settings. Multiple Organized Systems for Engaging Stroke (MOSES) will employ a pragmatic comparative effectiveness design to study standard stroke clinic follow up combined with RPM for blood pressure management and compare it to standard clinic follow, RPM and an added patient-facing smartphone application with educational modules and adherence incentives. The investigator team hypothesizes that combining RPM with a patient-facing application consisting of treatment adherence reminders, digital education and digital incentives, will lead to improved care delivery and better compliance. Additionally, patient and user-centered outcomes, as well as perceived barriers to implementation by key stakeholders, will be studied. If successful, MOSES could improve the understanding of shared translational barriers related to implementation and uptake of TBIs in high-risk populations during transitions of care. Insights may also be applicable to the use of non blood pressure RPM, such as in digital scales, glucometers and sleep study devices. The investigator team plans to test this hypothesis and study patient-centered outcomes through the following two AIMS:
Specific Aims Aim1: To develop a culturally tailored patient facing application as an ancillary educational resource to using RPM and to aid with treatment plan adherence in the transition of care after acute stroke. In months 1-3, the study team plans to adapt a culturally tailored patient-facing smartphone application already being used in diabetes care (DiabetesXcel - developed by the research team at Montefiore-Einstein); to provide education on risk factor control strategies including use of RPM, treatment adherence push notification reminders, and digital incentives (gamification vs non-fungible tokens) in patients with recent hospitalization for acute stroke (secondary stroke prevention). Using a mixed methods approach feedback on the use of RPM and resources to be provided as part of a smart phone applications from 10 patients and 5 providers will be elicited, including potential unanticipated or undesirable effects. This patient and provider-centered analyses of TBIs (RPM, digitally delivered feedback regarding BP, digital incentives) will be performed in the Montefiore Comprehensive Stroke Center (CSC) clinic setting. Outcomes will include qualitative patient and provider experiences with the TBIs including barriers and facilitators to the use of RPM and patient-facing application in the study population. The investigator team hypothesizes that TBIs in the form of RPM and patient facing applications will be associated with a high level of patient and provider satisfaction.
Aim 2: To evaluate the impact of remote patient monitoring (RPM) and a patient-facing application on health outcomes in patients with recent TIA or minor stroke. In months 4-10, the investigator team will conduct a pragmatic comparative effectiveness study comparing standard stroke clinic follow up combined with RPM to aid with blood pressure management (n=30) versus standard stroke clinic follow, RPM and an added patient-facing smartphone application with educational modules and adherence incentives (n=30). Outcomes will include recruitment, retention and follow up metrics, self-reported adherence to medication regimens and life-style recommendations, patient engagement with RPM data and patient-facing application, cost-effectiveness of the interventions and changes in blood pressure as well as biomarkers such as HbA1c or LDL cholesterol levels. The study team hypothesizes that RPM combined with a patient-facing application will improve patient reported and clinical outcomes of interest in the post-stroke transition of care setting.
Approach Overall, the outcomes for each of the study aims will allow for a comprehensive understanding of the impact of RPM and a patient-facing application on health outcomes, as well as the barriers and facilitators to implementation and the feasibility and acceptability of the interventions in a high-risk inner-city community. The mixed methods framework and comparative effectiveness approach will allow for both a quantitative and qualitative understanding of the complexity of implementing the TBIs in this population. Specifically, the study team will conduct focus group sessions with 10 patients and 5 providers in the stroke clinic (NP, MDs, administrators) to gauge perceived digital health needs and value, as well as perceived barriers to TBI use. This values inventory-or the identification of where key beliefs and conceptions converge and diverge between these stakeholder groups is essential for avoiding unintended bias, unintended consequences, and can help advance the success of TBI interventions for preventative and chronic disease management. Further, the investigator team will conduct theory-informed formative and summative evaluation (e.g. perceived usefulness, ease of use) to aid in the understanding of the stakeholder's comfort and trust in various currently used and more novel TBIs including novel concepts and technologies which are increasingly influencing healthcare delivery (gamification, non-fungible tokens, smart contracts, machine learning, automation, decentralized autonomous organizations). The investigator team plans to use the information to improve functionality and usability of TBIs and to iteratively refine the RPM and patient facing application. To evaluate the process of TBI implementation in the Montefiore CSC clinic the study team will use the RE-AIM framework to assess the intervention's Reach (recruitment and retention rates, representativeness of the study sample),
- Conditions
- Stroke (CVA) or TIA
- Being tested
- Standard of care, RPM and digital feedback, Standard of care and RPM only
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care, RPM and digital feedbackBehavioural
Standard stroke follow up, RPM and a patient facing smartphone application containing real time BP feedback, educational models, treatment adherence push notification reminders, digital education and digital incentives (n=30). Outcomes will include recruitment, retention and follow up metrics, self-reported adherence to medication regimens and life-style recommendations, patient engagement with RPM data and patient-facing application, cost-effectiveness of the interventions and changes in blood pressure as well as biomarkers like LDL and Hemoglobin A1C.
