Liver DiseasesCOMPASSNCT03022630
Palliative Care for Non-Malignant Diseases (COMPASS Trial)
A study testing Comprehensive Palliative Care services and Usual hepatic care in people with Liver Diseases and Liver Cirrhosis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Liver Cirrhosis, NASH (Non-Alcoholic Steatohepatitis)
- What is being tested?
- Comprehensive Palliative Care services and Usual hepatic care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 21 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient at Vanderbilt University Medical Center with advanced cirrhotic liver disease, whose treating hepatologist indicates a 'No' response to the question, "Would you be surprised if this patient died within 1 year?"
Who cannot join
- Age < 18 years
- Receipt of liver transplant at the time of potential enrollment
- Inability to give written informed consent (patient or surrogate decision-maker)
- Inability to respond to questions in English
- Treating hepatologist denies permission to enroll
- Receiving hepatology care at non-Vanderbilt sites (to ensure appropriate follow-up)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: The Creation of Models for Palliative Assessments to Support Severe Illness (COMPASS) Investigation: Testing Early and Ongoing Implementation of Palliative Care for Incurable Non-malignant Diseases
The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The intervention includes comprehensive, standardized palliative care services for adult hepatology cirrhosis patients for which prognosis is poor.
Read the detailed description
Palliative care is specialized medical care focused on providing patients with relief from the symptoms, pain, and stress of serious or life-limiting illness, regardless of diagnosis, by anticipating, preventing, and treating suffering. Palliative care aims to provide patients and their families with services to help patients make the best possible medical decisions in the face of serious illness. Unfortunately it is often thought to be synonymous with hospice care and therefore underutilized as a part of standard care. Patients with chronic liver disease or cirrhosis may be a particularly underserved population for palliative care, as palliative care may be disregarded until hope of liver transplantation is lost.
Study Description:
- Adult patients admitted to Vanderbilt University Medical Center with cirrhotic advanced liver disease and poor prognosis will be randomized to receive either usual hepatic care or usual hepatic care with comprehensive palliative care services.
- Participants randomized to the intervention arm will receive patient-friendly informational materials, a comprehensive initial palliative care consultation, and follow-up consultations while inpatient. After discharge from hospital, follow-up consults will occur via telephone contact. Telephone contacts will occur on a flexible schedule based on needs and wishes of the participant at a minimum frequency of one contact per month.
- Participants will receive the palliative care intervention for at least 1 year after randomization to the intervention arm or until death.
- Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a meeting is requested by the patient, the family, or treating physician. These consultations include the same palliative care services as the intervention arm, excluding the telephone follow-up consultations.
- All participants will complete quality of life, mood, and satisfaction with care assessments at specified time points for 1 year after randomization or until death. Optional caregiver participation includes completion of satisfaction with care assessments.
Specific aims include:
- Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on time to first hospital readmission within 1-year post randomization.
- Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on other hospital utilization, including days alive out of hospital within 6- months post randomization, total days in hospital (and ICU) within 1-year post randomization, number and cost of hospital admissions within 1-year post randomization, median length of stay per admission, transfers and time to hospice placement, and survival within 1-year post randomization.
- Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on qualify of life.
- Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on patient/caregiver satisfaction.
- Evaluate the fidelity of the palliative care intervention and assess the generalizability of implementing a large-scale Palliative Care program.
- Being tested
- Comprehensive Palliative Care services, Usual hepatic care
- Keywords
- palliative care, cirrhosis, liver disease, hepatology, end of life care, supportive care
- Medical subject headings
- Liver Diseases, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Palliative Care servicesOther
Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.
Usual hepatic careOther
Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Palliative Care services | Other | Comprehensive Palliative Care services in addition to usual hepatic care Receives: Other: Comprehensive Palliative Care services |
| Usual hepatic care | Other | Usual hepatic care Receives: Other: Usual hepatic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Hospital Readmission Within 6 Months Post-randomization
Assess the impact of palliative care services on time to first hospital readmission.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Secondary outcomes (21)
Days Alive Out of Hospital
Days alive out of hospital from randomization to 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Total Days in Hospital
Total days in hospital from randomization to 6 months post randomization compared across arms Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Total Days in ICU
Total days in ICU from randomization to 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Number of Hospital Readmissions
Number of hospital readmissions from randomization to 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Median Length of Hospital Stay Per Admission
Median length of hospital stay per admission from randomization to 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Hospice Referral
Number of transfers to hospice within 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Time to Hospice Placement
Number of days from hospice referral to time to hospice placement. Time frame was changed from 1 year to 6 months due to early termination. There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.
