ADHDNCT05270226
Metacognitive ADHD Telehealth Intervention for Work-performance Enhancement (Work-MATE)
A study testing The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) in people with ADHD, run by Sara Rosenblum at 1 site in Israel.
Trial summary
Adults with Attention-deficit hyperactivity disorder (ADHD) experience poor occupational performance at work compare to adults without ADHD, manifested at tendencies toward unemployment, job instability, work accidents, and sickness absences. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- ADHD
- What is being tested?
- The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2018to 21 Feb 2020
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants worked at least 3 months at the same workplace.
- Participants had formal medical diagnosis of ADHD.
- Symptoms consistent with ADHD were confirmed either by the Adult ADHD Self-Report Scale (ASRS) version 1.1 (Kessler et al., 2005) final score or by medium-to-high probability of ADHD according to the BADDS (Brown, 2012).
- Participants had at least one EF deficit according to the BRIEF-A (Roth et al., 2005).
- Participants not receiving any functional additional treatment during the study period.
- Participants read and write Hebrew fluently.
Who cannot join
- People who self-reported comorbid mental health disorders, motor or neurological disabilities, chronic diseases, or significant injuries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Evaluating a Metacognitive ADHD Telehealth Intervention for Work-performance Enhancement (Work-MATE) Amongst Adults With ADHD
Adults with Attention-deficit hyperactivity disorder (ADHD) experience poor occupational performance at work compare to adults without ADHD, manifested at tendencies toward unemployment, job instability, work accidents, and sickness absences. This poor occupational performance at work may be partly caused by difficulties at executive functions (EF) abilities, and at the ability to set and attain goal directed work-activities at a satisfactory manner. Therefore, improvement at those abilities may followed by occupational performance at work enhancement of adults with ADHD. Such improvement may enhance adults with ADHD quality of life.
Despite the wide-ranging implications of poor occupational performance at work of adults with ADHD, treatments which focus at this component improvement among adults with ADHD are lack.
Read more
The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) is an innovative program that aim to improve occupational performance at work of adults with ADHD, by enhancing their EF abilities, self-awareness, and personal strategy use.
This program was established based on existing fundamental models and approach, (1) The World Health Organization's international classification of functioning, disability and health (ICF) (WHO, 2001), (2) Person-Environment-Occupation-Performance model (Baum, Christiansen, \& Bass-Haugen, 2015) (3) The Dynamic Interactional Model of cognition (DIM; Toglia, 2018) and the Multicontex approach (Toglia, 2018) which based on the it, and (4) Telehealth as service-delivering model.
The Work-MATE aim to promote self-awareness and self-generation of personal strategies and increase efficiency strategy use across meaningful purposeful everyday work activities (i.e., goal directed work-activities). It is a short, synchronous and hybrid teleintervention program of eleven 1-hour weekly individual sessions, focused directly on occupational performance at work enhancement of adults with ADHD.
Read the detailed description
Research Aim:
To develop and evaluate effectiveness of Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE), of adults with ADHD.
Hypotheses:
The study sample (n=46) includes adults with ADHD, after confirmation of inclusion and exclusion criteria and symptoms consistency of ADHD. Participants enrolled randomly into two groups:
- Group A (n=31)- received treatment immediately after the first assessment.
- Group B (n =16)- was reassessed 10-11 weeks after the first assessment (the length of the treatment process), and then received treatment.
Both groups were reassessed at the end of the treatment (second assessment for group A and third assessment for group B). An additional assessment was performed three months after the end of treatment.
The hypotheses are presented in three stages:
Stage 1:
- A comparison of the characteristics of study groups (A and B) participants as a preliminary stage to their unification as one group (n=46). Hypothesis 1: Differences will not be found in the demographic and occupational characteristics of participants when assessed using demographic and occupational questionnaires, and the ADHD characteristics using the Brown Attention-Deficit Disorder Scales (BADDS).
- To examine the change in group B (n = 16) prior to treatment.
Hypothesis 2: Differences will not be found between assessment 1 and assessment 2 before the treatment in the following variables:
- a. EF abilities- measured by Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) 2. b. occupational performance at work- evaluated by performance and satisfaction with performance scores as measured with the Canadian Occupational Performance Measure (COPM).
- c. Quality of life- evaluated by Adult ADHD Quality of Life Questionnaire (AAQoL).