Standard of care and RPM onlyBehavioural
Standard stroke clinic follow up and remote blood pressure monitoring (n=30). Outcomes will include qualitative patient and provider experiences with the TBIs including barriers and facilitators to the use of RPM and patient-facing application in the study population
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | standard stroke clinic follow, combined with remote patient blood pressure monitoring and an added patient-facing smartphone application with educational modules and adherence incentives (n=30). Receives: Behavioral: Standard of care, RPM and digital feedback |
| Control arm | Active comparator | standard stroke clinic follow up combined with remote blood pressure monitoring Receives: Behavioral: Standard of care and RPM only |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Telehealth Usability Questionnaire (TUQ) This is a 21 question survey which assesses 5 domains (usefulness, ease of use, reliability, effectiveness, satisfaction) of patient's satisfaction and usability of remote monitoring.
Each question is ranked from 1-7 with 7 defined as "strong agreement/satisfaction" Min score is 21, max score is 147. The higher the score the greater the satisfaction/usability
Measured: 1 month
provider satisfaction
Telehealth Usability Questionnaire (TUQ) This is a 21 question survey which assesses 5 domains (usefulness, ease of use, reliability, effectiveness, satisfaction) of a provider's satisfaction and usability of remote monitoring.
Each question is ranked from 1-7 with 7 defined as "strong agreement/satisfaction" Min score is 21, max score is 147 The higher the score the greater the satisfaction/usability
Measured: 1 month
compliance with medical follow up and treatment plan
defined by the number of telehealth visits over the course of the study Min is 0 and max is 10
Measured: 1 month
medical knowledge of stroke symptoms
ability to identify the symptoms of stroke defined by the BEFAST Criteria. Min is 0, max is score 6, with higher score defined as having greater medical knowledge of stroke symptoms
Measured: 1 month
Secondary outcomes (2)
BP control
the weekly average systolic, diastolic blood pressure, and mean arterial pressure over the course of the study. All weekly measures will be averaged. Any erroneous values that fall 2 standard deviations away from the mean will be excluded.
there is no min or max.
Measured: 1 month
readmission rate
readmission rate for stroke or other acute illness at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Why it stopped: Study did not get funded as anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke (CVA) or TIAStudies 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
- The study team will conduct a pragmatic comparative effectiveness study comparing standard stroke clinic follow up combined with RPM to aid with blood pressure management (n=30) versus standard stroke clinic follow, RPM and an added patient-facing smartphone application with educational modules and adherence incentives (n=30). Outcomes will include recruitment, retention and follow up metrics, self-reported adherence to medication regimens and life-style recommendations, patient engagement with RPM data and patient-facing application, cost-effectiveness of the interventions and changes in blood pressure as well as biomarkers such as HbA1c or LDL cholesterol levels. We hypothesize that RPM combined with a patient-facing application will improve patient reported and clinical outcomes of interest in the post-stroke transition of care setting.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Esenwa, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780060
- Sponsor's protocol ID
- 2021-13414
- Acronym
- MOSES
- Status last verified
- Apr 2023
- First submitted
- 17 Feb 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Organized Systems for Engaging Stroke (MOSES)
- ClinicalTrials.gov ID
- NCT05780060
- Acronym / sponsor ID
- MOSES / 2021-13414
- Conditions
- Stroke (CVA) or TIA
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not get funded as anticipated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 22 Mar 2023 (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.
