Cardiovascular DiseasesTELE-WEARNCT05019157
Cardiac Telerehabilitation Effectiveness Using Wearable Sensors
A study testing Telerehabilitation group and Centre - based rehabilitation group in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by Garyfallia Pepera at 1 site in Greece.
Trial summary
Objective: To evaluate the efficacy, efficiency and cost - effectiveness of a cardiac telerehabilitation program using wearable sensors Design: Supervised single-blinded randomized controlled trial, comparing three groups, with follow-ups at baseline, 12 weeks (completion of the intervention), 6 months after the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Rehabilitation, Telerehabilitation
- What is being tested?
- Telerehabilitation group and Centre - based rehabilitation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2021to Jan 2023
- 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
- adults aged ≥18 years
- stable cardiovascular disease ; acute coronary syndrome; coronary artery bypass grafting within the previous six months
- ability to perform physical exercise,
- to speak, read and write Greek
- possession of a mobile phone/smartphone
- internet access at home
Who cannot join
- ventricular arrhythmia or myocardial ischemia during low to moderate exercise intensity as assessed by symptom limited exercise testing at baseline
- heart failure New York Heart Association (NYHA) class IV
- comorbidity precluding exercise training (e.g. orthopaedic, neurological or cognitive conditions)
- acute myocardial infarction (within two days)
- stenosis
- unstable angina
Show all 13Show fewer
- uncontrolled atrial or ventricular arrhythmia
- aortic uncontrolled congestive heart failure
- acute pulmonary embolism
- acute myocarditis or pericardial effusion
- uncontrolled diabetes mellitus (Type I, II)
- hemodynamic instability or exercise-induced arrhythmia in baseline (initial) assessment
- severe obstructive respiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TELE - WEAR: a Multi - Centre, Blinded, Randomized Controlled Trial Investigating the Efficacy, Efficiency and Cost - Effectiveness of a Cardiac Telerehabilitation Program Using Wearable Sensors (TELE - WEAR). Rationale and Study Design
Objective: To evaluate the efficacy, efficiency and cost - effectiveness of a cardiac telerehabilitation program using wearable sensors
Design: Supervised single-blinded randomized controlled trial, comparing three groups, with follow-ups at baseline, 12 weeks (completion of the intervention), 6 months after the completion of the intervention
Read more
Setting: cardiac rehabilitation centres, patients home environments Participants: A total of 102 cardiac patients, regardless sex, aged 18 years and older were randomly assigned to a telerehabilitation group (n = 34), a centre - based cardiac rehabilitation group(n=34) and a usual care control group (n = 34).
Interventions: Exercise - based cardiac rehabilitation program for the intervention groups (both in cardiac clinics' settings and in patients' homes) consisted of three sessions each week for 12 consecutive weeks. The control group received no exercise intervention.
Measurements: Main outcome was measured by Cardiopulmonary Exercise Testing. Secondary outcomes were measured by accelerometry and the use of proper questionnaires.
Read the detailed description
Methods Research design
A supervised, single - blind, randomized controlled trial design will be used to examine the efficacy, efficiency and cost - effectiveness of a cardiac telerehabilitation program using wearable sensors. The study was approved by the ethics committee of University of Thessaly.
Sample One hundred and two (102) cardiac patients will be recruited from cardiac rehabilitation centres. Subject eligibility criteria are: a) 18 years of age and older b) diagnosis of stable cardiovascular diseases, acute coronary syndrome, coronary artery bypass grafting within the previous six months c) ability to perform physical exercise d) ability to understand and write in the Greek language e) possession of a mobile smartphone and access to internet facilities.
Assessments Study data will be collected at baseline, the completion of the intervention period (12 weeks follow - up) and 6 months after the completion of the intervention (long - term follow - up)
Procedure
The telerehabilitation group will undergo a telemonitored exercise - based rehabilitation program 3 days a week for 12 consecutive weeks for 60'/session. The centre - based rehabilitation group will undertake a supervised exercise - based rehabilitation program 3 days a week for 12 consecutive weeks for 60'/session at the rehabilitation centres' facilities. The control group will not receive any exercise intervention during that period.
Outcome measures Functional ability, as the primary outcome of the study, will be assessed at baseline, at 12 weeks and 6 months after the completion of the intervention (long - term follow - up) via cardiopulmonary exercise testing.
Physical activity will be recorded and evaluated at the 12 weeks follow up andn the long - term follow - up by the use of tri - axial accelerometer and the International Physical Activity Questionnaire (IPAQ).
Quality of life will be assessed at baseline, at 12 weeks and 6 months after the completion of the intervention (long - term follow - up) by the use of Health related quality of life Questionnaire(HRQoL).