- d. Organization in time ability- evaluated by Time Organization and Participation Scale (TOPS).
- e. ADHD characteristics- evaluated by BADDS questionnaire.
Stage 2: Effectiveness of the Treatment
- Examination of the effectiveness of the treatment process within both study groups (A and B) (n = 46), before and after treatment, and three months after its completion.
Hypothesis 3: Differences will be found in both study groups (research and comparison) before and after treatment, and after a follow-up assessment three months later, regarding:
- a. EF abilities- measured by BRIEF-A. 3. b. occupational performance at work- evaluated by performance and satisfaction with performance scores as measured with the COPM.
- c. Quality of life- evaluated by AAQoL. 3. d. Organization in time ability- evaluated by TOPS. 3. e. ADHD characteristics- evaluated by BADDS questionnaire.
- Conditions
- ADHD
- Being tested
- The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE)
- Keywords
- Work Performance, Occupational Performance, Executive Functions, Quality of Life, Organization in Time
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE)Behavioural
The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) is an innovative program that aim to improve occupational performance at work of adults with ADHD, by enhancing their EF abilities, self-awareness, and personal strategy use.
The Work-MATE is a short, synchronous and hybrid teleintervention program of eleven 1-hour weekly individual sessions. It offers a written standardized protocol, which include uniform structure of each intervention session and pool of therapy aids (for self-tailored matching by occupational therapists).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | After being randomly allocated, group A participants had first evaluation (out of 3, pre-intervention) and immidiatlly recived Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE). Receives: Behavioral: The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) |
| Group B | Experimental | After being randomly allocated, group B participants had first evaluation (out of 4), then waiting-phase of 10-11 weeks, and after second evaluation (pre-intervention) start Work-MATE intervention process. Receives: Behavioral: The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Canadian Occupational Performance Measure (COPM) at 3 and 6 months
COPM used to evaluate self-perception of occupational performance at work. During semi-structured interview at the third session of intervention, the participant was asked to identify two meaningful activities for which he perceived the greatest performance problems during work, or activities that influence his occupational performance at work. Those two activities were set up as the two intervention goals. Participants rated each activity for performance from 1 (not able to do at all) to 10 (able to do extremely well) and similarly for satisfaction with performance. Significant improvement was considered as a change of at least two points between measures.
Measured: Measure 1 (baseline; at third intervention meeting), measure 2 (after intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
Change from Baseline Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) at 3 and 6 months
BRIEF-A measure EF abilities following the intervention. The score includes a global executive composite (GEC) index that represents the overall EF score, composed of a behavioral regulation index (BRI) score and a metacognition index (MI) score with nine nonoverlapping score scales. Scores of 65 or more for each index or scale indicate a clinical deficit.
Measured: Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
Secondary outcomes (3)
Change from Baseline Adult ADHD Quality of Life Questionnaire (AAQoL) at 3 and 6 months
AAQOL measures QoL of adults with ADHD, focusing on four domains: life productivity, psychological health, relationships, and life outlook. The AAQoL consists of 29 items rated on a 5-point scale for frequency of occurrence, which yields a total score and four subscale scores (reflecting the four domains). higher scores indicating better QoL.
Measured: Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
Change from Baseline Time Organization and Participation Scale (TOPS) at 3 and 6 months
TOPS assesses the perceived ability of the individual to organize daily life tasks on time. Using this questionnaire three domains of organization on time had been evaluated: A, daily task performance at an appropriate pace; B, the individual's success in organizing a whole day or a certain period in a satisfactory manner; C, the frequency of emotional responses following disorganization in time. Because domain D items are used for clinical purposes, they not statistically analyzed in this study. In all domains, lower scores indicate higher risk of difficulties in organization and participation in time in daily tasks. Participants who had a mean final score less than 3.16 were considered to be at risk for difficulties in on-time organization of daily life tasks.
