Noninvasive VentilationNCT03932175
Behavioural Intervention in Mechanically Ventilated Patients
A study testing Intervention group in people with Noninvasive Ventilation and Chronic Disease Lung, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Background: Non-invasive ventilation at home for chronic respiratory failure due to different etiologies has proven effective regarding mortality and quality of life. Nonetheless, adherence to therapy still constitutes a clinical day-to-day problem. Physiological monitoring has shown to improve adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventilation, Chronic Disease Lung
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 25 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients with hypercapnic ventilatory failure due to chest wall, neuromuscular, lung parenchyma and/ or airway disease already receiving treatment with non-invasive ventilation irrespective of treatment duration.
- Having a mobile phone, tablet or personal computer that can support the use of MyPathway application.
- Accepting to participate in the study and signing informed consent.
Who cannot join
- Clinical instability (including a respiratory acute exacerbation) at time of assessment for study enrolment.
- Not willing to use the proposed mHealth tool at home.
- Severe psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Behavioural Intervention in Home-based Mechanically Ventilated Patients
Background: Non-invasive ventilation at home for chronic respiratory failure due to different etiologies has proven effective regarding mortality and quality of life. Nonetheless, adherence to therapy still constitutes a clinical day-to-day problem. Physiological monitoring has shown to improve adherence. We hypothesise that an additional behavioural intervention delivered via mHealth tools, on top of usual care, can further enhance therapeutical success alongside patient satisfaction.
Methods: Randomized single-blinded controlled trial with an intervention and control groups. Intervention will consist of a multi-component based behavioural intervention delivered via a mHealth tool, during a three-month period. Primary objective will be change in self-efficacy towards non-invasive ventilation use
Read more
Statistical Analysis: Based on a change of 0.5 units in the Self Efficacy in Sleep apnea (SEMSA) questionnaire, a sample size of 30 subjects per study arm was calculated. It has been anticipated a drop-out rate of 5%. Standard statistical analysis will take place.
Expected results: we expect a positive change on the SEMSA score (reflecting better self-efficacy) after three-month use. Indirectly, this enhancement should facilitate patient adherence specifically via mask leak problems resolution. Also, we presume that the proposed mHealth tool will be highly usable and accepted by the patients, leading to overall satisfaction with the service provided.
Read the detailed description
The polio epidemics demonstrated the safety and efficacy of non-invasive ventilation (NIV) to decrease mortality. Since then, this therapeutic approach has been shown to reduce hospital admissions, impact favourably on health-related quality of life (HRQL), improve sleep quality and reduce mortality in patients with diverse chronic pathologies. This success has driven the increase in prevalence of patients using home NIV in Europe, ranging from 4.5 to 20 per 100,000 adults.
The use of NIV at home has been proven to be cost-effective, but patients' adherence to therapy has still potential to improve which should further enhance healthcare efficiencies of the intervention. Optimization of physiological settings and monitoring can contribute to enhance adherence by improving timely detection of problems such as mask leaks, patient-ventilator asynchronies, etc. However, improvement of behavioural aspects such as patient motivation and empowerment for self-management are also important factors to consider when addressing adherence to respiratory therapies.
The current protocol seeks to explore the transfer of previous positive experiences on behavioural interventions in other fields (i.e. physical activity into home-based NIV and, in general, into respiratory therapies. Specifically, we will explore the concept of self-efficacy. It is defined as the individual's perceived capability to perform the particular behaviour. A person who does not believe in her or his own capability to perform a desired action will fail to adopt, initiate, and maintain it. Self-efficacy is therefore seen as the most influential motivational factor and the strongest predictor of behavioural intentions.
The application of self-efficacy to the problem of identifying predictors of BIPAP use derives from the social cognitive theory concept of Bandura (Bandura's model). This model has been widely applied in studies of the adoption, initiation, and maintenance of health-promoting behaviors and consists of the concepts of perception of the risk to health, expectations regarding treatment outcome (outcome expectancies), and the confidence or volition to engage in the behavior (treatment self-efficacy).
Alongside this well-defined behavioural concept, we also identify the role of information and communication technologies (ICT) as a promising scenario to generate efficiencies by enhancing coordination between stakeholders and contributing to improve health outcomes.
Nonetheless, it is acknowledged that the scenario is not still mature. Mainly, because of lacking evidence in real-world scenarios for the capacity of ICT to escort behavioural changes in chronic complex patients. It is widely accepted that, despite current limitations, chronic complex patients are an ideal population where care coordination, patient and medical staff satisfaction alongside patient empowerment are of utmost importance to produce health benefits.