Measured: 6 months post-randomization
Change in Chronic Liver Disease Questionnaire (CLDQ)
Change in liver disease-related quality of life: The CLDQ is a 29-item questionnaire measuring 6 domains. Item scores range from 1 to 7 with higher scores indicating better quality of life. The total score can range from 29 to 203 with a score of 1 meaning the symptom being assessed is "present always" while a score of 7 means the symptom is "never present". Therefore, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. The questions in each domain have a range of factor loads indicative of their impact, and a clinically important difference is defined as a score change of 0.5.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: Change from baseline over 6 months post-randomization
Change in EQ-5D-5L
Change in generic health status: The EQ-5D-5L is a 5-item questionnaire with responses ranging from absence of symptom to extreme experience of the symptom. This scale is numbered from 0 to 100. 100 means the best health you can imagine and 0 means the worst health you can imagine.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: Change from baseline over 6 months post-randomization
Change in PROMIS Emotional Distress - Anxiety - Short Form 4a
Change in mood (anxiety): The PROMIS Emotional Distress - Anxiety - Short Form 4a contains 4 items that measure anxiety on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score can range from 4 to 20 which converts to a t-score range of 40.3 to 81.6.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: Change from baseline over 6 months post-randomization
Change in PROMIS Emotional Distress - Depression - Short Form 4a
Change in mood (depression): The PROMIS Emotional Distress - Depression - Short Form 4a contains 4 items that measure depression on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score ranges from 4 to 20 which converts to a t-score range of 41.0 to 79.4.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: Change from baseline over 6 months post-randomization
Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient)
Change in patient satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better satisfaction with care. The score can range from 0 to 110.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: Change from baseline over 6 months post-randomization
Change in Kingston Caregiver Stress Scale
The Kingston Caregiver Stress Scale will be used to measure caregiver stress. The KCSS is designed to measure stress experienced by lay caregivers, not institutional staff, and was designed to monitor change in an individuals stress over time. Ten items are grouped into three categories: care giving, family, and financial issues. Scores can range from 10 to 50. Lower scores indicate less stress and higher scores indicate high stress.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: Change from baseline over 6 months post-randomization
Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver)
Change in caregiver satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient item wording was modified to apply to caregivers. The questionnaire is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better quality of care. The score can range from 0 to 110.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: Change from baseline over 6 months post-randomization
Liver Transplant Status
Number of deferred, listed, and declined listing for liver transplant compared across arms.
Time frame was changed from 1 year to 6 months due to early termination. Liver transplant status data was not obtained.
Measured: 6 months post-randomization
Model for End-Stage Liver Disease (MELD) Score
Baseline MELD score compared across arms. MELD score ranks the participants degree of sickness and indicates how much the participant needs a liver transplant. The score ranges from 6-40. The higher the number the more urgent the need for a transplant.
Measured: Baseline
Completed Liver Transplants
Number of patients with completed liver transplants compared across arms. Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Physical Symptoms
Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms.
Time frame was changed from 1 year to 6 months due to early termination. Physical symptom data was not obtained.
Measured: 6 months post-randomization
Presence of Advance Directives
Percentage of patients with documented advance care directives compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Survival
Survival rate compared across arms. Time frame was changed from 1 year to 6 months due to early termination.
Measured: 6 months post-randomization
Provider Satisfaction
The "ICU Provider Satisfaction Survey with the Palliative Care Program:Veterans Affairs of Ann Arbor" instrument is available online and has been modified for the current study by removing the 'ICU' reference and revising 'pain' to symptoms more relevant to the current population. The survey includes 7-item questionnaire, with items scored on a 5-point Likert type scale with higher scores indicating better provider satisfaction. The score can range from 0 to 35.
Time frame was changed due to early termination. Data was not collected.
Measured: Change from Baseline to study closeout.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start6 Feb 2017
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Why it stopped: slow enrollment
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 Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gordon Bernard, Vanderbilt University Medical Center
- Investigators
- Gordon Bernard, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022630
- Sponsor's protocol ID
- 160746
- Acronym
- COMPASS
- Status last verified
- Aug 2019
- First submitted
- 3 Jun 2016
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Creation of Models for Palliative Assessments to Support Severe Illness (COMPASS) Investigation: Testing Early and Ongoing Implementation of Palliative Care for Incurable Non-malignant Diseases
- ClinicalTrials.gov ID
- NCT03022630
- Acronym / sponsor ID
- COMPASS / 160746
- Keywords
- palliative care, cirrhosis, liver disease, hepatology, end of life care, supportive care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 22 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The intervention includes comprehensive, standardized palliative care services for adult hepatology cirrhosis patients for which prognosis is poor.
Detailed description
Palliative care is specialized medical care focused on providing patients with relief from the symptoms, pain, and stress of serious or life-limiting illness, regardless of diagnosis, by anticipating, preventing, and treating suffering. Palliative care aims to provide patients and their families with services to help patients make the best possible medical decisions in the face of serious illness. Unfortunately it is often thought to be synonymous with hospice care and therefore underutilized as a part of standard care. Patients with chronic liver disease or cirrhosis may be a particularly underserved population for palliative care, as palliative care may be disregarded until hope of liver transplantation is lost.