Anxiety levels and smoking cessation will be evaluated at baseline, at 12 weeks and 6 months after the completion of the intervention (long - term follow - up) through the use of the Hospital Anxiety and Depression scale (HADS) and the fagerstrom Test for Nicotine Dependence (FTND) respectively.
Training adherence will be evaluated during the 12 week assessment endpoint, taking in account the total number of successfully completed training sessions.
The cost-effectiveness analysis will be performed using the assessment of Quality-adjusted life years (QALYs) as a utility measure, obtained with the EuroQol-5D questionnaire at baseline and 12 - weeks follow - up assessment
- Being tested
- Telerehabilitation group, Centre - based rehabilitation group
- Keywords
- wearable sensors, exercise training, functional capacity
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation groupOther
Participants will undertake the first three training sessions in the outpatient clinic for familiarization with the training modalities, the wearable sensors and the data uploading. Afterwards, the participants will proceed with the telerehabilitation program at their homes. The participants will be lent the wearable sensors and will undergo an exercise - based program 3 times/week, comprising of 10' warm up exercises, 40' aerobic, resistance, balance exercises and 10' cool down.Training sessions will be monitored, in real time, by the study investigator. Participants should upload the recorded data to Polar Flow web platform after every training session and should visit the outpatient clinic every month to upload the accelerometry's recorded data to a secure personal computer) application. Educational and informational videoconferences will be held every week for upright training exercise sessions, physical activity counseling, diet/nutritional and smoking cessation counseling.
Centre - based rehabilitation groupOther
Participants will attend an exercise - based cardiac rehabilitation program at the outpatient clinic's facilities under the supervision of cardiac rehabilitation specialized staff. The participants will receive an individually tailored training program on a treadmill or a cycle ergometer. Total training attendance rate will be documented by the cardiac rehabilitation centre staff. Patients will be instructed to wear a tri - axial accelerometer during the entire 12 weeks study period. Participants should upload recorded data to the local server every month. Educational videoconferences will be held every week for physical activity counseling, diet/nutritional and smoking cessation counseling.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | Participants will undertake the first three training sessions in the outpatient clinic under the supervision of the specialized staff for familiarization with the intervention. and then the participants will proceed with the telerehabilitation program at their homes. Participants will undergo an exercise - based program 3 times/week, comprised of 10' warm up exercises, 40' aerobic, resistance and balance exercises and 10' cool down, with the use of wearable sensors. Receives: Other: Telerehabilitation group |
| Centre - based rehabilitation group | Active comparator | Participants will attend an exercise - based cardiac rehabilitation program at the outpatient clinic's facilities under the supervision of cardiac rehabilitation specialized staff. The participants will receive an individually tailored training program on a treadmill or a cycle ergometer 3 times/week, comprised of 10' warm up exercises, 40' aerobic, resistance and balance exercises and 10' cool down. Receives: Other: Centre - based rehabilitation group |
| Usual care group | No intervention | Patients will not undertake any exercise based intervention and will only follow their usual medication treatment .The patients will wear the accelerometer for the 12 week study duration and visit the corresponding outpatient cardiac clinic every 4 weeks to upload the recorded data. The patients will also receive educational phone videoconference sessions every week for physical activity, diet/nutritional and smoking cessation counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the levels of physical fitness
Physical fitness will be assessed in all study groups by peak oxygen uptake, determined by cardiopulmonary exercise testing (CPET) with respiratory gas analysis at the outpatient clinic.
Measured: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Secondary outcomes (6)
Change in the levels of physical activity
Daily physical activity (PA) is defined as the total number of daily low - intensity and high - intensity steps as measured objectively from a tri-axial accelerometer and subjectively through the use of the International Physical Activity Questionnaire.
Measured: 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Change in the Quality of participants' lives
Assessment of the participants' quality of life will be evaluated with the use of the Health Related Quality of Life questionnaire (HRQoL).
Measured: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Cost - effectiveness
The cost-effectiveness analysis will be performed using the assessment of Quality-adjusted life years (QALYs) as a utility measure. Patients will complete the European Quality of Life Five Dimension (EuroQol-5D) individually and their final scores will be converted into QALYs. The cost / benefit analysis will result from the calculation of the incremental cost-effectiveness ratio (ICER):
ICER = (cost intervention group - cost control group) / (effectiveness intervention group - effectiveness control group).
Incremental cost refers to the difference, per patient, in the total average cost between the intervention groups and the control group. Incremental effectiveness was defined as the difference in the mean change in QALYs between the intervention group and the control group.
Measured: 12 week follow up
Adherence to rehabilitation program
Patients' training adherence is defined as a percentage counted from the total number of completed training sessions. Patients' adherence in the telerehabilitation group will be evaluated through the Polar Flow web application as the overall completion rate of prescribed exercise sessions. Adherence in the centre - based cardiac rehabilitation group is determined as the number of attended training sessions at the outpatient clinic facilities, as recorded by the outpatient clinic's staff.