Measured: Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
Change from Baseline Brown Attention-Deficit Disorder Scales (BADDS) at 3 and 6 months
BADDS measures a range of ADHD symptoms. The items are grouped into five clusters: organizing and activating to work, ssustaining attention and concentration, sustaining energy and effort, Managing Affective Interference, and utilizing working memory and accessing Recall. Clusters T scores greater than 65 is considered clinically significant
Measured: Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Jun 2018
- Primary completion31 Dec 2019
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study was designed as a randomized controlled and crossover trial to evaluate the evaluate the effect of the Work-MATE program on occupational performance at work of adults with ADHD. The first Intervention Group (A) received the Work-MATE intervention. After a crossover switching trial, the second Intervention Group (B) received the Work-MATE intervention in order. All evaluations were online, in similar environmental conditions. The Ethics Committee of the University of Haifa approved the study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Rosenblum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Rosenblum, University of Haifa
- Investigators
- Sara Rosenblum, Prof., Study director, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270226
- Sponsor's protocol ID
- Work-MATE
- Status last verified
- Feb 2022
- First submitted
- 12 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating a Metacognitive ADHD Telehealth Intervention for Work-performance Enhancement (Work-MATE) Amongst Adults With ADHD
- ClinicalTrials.gov ID
- NCT05270226
- Acronym / sponsor ID
- Work-MATE
- Conditions
- ADHD
- Keywords
- Work Performance, Occupational Performance, Executive Functions, Quality of Life, Organization in Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Sara RosenblumUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 8 Mar 2022 (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.
Adults with Attention-deficit hyperactivity disorder (ADHD) experience poor occupational performance at work compare to adults without ADHD, manifested at tendencies toward unemployment, job instability, work accidents, and sickness absences. This poor occupational performance at work may be partly caused by difficulties at executive functions (EF) abilities, and at the ability to set and attain goal directed work-activities at a satisfactory manner. Therefore, improvement at those abilities may followed by occupational performance at work enhancement of adults with ADHD. Such improvement may enhance adults with ADHD quality of life.
Despite the wide-ranging implications of poor occupational performance at work of adults with ADHD, treatments which focus at this component improvement among adults with ADHD are lack.
The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) is an innovative program that aim to improve occupational performance at work of adults with ADHD, by enhancing their EF abilities, self-awareness, and personal strategy use.
This program was established based on existing fundamental models and approach, (1) The World Health Organization's international classification of functioning, disability and health (ICF) (WHO, 2001), (2) Person-Environment-Occupation-Performance model (Baum, Christiansen, \& Bass-Haugen, 2015) (3) The Dynamic Interactional Model of cognition (DIM; Toglia, 2018) and the Multicontex approach (Toglia, 2018) which based on the it, and (4) Telehealth as service-delivering model.
The Work-MATE aim to promote self-awareness and self-generation of personal strategies and increase efficiency strategy use across meaningful purposeful everyday work activities (i.e., goal directed work-activities). It is a short, synchronous and hybrid teleintervention program of eleven 1-hour weekly individual sessions, focused directly on occupational performance at work enhancement of adults with ADHD.
Detailed description
Research Aim:
To develop and evaluate effectiveness of Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE), of adults with ADHD.
Hypotheses:
The study sample (n=46) includes adults with ADHD, after confirmation of inclusion and exclusion criteria and symptoms consistency of ADHD. Participants enrolled randomly into two groups:
- Group A (n=31)- received treatment immediately after the first assessment.
- Group B (n =16)- was reassessed 10-11 weeks after the first assessment (the length of the treatment process), and then received treatment.
Both groups were reassessed at the end of the treatment (second assessment for group A and third assessment for group B). An additional assessment was performed three months after the end of treatment.
The hypotheses are presented in three stages:
Stage 1:
- A comparison of the characteristics of study groups (A and B) participants as a preliminary stage to their unification as one group (n=46). Hypothesis 1: Differences will not be found in the demographic and occupational characteristics of participants when assessed using demographic and occupational questionnaires, and the ADHD characteristics using the Brown Attention-Deficit Disorder Scales (BADDS).
- To examine the change in group B (n = 16) prior to treatment.
Hypothesis 2: Differences will not be found between assessment 1 and assessment 2 before the treatment in the following variables:
- a. EF abilities- measured by Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) 2. b. occupational performance at work- evaluated by performance and satisfaction with performance scores as measured with the Canadian Occupational Performance Measure (COPM).
- c. Quality of life- evaluated by Adult ADHD Quality of Life Questionnaire (AAQoL).
- d. Organization in time ability- evaluated by Time Organization and Participation Scale (TOPS).
- e. ADHD characteristics- evaluated by BADDS questionnaire.
Stage 2: Effectiveness of the Treatment
- Examination of the effectiveness of the treatment process within both study groups (A and B) (n = 46), before and after treatment, and three months after its completion.
