COPDCAPRINCT03794921
COPD Access to Pulmonary Rehabilitation Intervention
A study testing Every Step Counts in people with COPD, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Persons with COPD have significant functional disability but cannot access rehabilitative treatment at hospital-based conventional pulmonary rehabilitation (PR) programs. This project will determine whether an Internet-mediated, pedometer-based walking program can increase physical activity in persons with COPD who… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Every Step Counts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2019to 10 Sep 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, greater than or equal to 40 years of age
- Clinical diagnosis of COPD defined as: 1 of the following as testing-based evidence of COPD (any documented FEV1/FVC < 0.70, chest CT evidence of emphysema) AND at least 2 of the following as clinical evidence of COPD (≥ 10 pack-year cigarette smoking history, taking an antimuscarinic inhaler such as ipratropium or tiotropium, diagnosis of COPD written in a provider's note or on problem list)
- Have declined participation in a conventional pulmonary rehabilitation program
- Medical clearance from healthcare provider to participate in an exercise program
- Have Internet connection and Bluetooth capability, and access to video platform Cisco Webex#
- Answer yes to "Does your shortness of breath interfere with your functioning?"
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- Answer no to "Are you interested in joining PR now? If they answer yes, they will be ineligible and the PI will place a consult to PR for further evaluation
- Competent to provide informed consent
- Willingness to make return visits and be available by telephone for duration of study
Who cannot join
- COPD exacerbation in the previous 1 month
- Prescribed supplemental oxygen for activity+
- Inability to ambulate with or without assistance
- Use of assistive device for walking such as cane or walker*
- Inability to complete questionnaires
- Inability to collect at least 7 of 10 days of baseline step counts
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- Participation in a pulmonary rehabilitation program at time of screening or within the previous 3 months
- Participation in another exercise-related research study at time of screening
- Plans to participate in an exercise-related research study in the next 3 months
- Average baseline step counts of greater than or equal to 10,000 steps per week
- For those who wish to participate virtually.
- If participant has an in-person visit, oxygen will be assessed during the 6MWT to determine if subject's oxygen is stable during activity. If a participant has an in-person visit and oxygen is documented during the 6MWT and stays above 85%, he/she will be eligible to participate.
- If a participant uses an assistive walking device but we have previously shown that the Fitbit pedometer is accurate in him/her (before the study was transitioned to virtual) he/she will be allowed to participate in the study. If a participant has an in-person visit and Fitbit accuracy is documented during use of the assistive device he/she will be eligible to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
Official title: Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans With COPD
Persons with COPD have significant functional disability but cannot access rehabilitative treatment at hospital-based conventional pulmonary rehabilitation (PR) programs. This project will determine whether an Internet-mediated, pedometer-based walking program can increase physical activity in persons with COPD who qualify for but cannot access PR, compared to usual care. This proposal has high potential to deliver an immediate solution to a pressing clinical need. The proposed research addresses Rehabilitation R\&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.
Read the detailed description
Conventional pulmonary rehabilitation (PR) programs are highly effective and the standard of care in patients with chronic obstructive pulmonary disease (COPD). PR faces two significant problems: (1) most patients with COPD who would benefit from PR cannot access it, and 2) there is no effective long-term strategy to maintain physical activity (PA) and benefits after completing PR. The investigators propose a randomized controlled trial (RCT) to test the efficacy of a technology-mediated intervention to increase PA in persons with COPD who qualify for but cannot access conventional, hospital-based PR. COPD is a leading cause of death in the United States; an estimated 16 million Americans have COPD. Despite maximal medical therapy, patients with COPD characteristically experience breathlessness, which leads to a downward spiral of sedentary behavior, physical inactivity, deconditioning, and functional disability. Low physical activity is associated with poor outcomes in COPD--increased risk of acute exacerbations, hospitalizations, and death, independent of lung function. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend regular PA for all patients with COPD. Conventional, supervised PR programs clearly reduce breathlessness, and improve health-related quality of life (HRQL) and exercise capacity. However, PR programs face significant challenges of access and adherence. The investigators developed Every Step Counts (ESC), a technology-mediated intervention based on the Behavioral Theory of Self-Regulation, to target sedentary behavior, promote PA, and alleviate deconditioning. ESC couples a website with a pedometer to directly monitor step counts. The website provides individualized step-count goals, iterative feedback, education on disease self-management, motivation, and an online community of social support. In two randomized studies in Veterans with COPD, the investigators demonstrated ESC's safety, feasibility, and efficacy to increase PA. Accessible via the internet and available at any time from home, ESC could be an ideal low-cost platform to address the limitations of conventional PR. The investigators hypothesize that ESC may be an efficacious strategy to promote PA in the many patients who cannot attend a PR program.