Measured: 12 week follow up
Change in the levels of anxiety and depression
Anxiety and depression rates will be assessed through the Hospital Anxiety and Depression Scale (HADS) which has seven items for the depression subscale and seven items for the anxiety subscale. Scoring for each item ranges from zero(0) to three(3), with three(3) denoting highest anxiety or depression/anxiety level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Measured: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Change in the smoking behaviour
Smoking cessation will be evaluated through the use of the fagerstrom Test for Nicotine Dependence(FTND).
Measured: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- supervised, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Garyfallia Pepera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Garyfallia Pepera, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019157
- Sponsor's protocol ID
- 364/01-06-2021
- Acronym
- TELE-WEAR
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antoniou V, Xanthopoulos A, Giamouzis G, Davos C, Batalik L, Stavrou V, Gourgoulianis KI, Kapreli E, Skoularigis J, Pepera G. Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol. BMJ Open. 2022 Jun 23;12(6):e059945. doi: 10.1136/bmjopen-2021-059945.
PubMed 35738643
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TELE - WEAR: a Multi - Centre, Blinded, Randomized Controlled Trial Investigating the Efficacy, Efficiency and Cost - Effectiveness of a Cardiac Telerehabilitation Program Using Wearable Sensors (TELE - WEAR). Rationale and Study Design
- ClinicalTrials.gov ID
- NCT05019157
- Acronym / sponsor ID
- TELE-WEAR / 364/01-06-2021
- Keywords
- wearable sensors, exercise training, functional capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Garyfallia PeperaUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 24 Aug 2021 (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.
Objective: To evaluate the efficacy, efficiency and cost - effectiveness of a cardiac telerehabilitation program using wearable sensors
Design: Supervised single-blinded randomized controlled trial, comparing three groups, with follow-ups at baseline, 12 weeks (completion of the intervention), 6 months after the completion of the intervention
Setting: cardiac rehabilitation centres, patients home environments Participants: A total of 102 cardiac patients, regardless sex, aged 18 years and older were randomly assigned to a telerehabilitation group (n = 34), a centre - based cardiac rehabilitation group(n=34) and a usual care control group (n = 34).
Interventions: Exercise - based cardiac rehabilitation program for the intervention groups (both in cardiac clinics' settings and in patients' homes) consisted of three sessions each week for 12 consecutive weeks. The control group received no exercise intervention.
Measurements: Main outcome was measured by Cardiopulmonary Exercise Testing. Secondary outcomes were measured by accelerometry and the use of proper questionnaires.
Detailed description
Methods Research design
A supervised, single - blind, randomized controlled trial design will be used to examine the efficacy, efficiency and cost - effectiveness of a cardiac telerehabilitation program using wearable sensors. The study was approved by the ethics committee of University of Thessaly.
Sample One hundred and two (102) cardiac patients will be recruited from cardiac rehabilitation centres. Subject eligibility criteria are: a) 18 years of age and older b) diagnosis of stable cardiovascular diseases, acute coronary syndrome, coronary artery bypass grafting within the previous six months c) ability to perform physical exercise d) ability to understand and write in the Greek language e) possession of a mobile smartphone and access to internet facilities.
Assessments Study data will be collected at baseline, the completion of the intervention period (12 weeks follow - up) and 6 months after the completion of the intervention (long - term follow - up)
Procedure
The telerehabilitation group will undergo a telemonitored exercise - based rehabilitation program 3 days a week for 12 consecutive weeks for 60'/session. The centre - based rehabilitation group will undertake a supervised exercise - based rehabilitation program 3 days a week for 12 consecutive weeks for 60'/session at the rehabilitation centres' facilities. The control group will not receive any exercise intervention during that period.
Outcome measures Functional ability, as the primary outcome of the study, will be assessed at baseline, at 12 weeks and 6 months after the completion of the intervention (long - term follow - up) via cardiopulmonary exercise testing.
Physical activity will be recorded and evaluated at the 12 weeks follow up andn the long - term follow - up by the use of tri - axial accelerometer and the International Physical Activity Questionnaire (IPAQ).
Quality of life will be assessed at baseline, at 12 weeks and 6 months after the completion of the intervention (long - term follow - up) by the use of Health related quality of life Questionnaire(HRQoL).
Anxiety levels and smoking cessation will be evaluated at baseline, at 12 weeks and 6 months after the completion of the intervention (long - term follow - up) through the use of the Hospital Anxiety and Depression scale (HADS) and the fagerstrom Test for Nicotine Dependence (FTND) respectively.
Training adherence will be evaluated during the 12 week assessment endpoint, taking in account the total number of successfully completed training sessions.
