Chronic Obstructive Pulmonary DiseaseNCT03741855
Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of COPD
A study testing Cloud Dx Kit with self-monitoring and Cloud Dx Kit with remote-monitoring in people with Chronic Obstructive Pulmonary Disease, run by Women's College Hospital at 1 site in Canada.
Trial summary
This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Cloud Dx Kit with self-monitoring and Cloud Dx Kit with remote-monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 31 Mar 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD
Who cannot join
- Diagnosis of other significant lung disease (eg. interstitial lung disease) or dementia
- Lack of WiFi at home
- Inability to speak English
- Inability to use this technology due to physical or cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.
It is anticipated that there will be 123 participants enrolled in this study across two experimental arms and one control arm. Participants will be in the study for 6 months and the study will run for 1 year a Markham-Stouffville Hospital. The primary outcome is the participants' self-management and activation which will be measured using The Partners in Health (PIH) scale, a validated scale measuring the current status of self-management, with items on knowledge of the condition and skills to monitor and respond to symptoms.
Read the detailed description
This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.
COPD is a pervasive disease that is estimated to affect 2.6 million Canadians (17%) aged 35 to 79 costing the healthcare system in Canada $1.5 billion annually. Ontarians living with COPD are frequent users of the health care system and account for 24% of hospital admissions and 24% of emergency department (ED) visits. COPD is responsible for the highest percentage (18.8%) of 30-day re-admissions to ED in the province.
A recent Cochrane review and meta-analysis concluded that remote monitoring has shown promise in reducing acute care utilization and reducing the number of exacerbations in COPD patients. While many studies have examined the effects of remote-monitoring, few studies have looked at how self-monitoring without clinical oversight affects patients' self-management skills and quality of life. Our goal is to compare a group of patients that are in both self- and remote-monitoring to a group of patients that are only in a self-monitoring program and compare each relative to a standard care group.
The technology used in this study is the Cloud Dx Connect Health Kit which will be used as a tool for self-monitoring and asynchronous remote-monitoring. It consists of a custom Tablet computer, Pulsewave® wrist cuff monitor, Oximeter, Scale and Therometer. Participants will use the kit to record daily their physiological and symptom readings.
This study will take place at Markham-Stoufville hospital with most patients being recruited from the Outpatient COPD Clinic (Respiratory Health-COPD Clinic) and will include patients who have a clinical diagnosis of COPD that has been diagnosed by their respirologist as per clinical guidelines. Recruitment will be ongoing until 123 patients have been recruited for the intervention phase. Once enrolled, participants will be randomized into one of three arms:
- Self-Management group: Participants in this group will receive the Cloud Dx kit at the start of the study and will continue using it for 6 months. They will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings.
- Remote-Monitoring group: Participants in this group will receive the Cloud Dx kit at the start of the study and will continue using it for 6 months. They will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings. In addition, a respiratory therapist (RT) will be monitoring asynchronously their vitals and contacting them when their vitals exceed pre-determined thresholds. The RT will also check on patients once a week irrespective of the value of the vitals.
- Standard of care group: Participants will not be provided with a technology or an action plan (as the action plan is based on vitals and symptoms).
Primary and secondary outcomes will be assessed through a series of questionnaires at 3 time-points by all participants: at baseline, 3 months and 6 months.In addition, participants will also complete a demographic questionnaire at the initial visit.
Participants who expressed interest in the qualitative component will be invited to complete a qualitative interview. This qualitative process evaluation will occur alongside the quantitative component and will include 5 participants from the remote-monitoring group and 5 participants from the self-monitoring group. Healthcare providers involved in the care of participants will also be approached for participation in this evaluation process as well as upon study completion and will ideally include a sample of up to 5 providers and up to 5 hospital administrators and clinic managers
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Cloud Dx Kit with self-monitoring, Cloud Dx Kit with remote-monitoring
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Self-Management
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cloud Dx Kit with self-monitoringDevice
Patients in this group will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings.
Cloud Dx Kit with remote-monitoringDevice
- Patients in this group will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings.
- A respiratory therapist (RT) will be monitoring asynchronously patient vitals and contacting them when their vitals exceed pre-determined thresholds.
