Interprofessional EducationINCAsENCT04204109
Interprofessional Versus Monoprofessional Case-based Learning in Childhood Cancer
A study testing Interprofessional case-based learning in people with Interprofessional Education and Continuing Professional Development, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Interprofessional education in childhood cancer is a multifaceted field. It involves multiple healthcare professionals with general and specialised knowledge and skills. Complex treatment, care and rehabilitation require continuous professional development and maintenance of healthcare professionals' competencies in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Interprofessional Education, Continuing Professional Development, Education
- What is being tested?
- Interprofessional case-based learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Feb 2020to 5 May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthcare professionals at the in-patient department for children and adolescents with cancer
- Healthcare professionals at the in-patient department for transplantation of children and adolescents with cancer
- Healthcare professionals at the out-patient departments for children and adolescents with cancer department
- Healthcare professionals affiliated with Juliane Marie Centre at Rigshospitalet
- Employees in a supportive function to the department for children and adolescents with cancer, such as psychologists, priests, pedagogues, social workers, experts in pain relief in children, physiotherapists, occupational therapists and dieticians.
- Teachers employed at a local public school but have their main working hours at the department.
Who cannot join
- Staff taking part in the intervention or in the planning of the intervention
- Management with staff responsibilities
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Juliane Marie Centre for Women, Children and Reproduction (JMC), Rigshospitalet (RH), Copenhagen University Hospital, Denmark.
Copenhagen, 2100
About this study
Official title: Interprofessional Versus Monoprofessional Case-based Learning in Childhood Cancer and the Effect on Healthcare Professionals' Interprofessional Attitudes: a Randomized Trial
Interprofessional education in childhood cancer is a multifaceted field. It involves multiple healthcare professionals with general and specialised knowledge and skills. Complex treatment, care and rehabilitation require continuous professional development and maintenance of healthcare professionals' competencies in their own professional field. Limited knowledge exists on comparing interprofessional and monoprofessional education and only few randomised studies have evaluated the effectiveness and efficiency of interprofessional education. One clinical area among others where healthcare professionals collaborate is in gastrointestinal toxicities and side effects. These are frequent and potentially severe clinical problems in childhood cancer that involve multiple healthcare professionals.
Objectives: To study the effect of interprofessional versus monoprofessional case-based learning on healthcare professionals' attitudes on interprofessional learning and collaboration.
Read more
Trial design: single centre investigator-initiated cluster randomized trial
Methods:
Participants: Employees with patient-related work at the childhood cancer departments and affiliated with childhood cancer at Rigshospitalet are eligible for inclusion. The setting is the childhood cancer department.
Outcome: The primary outcome is to improve healthcare professionals' interprofessional attitude.
Measurements:
The primary outcome is attitudes measured by the Assessment of Interprofessional Team Collaboration Scale (AITCS). Secondary outcome is Readiness for Interprofessional Learning Scale (RIPLS) Questionnaire, and Safety Attitudes Questionnaire (SAQ). Knowledge will be measured by written test as multiple choice questionnaire (MCQ).
Timepoints: The self-reported questionnaires will be distributed to the participants approximately one month before and one month after the educational intervention. On the day of the educational intervention, participants will answer the multiple choice questionnaire.
Analysis: Linear mixed regression will be used to compare differences in mean scores postintervention, adjusted for differences between the two groups.
Results: We hypothesise that interprofessional case-based learning positively affects the healthcare professionals' interprofessional attitudes.
- Conditions
- Interprofessional Education, Continuing Professional Development, Education, Case-based Learning
- Being tested
- Interprofessional case-based learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interprofessional case-based learningOther
The trial is an educational intervention where groups of healthcare professionals receive the same case-based learning: one group receives case-based learning with healthcare professionals of various professional backgrounds (experimental) versus another group receiving case-based learning with healthcare professionals exclusively of the same professional background (control).
The educational intervention consists of a case that is developed for the purpose of the intervention.
The participants in the experimental group will be randomised into six teams who will receive interprofessional case-based learning. The experimental group will be made up of healthcare professionals from various groups. The participants in the control group will be randomised in groups of one profession
| Study group | Role | What they receive |
|---|---|---|
| Interprofessional case-based learning | Experimental | The experimental intervention will be the interprofessional group receiving case-based learning about gastro-intestinal toxicities and side effects of children and adolescents with cancer. Receives: Other: Interprofessional case-based learning |
| Monoprofessional case-based learning | Active comparator | The control group is the monoprofessional group that will receive the same case-based learning as the intervention group. Receives: Other: Interprofessional case-based learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the participants' interprofessional collaboration
Primary outcome: change in the participants' interprofessional attitude to collaboration measured by Assessment of interprofessional Team Collaboration Scale (AITCS). The scale contains three main categories: 1)Partnership/shared decision making (19 items), 2) Collaboration (11 items), 3) Coordination (7 items) that are rated on a scale from 1-5 (1= "never"; 2= "rarely"; 3="occasionally"; 4="most of the time"; 5="Always"). The scales procedures scores from 48 to 240. Higher scores indicate a better outcome
Measured: Measured 1 month before intervention and 1-3 months after intervention in both groups
Secondary outcomes (2)
Change in the participants' interprofessional attitudes
Secondary outcome: measured by Change in Readiness for Interprofessional Learning Survey (RIPLS). 29 items on a five-point scale 4 subscales; 1)Teamwork and collaboration, 2)Negative professional identity, 3)Positive professional identity, 4)Roles and responsibility.