Despite decades of national declines in stroke incidence, racial/ethnic and socioeconomic disparities in stroke prevalence and care remain pervasive and the gap in these disparities is widening. Those who identify as African American (AA) or Hispanic are 2-3 times more likely to have a stroke when compared to those who identify as non-Hispanic White (NHW) and are also less likely to receive guideline-based medical therapy (e.g. mechanical thrombectomy, intravenous thrombolysis, discharge antithrombotic/anticoagulant, smoking cessation education) after their stroke. Additionally, people living in underserved communities with high local social deprivation indices and decreased community-level healthcare access, have an increased population-level risk of stroke. These inequities are likely multi-factorial and in large part related to decreased access to health promotion and preventive care services, as well as social/economic constraints impeding patients' access and compliance with medical treatment recommendations. Innovations in patient-facing digital health technologies, such as telemedicine, remote patient monitoring (RPM), and patient-facing smart phone applications could help bridge the gaps in post stroke care in marginalized communities by providing more accessible, convenient and perhaps effective, health care services. A recent secondary stroke prevention trial with predominantly African American and Hispanic participants compared blood pressure control measured by RPM combined with telehealth support vs. standard office-based follow up and found improved adherence and risk factor control in the digitally assisted group. However, there is limited knowledge around the patient and provider-level barriers, and supportive and educational resources needed to translating these and other similar findings into practice, especially in high-risk communities. Importantly, the same barriers to adopting digitally assisted care delivery during transitions of care and in the management of high-risk groups are shared across a number of episodic (e.g. ACS), acute on chronic (e.g. asthma, COPD, heart failure, DKA) and chronic diseases (e.g. hypertension, renal failure).
Detailed description
Studying the implementation and uptake of technology based interventions (TBIs) after acute stroke hospitalization, may offer an ideal touch point to better understanding common translational bottlenecks to adopting TBIs across a number of other healthcare settings. Multiple Organized Systems for Engaging Stroke (MOSES) will employ a pragmatic comparative effectiveness design to study standard stroke clinic follow up combined with RPM for blood pressure management and compare it to standard clinic follow, RPM and an added patient-facing smartphone application with educational modules and adherence incentives. The investigator team hypothesizes that combining RPM with a patient-facing application consisting of treatment adherence reminders, digital education and digital incentives, will lead to improved care delivery and better compliance. Additionally, patient and user-centered outcomes, as well as perceived barriers to implementation by key stakeholders, will be studied. If successful, MOSES could improve the understanding of shared translational barriers related to implementation and uptake of TBIs in high-risk populations during transitions of care. Insights may also be applicable to the use of non blood pressure RPM, such as in digital scales, glucometers and sleep study devices. The investigator team plans to test this hypothesis and study patient-centered outcomes through the following two AIMS:
Specific Aims Aim1: To develop a culturally tailored patient facing application as an ancillary educational resource to using RPM and to aid with treatment plan adherence in the transition of care after acute stroke. In months 1-3, the study team plans to adapt a culturally tailored patient-facing smartphone application already being used in diabetes care (DiabetesXcel - developed by the research team at Montefiore-Einstein); to provide education on risk factor control strategies including use of RPM, treatment adherence push notification reminders, and digital incentives (gamification vs non-fungible tokens) in patients with recent hospitalization for acute stroke (secondary stroke prevention). Using a mixed methods approach feedback on the use of RPM and resources to be provided as part of a smart phone applications from 10 patients and 5 providers will be elicited, including potential unanticipated or undesirable effects. This patient and provider-centered analyses of TBIs (RPM, digitally delivered feedback regarding BP, digital incentives) will be performed in the Montefiore Comprehensive Stroke Center (CSC) clinic setting. Outcomes will include qualitative patient and provider experiences with the TBIs including barriers and facilitators to the use of RPM and patient-facing application in the study population. The investigator team hypothesizes that TBIs in the form of RPM and patient facing applications will be associated with a high level of patient and provider satisfaction.
Aim 2: To evaluate the impact of remote patient monitoring (RPM) and a patient-facing application on health outcomes in patients with recent TIA or minor stroke. In months 4-10, the investigator team will conduct a pragmatic comparative effectiveness study comparing standard stroke clinic follow up combined with RPM to aid with blood pressure management (n=30) versus standard stroke clinic follow, RPM and an added patient-facing smartphone application with educational modules and adherence incentives (n=30). Outcomes will include recruitment, retention and follow up metrics, self-reported adherence to medication regimens and life-style recommendations, patient engagement with RPM data and patient-facing application, cost-effectiveness of the interventions and changes in blood pressure as well as biomarkers such as HbA1c or LDL cholesterol levels. The study team hypothesizes that RPM combined with a patient-facing application will improve patient reported and clinical outcomes of interest in the post-stroke transition of care setting.