Hypothesis 3: Differences will be found in both study groups (research and comparison) before and after treatment, and after a follow-up assessment three months later, regarding:
- a. EF abilities- measured by BRIEF-A. 3. b. occupational performance at work- evaluated by performance and satisfaction with performance scores as measured with the COPM.
- c. Quality of life- evaluated by AAQoL. 3. d. Organization in time ability- evaluated by TOPS. 3. e. ADHD characteristics- evaluated by BADDS questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study was designed as a randomized controlled and crossover trial to evaluate the evaluate the effect of the Work-MATE program on occupational performance at work of adults with ADHD. The first Intervention Group (A) received the Work-MATE intervention. After a crossover switching trial, the second Intervention Group (B) received the Work-MATE intervention in order. All evaluations were online, in similar environmental conditions. The Ethics Committee of the University of Haifa approved the study.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE)After being randomly allocated, group A participants had first evaluation (out of 3, pre-intervention) and immidiatlly recived Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE). |
| Group B | Experimental | Behavioral: The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE)After being randomly allocated, group B participants had first evaluation (out of 4), then waiting-phase of 10-11 weeks, and after second evaluation (pre-intervention) start Work-MATE intervention process. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants worked at least 3 months at the same workplace.
- Participants had formal medical diagnosis of ADHD.
- Symptoms consistent with ADHD were confirmed either by the Adult ADHD Self-Report Scale (ASRS) version 1.1 (Kessler et al., 2005) final score or by medium-to-high probability of ADHD according to the BADDS (Brown, 2012).
- Participants had at least one EF deficit according to the BRIEF-A (Roth et al., 2005).
- Participants not receiving any functional additional treatment during the study period.
Key exclusion criteria (1 listed)
- People who self-reported comorbid mental health disorders, motor or neurological disabilities, chronic diseases, or significant injuries.
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 |
|---|---|---|
| The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE)The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) is an innovative program that aim to improve occupational performance at work of adults with ADHD, by enhancing their EF abilities, self-awareness, and personal strategy use. The Work-MATE is a short, synchronous and hybrid teleintervention program of eleven 1-hour weekly individual sessions. It offers a written standardized protocol, which include uniform structure of each intervention session and pool of therapy aids (for self-tailored matching by occupational therapists). | Behavioural | Group A, Group B |
Primary outcome
Change from Baseline Canadian Occupational Performance Measure (COPM) at 3 and 6 months
Time frame: Measure 1 (baseline; at third intervention meeting), measure 2 (after intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
COPM used to evaluate self-perception of occupational performance at work. During semi-structured interview at the third session of intervention, the participant was asked to identify two meaningful activities for which he perceived the greatest performance problems during work, or activities that influence his occupational performance at work. Those two activities were set up as the two intervention goals. Participants rated each activity for performance from 1 (not able to do at all) to 10 (able to do extremely well) and similarly for satisfaction with performance. Significant improvement was considered as a change of at least two points between measures.
Change from Baseline Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) at 3 and 6 months
Time frame: Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
BRIEF-A measure EF abilities following the intervention. The score includes a global executive composite (GEC) index that represents the overall EF score, composed of a behavioral regulation index (BRI) score and a metacognition index (MI) score with nine nonoverlapping score scales. Scores of 65 or more for each index or scale indicate a clinical deficit.
3 secondary outcomes
Change from Baseline Adult ADHD Quality of Life Questionnaire (AAQoL) at 3 and 6 months
Time frame: Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
Change from Baseline Time Organization and Participation Scale (TOPS) at 3 and 6 months
Time frame: Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
Change from Baseline Brown Attention-Deficit Disorder Scales (BADDS) at 3 and 6 months
Time frame: Measure 1 (baseline; 1 week before the beginning of the intervention), measure 2 (after the intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)
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 8 Mar 2022.
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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.
Sara Rosenblum, Prof. study director
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Metacognitive ADHD Telehealth intervention for Work-performance Enhancement (Work-MATE) in people with ADHD, run by Sara Rosenblum at 1 site in Israel.
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 1 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 8 Mar 2022. 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 Israel. 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?
Change from Baseline Canadian Occupational Performance Measure (COPM) at 3 and 6 months (time frame: Measure 1 (baseline; at third intervention meeting), measure 2 (after intervention completion; approximately 3 months from baseline), measure 3 (approximately 6 months from baseline)). The study lists 2 primary outcomes in all. 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 8 Mar 2022.