The items are rated on a scale from 1-5 (1= "strongly disagree"; 2= "agree"; 3="undecided"; 4="agree"; 5="strongly agree"). Higher scores indicate a better outcome
Measured: Measured 1 month before intervention and 1-3 months after intervention in both groups
Change in participants' knowledge of gastrointestinal toxicities and side effects
measured by written test as multiple choice questionnaire (MCQ). There are three options to chose from in this multiple choice questionnaire, one correct answer and two wrong answers. This MCQ is developed and validated for the purpose of this particular education session
Measured: measured at the actual intervention day 30 minutes prior to the session and immediately after the education session (maximum 15 minutes after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start25 Feb 2020
- Primary completion11 Mar 2020
- Study completion5 May 2020
Why it stopped: Covid 19 and subsequent cancellation of all meeting activity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Interprofessional EducationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Child Cancer Foundation
- Responsible party
- Principal investigator, Martha Krogh Topperzer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jette L Sørensen, Study chair, Juliane Marie Centre for Women, Children and Reproduction (JMC), Rigshospitalet (RH), Copenhagen University Hospital, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204109
- Sponsor's protocol ID
- Mtopperzer
- Acronym
- INCAsE
- Status last verified
- Sep 2020
- First submitted
- 10 Dec 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Randomisation is performed centrally by a computer-generated allocation sequence concealed for the investigators
Publications
Reeves S, Pelone F, Harrison R, Goldman J, Zwarenstein M. Interprofessional collaboration to improve professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD000072. doi: 10.1002/14651858.CD000072.pub3.
PubMed 28639262Reeves S, Zwarenstein M, Goldman J, Barr H, Freeth D, Hammick M, Koppel I. Interprofessional education: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD002213. doi: 10.1002/14651858.CD002213.pub2.
PubMed 18254002Marcussen M, Norgaard B, Borgnakke K, Arnfred S. Interprofessional clinical training in mental health improves students' readiness for interprofessional collaboration: a non-randomized intervention study. BMC Med Educ. 2019 Jan 18;19(1):27. doi: 10.1186/s12909-019-1465-6.
PubMed 30658648Ruebling I, Pole D, Breitbach AP, Frager A, Kettenbach G, Westhus N, Kienstra K, Carlson J. A comparison of student attitudes and perceptions before and after an introductory interprofessional education experience. J Interprof Care. 2014 Jan;28(1):23-7. doi: 10.3109/13561820.2013.829421. Epub 2013 Sep 3.
PubMed 24000881Norgaard B, Ammentorp J, Kofoed PE, Kyvik KO. Training improves inter-collegial communication. Clin Teach. 2012 Jun;9(3):173-7. doi: 10.1111/j.1743-498X.2011.00525.x.
PubMed 22587317Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
PubMed 18824488Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and Statistics in Medicine. Stat Med. 2007 Jan 15;26(1):2-19. doi: 10.1002/sim.2731.
PubMed 17136746Ukoumunne OC, Gulliford MC, Chinn S, Sterne JA, Burney PG. Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. Health Technol Assess. 1999;3(5):iii-92. No abstract available.
PubMed 10982317Allen LM, Palermo C, Armstrong E, Hay M. Categorising the broad impacts of continuing professional development: a scoping review. Med Educ. 2019 Nov;53(11):1087-1099. doi: 10.1111/medu.13922. Epub 2019 Aug 8.
PubMed 31396999Thistlethwaite J. Interprofessional education: 50 years and counting. Med Educ. 2016 Nov;50(11):1082-1086. doi: 10.1111/medu.12959. No abstract available.
PubMed 27762034Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, Guthrie B, Lester H, Wilson P, Kinmonth AL. Designing and evaluating complex interventions to improve health care. BMJ. 2007 Mar 3;334(7591):455-9. doi: 10.1136/bmj.39108.379965.BE.
PubMed 17332585Topperzer MK, Larsen HB, Hoffmann M, Schmiegelow K, Lausen B, Madsen M, Roland P, Sorensen JL. Response to: Patient-centred medical education: A proposed definition. Med Teach. 2020 Mar;42(3):360-361. doi: 10.1080/0142159X.2019.1625315. Epub 2019 Jun 12. No abstract available.