- The RT will also check on patients once a week irrespective of the value of the vitals.
| Study group | Role | What they receive |
|---|---|---|
| Remote-Monitoring Program | Experimental | Cloud Dx kit with remote-monitoring Receives: Device: Cloud Dx Kit with remote-monitoring |
| Self-Monitoring Program | Experimental | Cloud Dx kit with self-monitoring Receives: Device: Cloud Dx Kit with self-monitoring |
| Standard of Care | No intervention | Participants will not be provided with the Cloud DX kit or an action plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-management and Activation
Measured with the Partners in Health Scale (PIHS)
Measured: 6 Months
Secondary outcomes (7)
Quality of Life and Respiratory symptoms
Assessed with the St. George's Respiratory Questionnaire (SGRQ)
Measured: 6 Months
Patient Knowledge of COPD
Measured using the Bristol COPD Knowledge Questionnaire
Measured: 6 Months
COPD Assessment
Measured by the COPD Assessment Test
Measured: 6 Months
Breathlessness
Measured by the MRC Breathlessness Scale
Measured: 6 Months
Total number of contacts/calls to the outpatient clinic and deaths
Recorded by RT; deaths caregiver reported
Measured: 6 Months
Total number of ED presentations, admissions to a hospital, exacerbations, visits to family doctor, number of nurse contacts, self-reported use of medication, self-reported smoking cessation
self-reported
Measured: 6 Months
Total length of stay for all admissions (in days)
self-reported
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Jan 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Markham Stouffville Hospital
- Responsible party
- Sponsor
- Investigators
- Sacha Bhatia, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741855
- Sponsor's protocol ID
- WCHCDX-001
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2018
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be published in an academic peer-reviewed journal.
Publications
Evans J, Chen Y, Camp PG, Bowie DM, McRae L. Estimating the prevalence of COPD in Canada: Reported diagnosis versus measured airflow obstruction. Health Rep. 2014 Mar;25(3):3-11.
PubMed 24648134Gershon AS, Guan J, Victor JC, Goldstein R, To T. Quantifying health services use for chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Mar 15;187(6):596-601. doi: 10.1164/rccm.201211-2044OC. Epub 2013 Jan 17.
PubMed 23328526Government of Canada, S. C. (2017, August 29). CANSIM - 105-0501 - Health indicator profile, annual estimates, by age group and sex, Canada, provinces, territories, health regions (2013 boundaries) and peer groups. Retrieved October 24, 2017, from http://www5.statcan.gc.ca/cansim/a26?lang=eng&id=1050501.
McLean S, Nurmatov U, Liu JL, Pagliari C, Car J, Sheikh A. Telehealthcare for chronic obstructive pulmonary disease: Cochrane Review and meta-analysis. Br J Gen Pract. 2012 Nov;62(604):e739-49. doi: 10.3399/bjgp12X658269.
PubMed 23211177Mittmann N, Kuramoto L, Seung SJ, Haddon JM, Bradley-Kennedy C, Fitzgerald JM. The cost of moderate and severe COPD exacerbations to the Canadian healthcare system. Respir Med. 2008 Mar;102(3):413-21. doi: 10.1016/j.rmed.2007.10.010. Epub 2007 Dec 20.
PubMed 18086519Stamenova V, Liang K, Yang R, Engel K, van Lieshout F, Lalingo E, Cheung A, Erwood A, Radina M, Greenwald A, Agarwal P, Sidhu A, Bhatia RS, Shaw J, Shafai R, Bhattacharyya O. Technology-Enabled Self-Management of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Randomized Controlled Trial. J Med Internet Res. 2020 Jul 30;22(7):e18598. doi: 10.2196/18598.
PubMed 32729843Stamenova V, Yang R, Engel K, Liang K, van Lieshout F, Lalingo E, Cheung A, Erwood A, Radina M, Greenwald A, Agarwal P, Sidhu A, Bhatia RS, Shaw J, Shafai R, Bhattacharyya O. Technology-Enabled Self-Monitoring of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Aug 19;8(8):e13920. doi: 10.2196/13920.