Primary Aim 1: Determine the efficacy of a web-based intervention, ESC, to increase PA (measured directly with an accelerometer and a questionnaire that assesses intensity), compared to usual care, in persons with COPD who are referred to or eligible for conventional PR but who cannot access it.
Secondary Aim 2: Estimate the effect of the ESC intervention on (a) exercise self-efficacy, (b) HRQL, (c) dyspnea, (d) depression, and (e) risk of acute exacerbations and COPD-related hospitalizations, compared to usual care.
All study visits are performed either in-person or remotely starting September, 2021.
- Conditions
- COPD
- Being tested
- Every Step Counts
- Keywords
- Pulmonary Rehabilitation, Technology-Mediated, Web-Based Intervention, Physical Activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Every Step CountsOther
Pedometer coupled to a website that provides step-count goals, feedback, education, motivation, and social support.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises. |
| Every Step Counts Intervention | Experimental | Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Receives: Other: Every Step Counts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Measured as Change in Average Daily Step Count
Daily Step Count was directly measured with a wearable monitoring device. Change in daily step count at 12 weeks compared to baseline from the adjusted mixed model.
Measured: 12 weeks compared to baseline
Secondary outcomes (8)
Exercise Self-Regulatory Efficacy Measured as Change Score
Assessed by the Exercise Self-Regulatory Efficacy Scale questionnaire. 16-item questionnaire. Participants indicate their confidence level from 0% (not at all confident) to 100% (highly confident). Change in EX-SRES score at 12 weeks compared to baseline from the adjusted mixed model.
Measured: 12 weeks compared to baseline
Disease Specific Health-Related Quality of Life Measured as Change Score
Assessed by the St. George's Respiratory Questionnaire. The investigators will use the Total Score which ranges from 0 to 100, with lower scores representing better health related quality of life. Change in total score at 12 weeks compared to baseline from the adjusted mixed model.
Measured: 12 weeks compared to baseline
Shortness of Breath Rating as Perceived by the Participant Measured as Change Score
The modified Medical Research Council (mMRC) dyspnea scale ranges from 0 to 4, with higher numbers representing more shortness of breath. Change at 12 weeks compared to baseline from the adjusted mixed model.
Measured: 12 weeks compared to baseline
Depression Self-reported on Questionnaire Measured as Change Score
Depression measured by the Beck's Depression Inventory-II questionnaire. 21-items. Scores range with 0 to 63 with higher scores representing greater severity of depression. Change in score at 12 weeks compared to baseline from the adjusted mixed model.
Measured: 12 weeks compared to baseline
CHAMPS Physical Activity Questionnaire Measured as Change Score
Self-reported PA will be assessed with The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity questionnaire, a 41-item measure of the frequency and duration of PA over a typical week over the past four weeks that is used to calculate estimated caloric expenditure per week. Change in score at 12 weeks compared to baseline from the adjusted mixed model.
Measured: 12 weeks compared to baseline
Rapid Assessment of Physical Activity (RAPA) Questionnaire
Self-reported physical activity intensity was measured with the 7-item Rapid Assessment of PA (RAPA) questionnaire. Levels placed into three categories based on the highest physical activity level affirmatively endorsed: sedentary (score=1), underactive (score=2-5), and active (score >6) at 12 weeks compared to baseline.