PubMed 31185784Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.
PubMed 22951546Reaman GH. Pediatric cancer research from past successes through collaboration to future transdisciplinary research. J Pediatr Oncol Nurs. 2004 May-Jun;21(3):123-7. doi: 10.1177/1043454204264406.
PubMed 15296038Christiansen HL, Bingen K, Hoag JA, Karst JS, Velazquez-Martin B, Barakat LP. Providing Children and Adolescents Opportunities for Social Interaction as a Standard of Care in Pediatric Oncology. Pediatr Blood Cancer. 2015 Dec;62 Suppl 5:S724-49. doi: 10.1002/pbc.25774.
PubMed 26700923
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interprofessional Versus Monoprofessional Case-based Learning in Childhood Cancer and the Effect on Healthcare Professionals' Interprofessional Attitudes: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04204109
- Acronym / sponsor ID
- INCAsE / Mtopperzer
- Conditions
- Interprofessional Education, Continuing Professional Development, Education, Case-based Learning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid 19 and subsequent cancellation of all meeting activity
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Child Cancer Foundation
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 18 Dec 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.
Interprofessional education in childhood cancer is a multifaceted field. It involves multiple healthcare professionals with general and specialised knowledge and skills. Complex treatment, care and rehabilitation require continuous professional development and maintenance of healthcare professionals' competencies in their own professional field. Limited knowledge exists on comparing interprofessional and monoprofessional education and only few randomised studies have evaluated the effectiveness and efficiency of interprofessional education. One clinical area among others where healthcare professionals collaborate is in gastrointestinal toxicities and side effects. These are frequent and potentially severe clinical problems in childhood cancer that involve multiple healthcare professionals.
Objectives: To study the effect of interprofessional versus monoprofessional case-based learning on healthcare professionals' attitudes on interprofessional learning and collaboration.
Trial design: single centre investigator-initiated cluster randomized trial
Methods:
Participants: Employees with patient-related work at the childhood cancer departments and affiliated with childhood cancer at Rigshospitalet are eligible for inclusion. The setting is the childhood cancer department.
Outcome: The primary outcome is to improve healthcare professionals' interprofessional attitude.
Measurements:
The primary outcome is attitudes measured by the Assessment of Interprofessional Team Collaboration Scale (AITCS). Secondary outcome is Readiness for Interprofessional Learning Scale (RIPLS) Questionnaire, and Safety Attitudes Questionnaire (SAQ). Knowledge will be measured by written test as multiple choice questionnaire (MCQ).
Timepoints: The self-reported questionnaires will be distributed to the participants approximately one month before and one month after the educational intervention. On the day of the educational intervention, participants will answer the multiple choice questionnaire.
Analysis: Linear mixed regression will be used to compare differences in mean scores postintervention, adjusted for differences between the two groups.
Results: We hypothesise that interprofessional case-based learning positively affects the healthcare professionals' interprofessional attitudes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interprofessional case-based learning | Experimental | Other: Interprofessional case-based learningThe experimental intervention will be the interprofessional group receiving case-based learning about gastro-intestinal toxicities and side effects of children and adolescents with cancer. |
| Monoprofessional case-based learning | Active comparator | Other: Interprofessional case-based learningThe control group is the monoprofessional group that will receive the same case-based learning as the intervention group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Healthcare professionals at the in-patient department for children and adolescents with cancer
- Healthcare professionals at the in-patient department for transplantation of children and adolescents with cancer
- Healthcare professionals at the out-patient departments for children and adolescents with cancer department
- Healthcare professionals affiliated with Juliane Marie Centre at Rigshospitalet
- Employees in a supportive function to the department for children and adolescents with cancer, such as psychologists, priests, pedagogues, social workers, experts in pain relief in children, physiotherapists, occupational therapists and dieticians.