PubMed 31429418
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Cloud DX Platform as a Tool for Self-management and Asynchronous Remote-monitoring of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03741855
- Acronym / sponsor ID
- WCHCDX-001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Markham Stouffville Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 15 Nov 2018 (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.
This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.
It is anticipated that there will be 123 participants enrolled in this study across two experimental arms and one control arm. Participants will be in the study for 6 months and the study will run for 1 year a Markham-Stouffville Hospital. The primary outcome is the participants' self-management and activation which will be measured using The Partners in Health (PIH) scale, a validated scale measuring the current status of self-management, with items on knowledge of the condition and skills to monitor and respond to symptoms.
Detailed description
This study is an open-label, prospective, single-centre, randomized controlled trial, containing both a quantitative and a qualitative component and using a mixed-methods design. The study evaluates the impact of Cloud Dx kit, a device that can allows patients to monitor and manage Chronic Obstructive Pulmonary Disease (COPD) at their home. The study evaluates whether using Cloud Dx improves patients' COPD symptoms, ability to manage COPD, and quality of life.
COPD is a pervasive disease that is estimated to affect 2.6 million Canadians (17%) aged 35 to 79 costing the healthcare system in Canada $1.5 billion annually. Ontarians living with COPD are frequent users of the health care system and account for 24% of hospital admissions and 24% of emergency department (ED) visits. COPD is responsible for the highest percentage (18.8%) of 30-day re-admissions to ED in the province.
A recent Cochrane review and meta-analysis concluded that remote monitoring has shown promise in reducing acute care utilization and reducing the number of exacerbations in COPD patients. While many studies have examined the effects of remote-monitoring, few studies have looked at how self-monitoring without clinical oversight affects patients' self-management skills and quality of life. Our goal is to compare a group of patients that are in both self- and remote-monitoring to a group of patients that are only in a self-monitoring program and compare each relative to a standard care group.
The technology used in this study is the Cloud Dx Connect Health Kit which will be used as a tool for self-monitoring and asynchronous remote-monitoring. It consists of a custom Tablet computer, Pulsewave® wrist cuff monitor, Oximeter, Scale and Therometer. Participants will use the kit to record daily their physiological and symptom readings.
This study will take place at Markham-Stoufville hospital with most patients being recruited from the Outpatient COPD Clinic (Respiratory Health-COPD Clinic) and will include patients who have a clinical diagnosis of COPD that has been diagnosed by their respirologist as per clinical guidelines. Recruitment will be ongoing until 123 patients have been recruited for the intervention phase. Once enrolled, participants will be randomized into one of three arms:
- Self-Management group: Participants in this group will receive the Cloud Dx kit at the start of the study and will continue using it for 6 months. They will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings.
- Remote-Monitoring group: Participants in this group will receive the Cloud Dx kit at the start of the study and will continue using it for 6 months. They will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings. In addition, a respiratory therapist (RT) will be monitoring asynchronously their vitals and contacting them when their vitals exceed pre-determined thresholds. The RT will also check on patients once a week irrespective of the value of the vitals.
- Standard of care group: Participants will not be provided with a technology or an action plan (as the action plan is based on vitals and symptoms).
Primary and secondary outcomes will be assessed through a series of questionnaires at 3 time-points by all participants: at baseline, 3 months and 6 months.In addition, participants will also complete a demographic questionnaire at the initial visit.