Approach Overall, the outcomes for each of the study aims will allow for a comprehensive understanding of the impact of RPM and a patient-facing application on health outcomes, as well as the barriers and facilitators to implementation and the feasibility and acceptability of the interventions in a high-risk inner-city community. The mixed methods framework and comparative effectiveness approach will allow for both a quantitative and qualitative understanding of the complexity of implementing the TBIs in this population. Specifically, the study team will conduct focus group sessions with 10 patients and 5 providers in the stroke clinic (NP, MDs, administrators) to gauge perceived digital health needs and value, as well as perceived barriers to TBI use. This values inventory-or the identification of where key beliefs and conceptions converge and diverge between these stakeholder groups is essential for avoiding unintended bias, unintended consequences, and can help advance the success of TBI interventions for preventative and chronic disease management. Further, the investigator team will conduct theory-informed formative and summative evaluation (e.g. perceived usefulness, ease of use) to aid in the understanding of the stakeholder's comfort and trust in various currently used and more novel TBIs including novel concepts and technologies which are increasingly influencing healthcare delivery (gamification, non-fungible tokens, smart contracts, machine learning, automation, decentralized autonomous organizations). The investigator team plans to use the information to improve functionality and usability of TBIs and to iteratively refine the RPM and patient facing application. To evaluate the process of TBI implementation in the Montefiore CSC clinic the study team will use the RE-AIM framework to assess the intervention's Reach (recruitment and retention rates, representativeness of the study sample),
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study team will conduct a pragmatic comparative effectiveness study comparing standard stroke clinic follow up combined with RPM to aid with blood pressure management (n=30) versus standard stroke clinic follow, RPM and an added patient-facing smartphone application with educational modules and adherence incentives (n=30). Outcomes will include recruitment, retention and follow up metrics, self-reported adherence to medication regimens and life-style recommendations, patient engagement with RPM data and patient-facing application, cost-effectiveness of the interventions and changes in blood pressure as well as biomarkers such as HbA1c or LDL cholesterol levels. We hypothesize that RPM combined with a patient-facing application will improve patient reported and clinical outcomes of interest in the post-stroke transition of care setting.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Standard of care, RPM and digital feedbackstandard stroke clinic follow, combined with remote patient blood pressure monitoring and an added patient-facing smartphone application with educational modules and adherence incentives (n=30). |
| Control arm | Active comparator | Behavioral: Standard of care and RPM onlystandard stroke clinic follow up combined with remote blood pressure monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of recent TIA (<6 months) or minor stroke
- discharged to home with stroke clinic follow up planned
- modified Rankin score <3 at time of discharge.
Key exclusion criteria (2 listed)
- Cognitive impairment limiting compliance with the intervention
- Modified Rankin score >2
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 |
|---|---|---|
| Standard of care, RPM and digital feedbackStandard stroke follow up, RPM and a patient facing smartphone application containing real time BP feedback, educational models, treatment adherence push notification reminders, digital education and digital incentives (n=30). Outcomes will include recruitment, retention and follow up metrics, self-reported adherence to medication regimens and life-style recommendations, patient engagement with RPM data and patient-facing application, cost-effectiveness of the interventions and changes in blood pressure as well as biomarkers like LDL and Hemoglobin A1C. | Behavioural | Intervention arm |
| Standard of care and RPM onlyStandard stroke clinic follow up and remote blood pressure monitoring (n=30). Outcomes will include qualitative patient and provider experiences with the TBIs including barriers and facilitators to the use of RPM and patient-facing application in the study population | Behavioural | Control arm |
Primary outcome
patient satisfaction
Time frame: 1 month
Telehealth Usability Questionnaire (TUQ) This is a 21 question survey which assesses 5 domains (usefulness, ease of use, reliability, effectiveness, satisfaction) of patient's satisfaction and usability of remote monitoring. Each question is ranked from 1-7 with 7 defined as "strong agreement/satisfaction" Min score is 21, max score is 147. The higher the score the greater the satisfaction/usability
provider satisfaction
Time frame: 1 month
Telehealth Usability Questionnaire (TUQ) This is a 21 question survey which assesses 5 domains (usefulness, ease of use, reliability, effectiveness, satisfaction) of a provider's satisfaction and usability of remote monitoring. Each question is ranked from 1-7 with 7 defined as "strong agreement/satisfaction" Min score is 21, max score is 147 The higher the score the greater the satisfaction/usability
compliance with medical follow up and treatment plan
Time frame: 1 month
defined by the number of telehealth visits over the course of the study Min is 0 and max is 10
medical knowledge of stroke symptoms
Time frame: 1 month
ability to identify the symptoms of stroke defined by the BEFAST Criteria. Min is 0, max is score 6, with higher score defined as having greater medical knowledge of stroke symptoms
2 secondary outcomes
BP control
Time frame: 1 month
readmission rate
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Charles Esenwa, MD principal investigator
Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
A study of Stroke (CVA) or TIA, run by Montefiore Medical Center.
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 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: withdrawn, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
patient satisfaction (time frame: 1 month). The study lists 4 primary outcomes in all. 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 13 Apr 2023.