Study Description:
- Adult patients admitted to Vanderbilt University Medical Center with cirrhotic advanced liver disease and poor prognosis will be randomized to receive either usual hepatic care or usual hepatic care with comprehensive palliative care services.
- Participants randomized to the intervention arm will receive patient-friendly informational materials, a comprehensive initial palliative care consultation, and follow-up consultations while inpatient. After discharge from hospital, follow-up consults will occur via telephone contact. Telephone contacts will occur on a flexible schedule based on needs and wishes of the participant at a minimum frequency of one contact per month.
- Participants will receive the palliative care intervention for at least 1 year after randomization to the intervention arm or until death.
- Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a meeting is requested by the patient, the family, or treating physician. These consultations include the same palliative care services as the intervention arm, excluding the telephone follow-up consultations.
- All participants will complete quality of life, mood, and satisfaction with care assessments at specified time points for 1 year after randomization or until death. Optional caregiver participation includes completion of satisfaction with care assessments.
Specific aims include:
- Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on time to first hospital readmission within 1-year post randomization.
- Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on other hospital utilization, including days alive out of hospital within 6- months post randomization, total days in hospital (and ICU) within 1-year post randomization, number and cost of hospital admissions within 1-year post randomization, median length of stay per admission, transfers and time to hospice placement, and survival within 1-year post randomization.
- Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on qualify of life.
- Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on patient/caregiver satisfaction.
- Evaluate the fidelity of the palliative care intervention and assess the generalizability of implementing a large-scale Palliative Care program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Palliative Care services | Other | Other: Comprehensive Palliative Care servicesComprehensive Palliative Care services in addition to usual hepatic care |
| Usual hepatic care | Other | Other: Usual hepatic careUsual hepatic care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inpatient at Vanderbilt University Medical Center with advanced cirrhotic liver disease, whose treating hepatologist indicates a 'No' response to the question, "Would you be surprised if this patient died within 1 year?"
Key exclusion criteria (6 listed)
- Age < 18 years
- Receipt of liver transplant at the time of potential enrollment
- Inability to give written informed consent (patient or surrogate decision-maker)
- Inability to respond to questions in English
- Treating hepatologist denies permission to enroll
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 |
|---|---|---|
| Comprehensive Palliative Care servicesParticipants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart. | Other | Comprehensive Palliative Care services |
| Usual hepatic careParticipants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations. | Other | Usual hepatic care |
Primary outcome
Time to First Hospital Readmission Within 6 Months Post-randomization
Time frame: 6 months post-randomization
Assess the impact of palliative care services on time to first hospital readmission. Time frame was changed from 1 year to 6 months due to early termination.
21 secondary outcomes
Days Alive Out of Hospital
Time frame: 6 months post-randomization
Total Days in Hospital
Time frame: 6 months post-randomization
Total Days in ICU
Time frame: 6 months post-randomization
Number of Hospital Readmissions
Time frame: 6 months post-randomization
Median Length of Hospital Stay Per Admission
Time frame: 6 months post-randomization
Hospice Referral
Time frame: 6 months post-randomization
Time to Hospice Placement
Time frame: 6 months post-randomization
Change in Chronic Liver Disease Questionnaire (CLDQ)
Time frame: Change from baseline over 6 months post-randomization
Change in EQ-5D-5L
Time frame: Change from baseline over 6 months post-randomization
Change in PROMIS Emotional Distress - Anxiety - Short Form 4a
Time frame: Change from baseline over 6 months post-randomization
Change in PROMIS Emotional Distress - Depression - Short Form 4a
Time frame: Change from baseline over 6 months post-randomization
Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient)
Time frame: Change from baseline over 6 months post-randomization
Change in Kingston Caregiver Stress Scale
Time frame: Change from baseline over 6 months post-randomization
Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver)
Time frame: Change from baseline over 6 months post-randomization
Liver Transplant Status
Time frame: 6 months post-randomization
Model for End-Stage Liver Disease (MELD) Score
Time frame: Baseline
Completed Liver Transplants
Time frame: 6 months post-randomization
Physical Symptoms
Time frame: 6 months post-randomization
Presence of Advance Directives
Time frame: 6 months post-randomization
Survival
Time frame: 6 months post-randomization
Provider Satisfaction
Time frame: Change from Baseline to study closeout.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gordon Bernard, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Palliative Care services and Usual hepatic care in people with Liver Diseases and Liver Cirrhosis, run by Vanderbilt University Medical Center 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Nov 2019. 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 22 Nov 2019). 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?
Time to First Hospital Readmission Within 6 Months Post-randomization (time frame: 6 months post-randomization). 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 22 Nov 2019.