Key exclusion criteria (3 listed)
- Staff taking part in the intervention or in the planning of the intervention
- Management with staff responsibilities
- Lack of informed consent
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 |
|---|---|---|
| Interprofessional case-based learningThe trial is an educational intervention where groups of healthcare professionals receive the same case-based learning: one group receives case-based learning with healthcare professionals of various professional backgrounds (experimental) versus another group receiving case-based learning with healthcare professionals exclusively of the same professional background (control). The educational intervention consists of a case that is developed for the purpose of the intervention. The participants in the experimental group will be randomised into six teams who will receive interprofessional case-based learning. The experimental group will be made up of healthcare professionals from various groups. The participants in the control group will be randomised in groups of one profession | Other | Interprofessional case-based learning, Monoprofessional case-based learning |
Primary outcome
Change in the participants' interprofessional collaboration
Time frame: Measured 1 month before intervention and 1-3 months after intervention in both groups
Primary outcome: change in the participants' interprofessional attitude to collaboration measured by Assessment of interprofessional Team Collaboration Scale (AITCS). The scale contains three main categories: 1)Partnership/shared decision making (19 items), 2) Collaboration (11 items), 3) Coordination (7 items) that are rated on a scale from 1-5 (1= "never"; 2= "rarely"; 3="occasionally"; 4="most of the time"; 5="Always"). The scales procedures scores from 48 to 240. Higher scores indicate a better outcome
2 secondary outcomes
Change in the participants' interprofessional attitudes
Time frame: Measured 1 month before intervention and 1-3 months after intervention in both groups
Change in participants' knowledge of gastrointestinal toxicities and side effects
Time frame: measured at the actual intervention day 30 minutes prior to the session and immediately after the education session (maximum 15 minutes after)
Results and safety
The study was stopped early (reason given: Covid 19 and subsequent cancellation of all meeting activity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 28639262Reeves S, Pelone F, Harrison R, Goldman J, Zwarenstein M. Interprofessional collaboration to improve professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD000072. doi: 10.1002/14651858.CD000072.pub3.
- Background: PubMed 18254002Reeves S, Zwarenstein M, Goldman J, Barr H, Freeth D, Hammick M, Koppel I. Interprofessional education: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD002213. doi: 10.1002/14651858.CD002213.pub2.
- Background: PubMed 30658648Marcussen M, Norgaard B, Borgnakke K, Arnfred S. Interprofessional clinical training in mental health improves students' readiness for interprofessional collaboration: a non-randomized intervention study. BMC Med Educ. 2019 Jan 18;19(1):27. doi: 10.1186/s12909-019-1465-6.
- Background: PubMed 24000881Ruebling I, Pole D, Breitbach AP, Frager A, Kettenbach G, Westhus N, Kienstra K, Carlson J. A comparison of student attitudes and perceptions before and after an introductory interprofessional education experience. J Interprof Care. 2014 Jan;28(1):23-7. doi: 10.3109/13561820.2013.829421. Epub 2013 Sep 3.
- Background: PubMed 22587317Norgaard B, Ammentorp J, Kofoed PE, Kyvik KO. Training improves inter-collegial communication. Clin Teach. 2012 Jun;9(3):173-7. doi: 10.1111/j.1743-498X.2011.00525.x.
- Background: PubMed 18824488Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
- Background: PubMed 17136746Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and Statistics in Medicine. Stat Med. 2007 Jan 15;26(1):2-19. doi: 10.1002/sim.2731.
- Background: PubMed 10982317Ukoumunne OC, Gulliford MC, Chinn S, Sterne JA, Burney PG. Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. Health Technol Assess. 1999;3(5):iii-92. No abstract available.
- Background: PubMed 31396999Allen LM, Palermo C, Armstrong E, Hay M. Categorising the broad impacts of continuing professional development: a scoping review. Med Educ. 2019 Nov;53(11):1087-1099. doi: 10.1111/medu.13922. Epub 2019 Aug 8.
- Background: PubMed 27762034Thistlethwaite J. Interprofessional education: 50 years and counting. Med Educ. 2016 Nov;50(11):1082-1086. doi: 10.1111/medu.12959. No abstract available.
- Background: PubMed 17332585Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, Guthrie B, Lester H, Wilson P, Kinmonth AL. Designing and evaluating complex interventions to improve health care. BMJ. 2007 Mar 3;334(7591):455-9. doi: 10.1136/bmj.39108.379965.BE.
- Background: PubMed 31185784Topperzer MK, Larsen HB, Hoffmann M, Schmiegelow K, Lausen B, Madsen M, Roland P, Sorensen JL. Response to: Patient-centred medical education: A proposed definition. Med Teach. 2020 Mar;42(3):360-361. doi: 10.1080/0142159X.2019.1625315. Epub 2019 Jun 12. No abstract available.
- Individual participant dataSharing planned: No. Randomisation is performed centrally by a computer-generated allocation sequence concealed for the investigators
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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.
Jette L Sørensen study chair
Juliane Marie Centre for Women, Children and Reproduction (JMC), Rigshospitalet (RH), Copenhagen University Hospital, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interprofessional case-based learning in people with Interprofessional Education and Continuing Professional Development, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 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: stopped early, as of the sponsor's last update on 9 Sep 2020. 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 Denmark. 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 was stopped early (reason given: Covid 19 and subsequent cancellation of all meeting activity). 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?
Change in the participants' interprofessional collaboration (time frame: Measured 1 month before intervention and 1-3 months after intervention in both groups). 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 NCT04204109, which also lists 31 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 9 Sep 2020.