Participants who expressed interest in the qualitative component will be invited to complete a qualitative interview. This qualitative process evaluation will occur alongside the quantitative component and will include 5 participants from the remote-monitoring group and 5 participants from the self-monitoring group. Healthcare providers involved in the care of participants will also be approached for participation in this evaluation process as well as upon study completion and will ideally include a sample of up to 5 providers and up to 5 hospital administrators and clinic managers
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote-Monitoring Program | Experimental | Device: Cloud Dx Kit with remote-monitoringCloud Dx kit with remote-monitoring |
| Self-Monitoring Program | Experimental | Device: Cloud Dx Kit with self-monitoringCloud Dx kit with self-monitoring |
| Standard of Care | No intervention | –Participants will not be provided with the Cloud DX kit or an action plan |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of COPD
Key exclusion criteria (4 listed)
- Diagnosis of other significant lung disease (eg. interstitial lung disease) or dementia
- Lack of WiFi at home
- Inability to speak English
- Inability to use this technology due to physical or cognitive impairment
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 |
|---|---|---|
| Cloud Dx Kit with self-monitoringPatients in this group will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings. | Device | Self-Monitoring Program |
| Cloud Dx Kit with remote-monitoring* Patients in this group will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings. * A respiratory therapist (RT) will be monitoring asynchronously patient vitals and contacting them when their vitals exceed pre-determined thresholds. * The RT will also check on patients once a week irrespective of the value of the vitals. | Device | Remote-Monitoring Program |
Primary outcome
Self-management and Activation
Time frame: 6 Months
Measured with the Partners in Health Scale (PIHS)
7 secondary outcomes
Quality of Life and Respiratory symptoms
Time frame: 6 Months
Patient Knowledge of COPD
Time frame: 6 Months
COPD Assessment
Time frame: 6 Months
Breathlessness
Time frame: 6 Months
Total number of contacts/calls to the outpatient clinic and deaths
Time frame: 6 Months
Total number of ED presentations, admissions to a hospital, exacerbations, visits to family doctor, number of nurse contacts, self-reported use of medication, self-reported smoking cessation
Time frame: 6 Months
Total length of stay for all admissions (in days)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Background: PubMed 24648134Evans J, Chen Y, Camp PG, Bowie DM, McRae L. Estimating the prevalence of COPD in Canada: Reported diagnosis versus measured airflow obstruction. Health Rep. 2014 Mar;25(3):3-11.
- Background: PubMed 23328526Gershon AS, Guan J, Victor JC, Goldstein R, To T. Quantifying health services use for chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Mar 15;187(6):596-601. doi: 10.1164/rccm.201211-2044OC. Epub 2013 Jan 17.
- BackgroundGovernment of Canada, S. C. (2017, August 29). CANSIM - 105-0501 - Health indicator profile, annual estimates, by age group and sex, Canada, provinces, territories, health regions (2013 boundaries) and peer groups. Retrieved October 24, 2017, from http://www5.statcan.gc.ca/cansim/a26?lang=eng&id=1050501.
- Background: PubMed 23211177McLean S, Nurmatov U, Liu JL, Pagliari C, Car J, Sheikh A. Telehealthcare for chronic obstructive pulmonary disease: Cochrane Review and meta-analysis. Br J Gen Pract. 2012 Nov;62(604):e739-49. doi: 10.3399/bjgp12X658269.
- Background: PubMed 18086519Mittmann N, Kuramoto L, Seung SJ, Haddon JM, Bradley-Kennedy C, Fitzgerald JM. The cost of moderate and severe COPD exacerbations to the Canadian healthcare system. Respir Med. 2008 Mar;102(3):413-21. doi: 10.1016/j.rmed.2007.10.010. Epub 2007 Dec 20.
- Derived from this study: PubMed 32729843Stamenova V, Liang K, Yang R, Engel K, van Lieshout F, Lalingo E, Cheung A, Erwood A, Radina M, Greenwald A, Agarwal P, Sidhu A, Bhatia RS, Shaw J, Shafai R, Bhattacharyya O. Technology-Enabled Self-Management of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Randomized Controlled Trial. J Med Internet Res. 2020 Jul 30;22(7):e18598. doi: 10.2196/18598.
- Derived from this study: PubMed 31429418Stamenova V, Yang R, Engel K, Liang K, van Lieshout F, Lalingo E, Cheung A, Erwood A, Radina M, Greenwald A, Agarwal P, Sidhu A, Bhatia RS, Shaw J, Shafai R, Bhattacharyya O. Technology-Enabled Self-Monitoring of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Aug 19;8(8):e13920. doi: 10.2196/13920.
- Individual participant dataSharing planned: Yes. Results will be published in an academic peer-reviewed journal.
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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.
Sacha Bhatia principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cloud Dx Kit with self-monitoring and Cloud Dx Kit with remote-monitoring in people with Chronic Obstructive Pulmonary Disease, run by Women's College Hospital at 1 site in Canada.
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 4 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 29 Oct 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-management and Activation (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741855, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.