The cost-effectiveness analysis will be performed using the assessment of Quality-adjusted life years (QALYs) as a utility measure, obtained with the EuroQol-5D questionnaire at baseline and 12 - weeks follow - up assessment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- supervised, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Other: Telerehabilitation groupParticipants will undertake the first three training sessions in the outpatient clinic under the supervision of the specialized staff for familiarization with the intervention. and then the participants will proceed with the telerehabilitation program at their homes. Participants will undergo an exercise - based program 3 times/week, comprised of 10' warm up exercises, 40' aerobic, resistance and balance exercises and 10' cool down, with the use of wearable sensors. |
| Centre - based rehabilitation group | Active comparator | Other: Centre - based rehabilitation groupParticipants will attend an exercise - based cardiac rehabilitation program at the outpatient clinic's facilities under the supervision of cardiac rehabilitation specialized staff. The participants will receive an individually tailored training program on a treadmill or a cycle ergometer 3 times/week, comprised of 10' warm up exercises, 40' aerobic, resistance and balance exercises and 10' cool down. |
| Usual care group | No intervention | –Patients will not undertake any exercise based intervention and will only follow their usual medication treatment .The patients will wear the accelerometer for the 12 week study duration and visit the corresponding outpatient cardiac clinic every 4 weeks to upload the recorded data. The patients will also receive educational phone videoconference sessions every week for physical activity, diet/nutritional and smoking cessation counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults aged ≥18 years
- stable cardiovascular disease ; acute coronary syndrome; coronary artery bypass grafting within the previous six months
- ability to perform physical exercise,
- to speak, read and write Greek
- possession of a mobile phone/smartphone
Key exclusion criteria (13 listed)
- ventricular arrhythmia or myocardial ischemia during low to moderate exercise intensity as assessed by symptom limited exercise testing at baseline
- heart failure New York Heart Association (NYHA) class IV
- comorbidity precluding exercise training (e.g. orthopaedic, neurological or cognitive conditions)
- acute myocardial infarction (within two days)
- stenosis
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 |
|---|---|---|
| Telerehabilitation groupParticipants will undertake the first three training sessions in the outpatient clinic for familiarization with the training modalities, the wearable sensors and the data uploading. Afterwards, the participants will proceed with the telerehabilitation program at their homes. The participants will be lent the wearable sensors and will undergo an exercise - based program 3 times/week, comprising of 10' warm up exercises, 40' aerobic, resistance, balance exercises and 10' cool down.Training sessions will be monitored, in real time, by the study investigator. Participants should upload the recorded data to Polar Flow web platform after every training session and should visit the outpatient clinic every month to upload the accelerometry's recorded data to a secure personal computer) application. Educational and informational videoconferences will be held every week for upright training exercise sessions, physical activity counseling, diet/nutritional and smoking cessation counseling. | Other | Telerehabilitation group |
| Centre - based rehabilitation groupParticipants will attend an exercise - based cardiac rehabilitation program at the outpatient clinic's facilities under the supervision of cardiac rehabilitation specialized staff. The participants will receive an individually tailored training program on a treadmill or a cycle ergometer. Total training attendance rate will be documented by the cardiac rehabilitation centre staff. Patients will be instructed to wear a tri - axial accelerometer during the entire 12 weeks study period. Participants should upload recorded data to the local server every month. Educational videoconferences will be held every week for physical activity counseling, diet/nutritional and smoking cessation counseling. | Other | Centre - based rehabilitation group |
Primary outcome
Change in the levels of physical fitness
Time frame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Physical fitness will be assessed in all study groups by peak oxygen uptake, determined by cardiopulmonary exercise testing (CPET) with respiratory gas analysis at the outpatient clinic.
6 secondary outcomes
Change in the levels of physical activity
Time frame: 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Change in the Quality of participants' lives
Time frame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Cost - effectiveness
Time frame: 12 week follow up
Adherence to rehabilitation program
Time frame: 12 week follow up
Change in the levels of anxiety and depression
Time frame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Change in the smoking behaviour
Time frame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 35738643Antoniou V, Xanthopoulos A, Giamouzis G, Davos C, Batalik L, Stavrou V, Gourgoulianis KI, Kapreli E, Skoularigis J, Pepera G. Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol. BMJ Open. 2022 Jun 23;12(6):e059945. doi: 10.1136/bmjopen-2021-059945.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation group and Centre - based rehabilitation group in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by Garyfallia Pepera at 1 site in Greece.
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 6 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. 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 Greece. 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?
Contact VARSAMO ANTONIOU, PhD student (+306944635309, varsamoantoniou@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the levels of physical fitness (time frame: Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention). 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 NCT05019157, which also lists 1 linked publication.
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 24 Aug 2021.