The study protocol intends to produce evidence on the capacity of a behavioural intervention to increase patient empowerment for self-management and adherence to therapy accompanied by an ICT tool interoperable with the information system of the healthcare provider. Moreover, the intervention should generate high acceptability/satisfaction among patients, carers and professionals. We fully acknowledge that if the expected results are achieved, the proposed study shall be followed by long-term assessment of the impact of the intervention.
- Conditions
- Noninvasive Ventilation, Chronic Disease Lung
- Being tested
- Intervention group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Behaviorial intervention on non-invasive ventilation use and adherence alongside lifestyle changes recommendations supported by an mHealth tool (MyPathway app)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The multicomponent intervention will comprise three aspects on-top of usual care: i) Motivational interview to assess patient's adherence profile and to raise the compromise with the behaviour change towards NIV, physical activity and nutritional habits; ii) Bi-directional interaction between the study participants and clinical staff delivered by the MyPathway app, where specific clinical problems regarding NIV will be addressed as they arise; and iii) Motivational messages and educational material delivered via the MyPathway app regarding changes in physical activity and/or nutritional habits. As part of the behavioural intervention, goal setting for NIV adherence and life-style changes will be introduced to the MyPathway app in order for the participants to follow the advice. Receives: Behavioral: Intervention group |
| Control group | No intervention | Patients will receive usual care according to guidelines on management of chronically ventilated patients, without any mHealth tool or behavioural intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self efficacy
Change in the Self Efficacy in Sleep apnea (SEMSA) questionnaire
Measured: 3 months
Secondary outcomes (7)
mHealth tool usability
mHealth tool usability assessed by the System Usability Scale
Measured: 3 months
Patient satisfaction
Patient satisfaction with the mHealth tool assessed by the Net Promoter Score
Measured: 3 months
Non-invasive ventilation adherence
Number of hours of daily use of the non-invasive ventilation machine during the study period
Measured: 3 months
Patient centred healthcare provision
Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire
Measured: 3 months
Continuity of care within the healthcare system
Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
Measured: 3 months
Health and well-being
Change in quality of life assessed by the EuroQol-5D questionnaire
Measured: 3 months
Sleepiness
Change in sleepiness assessed by the Epworth Sleepiness Score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Feb 2019
- Primary completion19 Jun 2019 (estimated)
- Study completion25 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-groups, randomised parallel study with 1:1 ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CRISTINA EMBID LOPEZ, Hospital Clinic of Barcelona
- Investigators
- Cristina Embid, MD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932175
- Sponsor's protocol ID
- NIV - MyPathway
- Status last verified
- Apr 2019
- First submitted
- 26 Apr 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lloyd-Owen SJ, Donaldson GC, Ambrosino N, Escarabill J, Farre R, Fauroux B, Robert D, Schoenhofer B, Simonds AK, Wedzicha JA. Patterns of home mechanical ventilation use in Europe: results from the Eurovent survey. Eur Respir J. 2005 Jun;25(6):1025-31. doi: 10.1183/09031936.05.00066704.
PubMed 15929957de Lucas Ramos P, Rodriguez Gonzalez-Moro JM, Paz Gonzalez L, Santa-Cruz Siminiani A, Cubillo Marcos JM. [Current status of home mechanical ventilation in Spain: results of a national survey]. Arch Bronconeumol. 2000 Nov;36(10):545-50. Spanish.
PubMed 11149196Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
PubMed 28489682Troosters T, Maltais F, Leidy N, Lavoie KL, Sedeno M, Janssens W, Garcia-Aymerich J, Erzen D, De Sousa D, Korducki L, Hamilton A, Bourbeau J. Effect of Bronchodilation, Exercise Training, and Behavior Modification on Symptoms and Physical Activity in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Oct 15;198(8):1021-1032. doi: 10.1164/rccm.201706-1288OC.
PubMed 29664681Bandura A. Self-efficacy mechanism in human agency. Am Psychol. 1982;37(2):122-47.
Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
PubMed 847061Ambrosino N, Vitacca M, Dreher M, Isetta V, Montserrat JM, Tonia T, Turchetti G, Winck JC, Burgos F, Kampelmacher M, Vagheggini G; ERS Tele-Monitoring of Ventilator-Dependent Patients Task Force. Tele-monitoring of ventilator-dependent patients: a European Respiratory Society Statement. Eur Respir J. 2016 Sep;48(3):648-63. doi: 10.1183/13993003.01721-2015. Epub 2016 Jul 7.