Measured: 12 weeks compared to baseline
Healthcare Utilization Represented by Number of Hospitalizations Over Timeframe
Hospitalization History. Assessment of total number of all cause hospitalizations over the timeframe of 12 weeks based on self-report.
Measured: 12 weeks
Healthcare Utilization Represented by Number of Acute Exacerbations Over Timeframe
Acute Exacerbation History. Assessment of total number of acute exacerbations (AEs) over the timeframe of 12 weeks based on self-report.
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 posted7 Jan 2019
- Study start17 Sep 2019
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
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.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- As the primary aim, the investigators propose a RCT to study the efficacy of a web-based, pedometer-mediated physical activity intervention to increase physical activity in persons with COPD who would benefit from but cannot access conventional pulmonary rehabilitation, compared to usual care. The investigators anticipate that 120 subjects will be randomized 1:1 to either the intervention or usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marilyn L. Moy, MD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794921
- Sponsor's protocol ID
- F2855-R
- Other IDs
- I01RX002855
- Acronym
- CAPRI
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2018
- Last updated
- 2 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. * A local privacy officer will certify that a dataset contains no Protected Health Information (PHI), Personally Identifiable Information (PII), or VA Sensitive Information prior to release outside VA. * Final data sets will be maintained locally on a secure server or comparable data storage appliance inside the VA network until enterprise-level resources become available for long-term storage and access. The PI will create de-identified, study-specific datasets. Investigators requesting a copy of a dataset will sign a Letter of Agreement or a Data Use Agreement. A local privacy officer will certify that a dataset contains no PHI, PII, or VA Sensitive Information prior to release outside VA.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans With COPD
- ClinicalTrials.gov ID
- NCT03794921
- Acronym / sponsor ID
- CAPRI / F2855-R
- Conditions
- COPD
- Keywords
- Pulmonary Rehabilitation, Technology-Mediated, Web-Based Intervention, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Posted 2 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persons with COPD have significant functional disability but cannot access rehabilitative treatment at hospital-based conventional pulmonary rehabilitation (PR) programs. This project will determine whether an Internet-mediated, pedometer-based walking program can increase physical activity in persons with COPD who qualify for but cannot access PR, compared to usual care. This proposal has high potential to deliver an immediate solution to a pressing clinical need. The proposed research addresses Rehabilitation R\&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.
Detailed description
Conventional pulmonary rehabilitation (PR) programs are highly effective and the standard of care in patients with chronic obstructive pulmonary disease (COPD). PR faces two significant problems: (1) most patients with COPD who would benefit from PR cannot access it, and 2) there is no effective long-term strategy to maintain physical activity (PA) and benefits after completing PR. The investigators propose a randomized controlled trial (RCT) to test the efficacy of a technology-mediated intervention to increase PA in persons with COPD who qualify for but cannot access conventional, hospital-based PR. COPD is a leading cause of death in the United States; an estimated 16 million Americans have COPD. Despite maximal medical therapy, patients with COPD characteristically experience breathlessness, which leads to a downward spiral of sedentary behavior, physical inactivity, deconditioning, and functional disability. Low physical activity is associated with poor outcomes in COPD--increased risk of acute exacerbations, hospitalizations, and death, independent of lung function. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend regular PA for all patients with COPD. Conventional, supervised PR programs clearly reduce breathlessness, and improve health-related quality of life (HRQL) and exercise capacity. However, PR programs face significant challenges of access and adherence. The investigators developed Every Step Counts (ESC), a technology-mediated intervention based on the Behavioral Theory of Self-Regulation, to target sedentary behavior, promote PA, and alleviate deconditioning. ESC couples a website with a pedometer to directly monitor step counts. The website provides individualized step-count goals, iterative feedback, education on disease self-management, motivation, and an online community of social support. In two randomized studies in Veterans with COPD, the investigators demonstrated ESC's safety, feasibility, and efficacy to increase PA. Accessible via the internet and available at any time from home, ESC could be an ideal low-cost platform to address the limitations of conventional PR. The investigators hypothesize that ESC may be an efficacious strategy to promote PA in the many patients who cannot attend a PR program.
Primary Aim 1: Determine the efficacy of a web-based intervention, ESC, to increase PA (measured directly with an accelerometer and a questionnaire that assesses intensity), compared to usual care, in persons with COPD who are referred to or eligible for conventional PR but who cannot access it.
Secondary Aim 2: Estimate the effect of the ESC intervention on (a) exercise self-efficacy, (b) HRQL, (c) dyspnea, (d) depression, and (e) risk of acute exacerbations and COPD-related hospitalizations, compared to usual care.
All study visits are performed either in-person or remotely starting September, 2021.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- As the primary aim, the investigators propose a RCT to study the efficacy of a web-based, pedometer-mediated physical activity intervention to increase physical activity in persons with COPD who would benefit from but cannot access conventional pulmonary rehabilitation, compared to usual care. The investigators anticipate that 120 subjects will be randomized 1:1 to either the intervention or usual care.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises. |
| Every Step Counts Intervention | Experimental | Other: Every Step CountsPatients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects, greater than or equal to 40 years of age
- Clinical diagnosis of COPD defined as: 1 of the following as testing-based evidence of COPD (any documented FEV1/FVC < 0.70, chest CT evidence of emphysema) AND at least 2 of the following as clinical evidence of COPD (≥ 10 pack-year cigarette smoking history, taking an antimuscarinic inhaler such as ipratropium or tiotropium, diagnosis of COPD written in a provider's note or on problem list)
- Have declined participation in a conventional pulmonary rehabilitation program
- Medical clearance from healthcare provider to participate in an exercise program
- Have Internet connection and Bluetooth capability, and access to video platform Cisco Webex#
Key exclusion criteria (13 listed)
- COPD exacerbation in the previous 1 month
- Prescribed supplemental oxygen for activity+
- Inability to ambulate with or without assistance
- Use of assistive device for walking such as cane or walker*
- Inability to complete questionnaires
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 |
|---|---|---|
| Every Step CountsPedometer coupled to a website that provides step-count goals, feedback, education, motivation, and social support. | Other | Every Step Counts Intervention |
Primary outcome
Physical Activity Measured as Change in Average Daily Step Count
Time frame: 12 weeks compared to baseline
Daily Step Count was directly measured with a wearable monitoring device. Change in daily step count at 12 weeks compared to baseline from the adjusted mixed model.
8 secondary outcomes
Exercise Self-Regulatory Efficacy Measured as Change Score
Time frame: 12 weeks compared to baseline
Disease Specific Health-Related Quality of Life Measured as Change Score
Time frame: 12 weeks compared to baseline
Shortness of Breath Rating as Perceived by the Participant Measured as Change Score
Time frame: 12 weeks compared to baseline
Depression Self-reported on Questionnaire Measured as Change Score
Time frame: 12 weeks compared to baseline
CHAMPS Physical Activity Questionnaire Measured as Change Score
Time frame: 12 weeks compared to baseline
Rapid Assessment of Physical Activity (RAPA) Questionnaire
Time frame: 12 weeks compared to baseline
Healthcare Utilization Represented by Number of Hospitalizations Over Timeframe
Time frame: 12 weeks
Healthcare Utilization Represented by Number of Acute Exacerbations Over Timeframe
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. * A local privacy officer will certify that a dataset contains no Protected Health Information (PHI), Personally Identifiable Information (PII), or VA Sensitive Information prior to release outside VA. * Final data sets will be maintained locally on a secure server or comparable data storage appliance inside the VA network until enterprise-level resources become available for long-term storage and access. The PI will create de-identified, study-specific datasets. Investigators requesting a copy of a dataset will sign a Letter of Agreement or a Data Use Agreement. A local privacy officer will certify that a dataset contains no PHI, PII, or VA Sensitive Information prior to release outside VA.
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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.
Marilyn L. Moy, MD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Every Step Counts in people with COPD, run by VA Office of Research and Development 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 9 inclusion and 13 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 2 Apr 2026. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2026). 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?
Physical Activity Measured as Change in Average Daily Step Count (time frame: 12 weeks compared to baseline). 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 2 Apr 2026.