PubMed 27390283Baltaxe E, Embid C, Aumatell E, Martinez M, Barberan-Garcia A, Kelly J, Eaglesham J, Herranz C, Vargiu E, Montserrat JM, Roca J, Cano I. Integrated Care Intervention Supported by a Mobile Health Tool for Patients Using Noninvasive Ventilation at Home: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 13;8(4):e16395. doi: 10.2196/16395.
PubMed 32281941
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Behavioural Intervention in Home-based Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT03932175
- Acronym / sponsor ID
- NIV - MyPathway
- Conditions
- Noninvasive Ventilation, Chronic Disease Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 19 Jun 2019 (estimated)
- Study completion
- 25 Jun 2019 (estimated)
- First posted
- 30 Apr 2019 (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.
Background: Non-invasive ventilation at home for chronic respiratory failure due to different etiologies has proven effective regarding mortality and quality of life. Nonetheless, adherence to therapy still constitutes a clinical day-to-day problem. Physiological monitoring has shown to improve adherence. We hypothesise that an additional behavioural intervention delivered via mHealth tools, on top of usual care, can further enhance therapeutical success alongside patient satisfaction.
Methods: Randomized single-blinded controlled trial with an intervention and control groups. Intervention will consist of a multi-component based behavioural intervention delivered via a mHealth tool, during a three-month period. Primary objective will be change in self-efficacy towards non-invasive ventilation use
Statistical Analysis: Based on a change of 0.5 units in the Self Efficacy in Sleep apnea (SEMSA) questionnaire, a sample size of 30 subjects per study arm was calculated. It has been anticipated a drop-out rate of 5%. Standard statistical analysis will take place.
Expected results: we expect a positive change on the SEMSA score (reflecting better self-efficacy) after three-month use. Indirectly, this enhancement should facilitate patient adherence specifically via mask leak problems resolution. Also, we presume that the proposed mHealth tool will be highly usable and accepted by the patients, leading to overall satisfaction with the service provided.
Detailed description
The polio epidemics demonstrated the safety and efficacy of non-invasive ventilation (NIV) to decrease mortality. Since then, this therapeutic approach has been shown to reduce hospital admissions, impact favourably on health-related quality of life (HRQL), improve sleep quality and reduce mortality in patients with diverse chronic pathologies. This success has driven the increase in prevalence of patients using home NIV in Europe, ranging from 4.5 to 20 per 100,000 adults.
The use of NIV at home has been proven to be cost-effective, but patients' adherence to therapy has still potential to improve which should further enhance healthcare efficiencies of the intervention. Optimization of physiological settings and monitoring can contribute to enhance adherence by improving timely detection of problems such as mask leaks, patient-ventilator asynchronies, etc. However, improvement of behavioural aspects such as patient motivation and empowerment for self-management are also important factors to consider when addressing adherence to respiratory therapies.
The current protocol seeks to explore the transfer of previous positive experiences on behavioural interventions in other fields (i.e. physical activity into home-based NIV and, in general, into respiratory therapies. Specifically, we will explore the concept of self-efficacy. It is defined as the individual's perceived capability to perform the particular behaviour. A person who does not believe in her or his own capability to perform a desired action will fail to adopt, initiate, and maintain it. Self-efficacy is therefore seen as the most influential motivational factor and the strongest predictor of behavioural intentions.
The application of self-efficacy to the problem of identifying predictors of BIPAP use derives from the social cognitive theory concept of Bandura (Bandura's model). This model has been widely applied in studies of the adoption, initiation, and maintenance of health-promoting behaviors and consists of the concepts of perception of the risk to health, expectations regarding treatment outcome (outcome expectancies), and the confidence or volition to engage in the behavior (treatment self-efficacy).
Alongside this well-defined behavioural concept, we also identify the role of information and communication technologies (ICT) as a promising scenario to generate efficiencies by enhancing coordination between stakeholders and contributing to improve health outcomes.
Nonetheless, it is acknowledged that the scenario is not still mature. Mainly, because of lacking evidence in real-world scenarios for the capacity of ICT to escort behavioural changes in chronic complex patients. It is widely accepted that, despite current limitations, chronic complex patients are an ideal population where care coordination, patient and medical staff satisfaction alongside patient empowerment are of utmost importance to produce health benefits.
The study protocol intends to produce evidence on the capacity of a behavioural intervention to increase patient empowerment for self-management and adherence to therapy accompanied by an ICT tool interoperable with the information system of the healthcare provider. Moreover, the intervention should generate high acceptability/satisfaction among patients, carers and professionals. We fully acknowledge that if the expected results are achieved, the proposed study shall be followed by long-term assessment of the impact of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-groups, randomised parallel study with 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupThe multicomponent intervention will comprise three aspects on-top of usual care: i) Motivational interview to assess patient's adherence profile and to raise the compromise with the behaviour change towards NIV, physical activity and nutritional habits; ii) Bi-directional interaction between the study participants and clinical staff delivered by the MyPathway app, where specific clinical problems regarding NIV will be addressed as they arise; and iii) Motivational messages and educational material delivered via the MyPathway app regarding changes in physical activity and/or nutritional habits. As part of the behavioural intervention, goal setting for NIV adherence and life-style changes will be introduced to the MyPathway app in order for the participants to follow the advice. |
| Control group | No intervention | –Patients will receive usual care according to guidelines on management of chronically ventilated patients, without any mHealth tool or behavioural intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adult patients with hypercapnic ventilatory failure due to chest wall, neuromuscular, lung parenchyma and/ or airway disease already receiving treatment with non-invasive ventilation irrespective of treatment duration.
- Having a mobile phone, tablet or personal computer that can support the use of MyPathway application.
- Accepting to participate in the study and signing informed consent.
Key exclusion criteria (3 listed)
- Clinical instability (including a respiratory acute exacerbation) at time of assessment for study enrolment.
- Not willing to use the proposed mHealth tool at home.
- Severe psychiatric disease.
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 |
|---|---|---|
| Intervention groupBehaviorial intervention on non-invasive ventilation use and adherence alongside lifestyle changes recommendations supported by an mHealth tool (MyPathway app) | Behavioural | Intervention group |
Primary outcome
Self efficacy
Time frame: 3 months
Change in the Self Efficacy in Sleep apnea (SEMSA) questionnaire
7 secondary outcomes
mHealth tool usability
Time frame: 3 months
Patient satisfaction
Time frame: 3 months
Non-invasive ventilation adherence
Time frame: 3 months
Patient centred healthcare provision
Time frame: 3 months
Continuity of care within the healthcare system
Time frame: 3 months
Health and well-being
Time frame: 3 months
Sleepiness
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Background: PubMed 15929957Lloyd-Owen SJ, Donaldson GC, Ambrosino N, Escarabill J, Farre R, Fauroux B, Robert D, Schoenhofer B, Simonds AK, Wedzicha JA. Patterns of home mechanical ventilation use in Europe: results from the Eurovent survey. Eur Respir J. 2005 Jun;25(6):1025-31. doi: 10.1183/09031936.05.00066704.
- Background: PubMed 11149196de Lucas Ramos P, Rodriguez Gonzalez-Moro JM, Paz Gonzalez L, Santa-Cruz Siminiani A, Cubillo Marcos JM. [Current status of home mechanical ventilation in Spain: results of a national survey]. Arch Bronconeumol. 2000 Nov;36(10):545-50. Spanish.
- Background: PubMed 28489682Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
- Background: PubMed 29664681Troosters T, Maltais F, Leidy N, Lavoie KL, Sedeno M, Janssens W, Garcia-Aymerich J, Erzen D, De Sousa D, Korducki L, Hamilton A, Bourbeau J. Effect of Bronchodilation, Exercise Training, and Behavior Modification on Symptoms and Physical Activity in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Oct 15;198(8):1021-1032. doi: 10.1164/rccm.201706-1288OC.
- BackgroundBandura A. Self-efficacy mechanism in human agency. Am Psychol. 1982;37(2):122-47.
- Background: PubMed 847061Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
- Background: PubMed 27390283Ambrosino N, Vitacca M, Dreher M, Isetta V, Montserrat JM, Tonia T, Turchetti G, Winck JC, Burgos F, Kampelmacher M, Vagheggini G; ERS Tele-Monitoring of Ventilator-Dependent Patients Task Force. Tele-monitoring of ventilator-dependent patients: a European Respiratory Society Statement. Eur Respir J. 2016 Sep;48(3):648-63. doi: 10.1183/13993003.01721-2015. Epub 2016 Jul 7.
- Derived from this study: PubMed 32281941Baltaxe E, Embid C, Aumatell E, Martinez M, Barberan-Garcia A, Kelly J, Eaglesham J, Herranz C, Vargiu E, Montserrat JM, Roca J, Cano I. Integrated Care Intervention Supported by a Mobile Health Tool for Patients Using Noninvasive Ventilation at Home: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 13;8(4):e16395. doi: 10.2196/16395.
- 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.
Cristina Embid, MD principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Noninvasive Ventilation and Chronic Disease Lung, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Apr 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 Spain. 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?
Results are not available in the source record.
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 efficacy (time frame: 3 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 NCT03932175, which also lists 8 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 30 Apr 2019; AzTrials last refreshed its copy on 1 Nov 2026.