Advanced Cardiac Life SupportNCT04364529
Implementation of Pit Crew Resuscitation Model on the Training of Advanced Life Support: a Randomized Controlled Study
A study testing The pit crew model in people with Advanced Cardiac Life Support, run by Turku University Hospital at 1 site in Finland.
Trial summary
In this study, a pit crew model is implemented in advanced life support (ALS) simulation training to student groups. The hypothesis is that the tactic model could help to maintain the CPR skills during the six month follow-up period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cardiac Life Support
- What is being tested?
- The pit crew model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFinland
- Study dates
- 14 Aug 2017to 30 Jan 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- medical student (fourth or fifth year)
- paramedic student (third or fourth year)
- nurse student (third or fourth year)
- participated simulated ALS-situations e.g. in school before
Who cannot join
- participated more than two real-life ALS-situations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pit Crew Resuscitation Model on Advanced Life Support Skills in a Simulated Setting: a Randomized Controlled Trial
In this study, a pit crew model is implemented in advanced life support (ALS) simulation training to student groups. The hypothesis is that the tactic model could help to maintain the CPR skills during the six month follow-up period.
Read the detailed description
Introduction
Technical skills (TS) and non-technical skills (NTS) are two sets of skills required by Crisis resource management (CRM). Sudden cardiac arrest is a time-critical emergency situation in which both skills are needed - it's handled by a team rather than by individual health-care workers.
Because of the relatively rare nature of cardiac arrests in many wards and clinics, regular resuscitation training is necessary. However, the main part of the training is traditionally emphasized to technical skills. The recent research findings of the authors suggest that the TS and NTS seem to associate in a real life resuscitation. The authors wanted to investigate if pre-allocated tasks and positions (a pit crew model) helps to perform better ALS performance and helps to maintain the skills in simulated ALS situations.
Simulation-based education (SBE) is a key tool for teaching CPR. It has demonstrated its effectiveness in promoting skill acquisition and has been suggested as an ideal tool for teaching medical skills allowing learners to engage actively in their learning process while doing no harm to their patients but its effectiveness on improving anesthesiologists NTS is unclear as the matter has not been studied. SBE is particularly good method to create trainees a realistic medical crisis situation (scenario) created within a physical space (simulator) replicating the real environment where trainees goal is to solve the problem, do the diagnose and treat the patient. Afterwards, the simulation debriefing is an crucial part of the whole letting trainees and the instructor to finish the learning process. Traditionally such training has been a standard in professions characterized by high risk caused by 'human factor' such as in aviation and other high risk industries. On the other hand the benefit for maintaining resuscitation skills learned after single SBE is modest thus short - only a few minutes a week - but frequent SBE appears to facilitate transfer of new knowledge and skills into clinical practice. SBE has been shown to improve the satisfaction of learners and skill performance in the simulated environment but it's still unclear whether it improves the patient outcome. Simulation training is expensive though so other teaching methods like mental practice and e-learning could be useful alongside it.
Catchpole and colleagues aimed to improve the quality and safety of handover of pediatric patients from surgery to intensive care using the analogy of a Formula 1 pit stop and expertise from aviation. They introduced a new handover protocol which led to improvements in all aspects of the critical situation. Based on he same idea, a novel resuscitation tactic model (a pit crew model) was developed which predetermines the roles and responsibilities of each resuscitation team members.
Purpose and hypothesis
In this study, advanced life support (ALS) skills are trained to medical students (26 persons), student nurses (52 persons) and student paramedics (26 persons). A pit crew model is taught for every other four-person resuscitation team (intervention group) and for every other group not (control group). The hypothesis is that the pit crew model could improve the quality of advanced life support immidiately after the ALS education (primary outcome) and help to maintain the ALS metrics during the follow-up period (secondary outcome). Additionally, we analyze if the pit-crew model help team physician to take hands free earlier.
Methods
The students are divided into 26 four-person resuscitation teams: one medical student, one student paramedic and two student nurses. Each resuscitation team participates on an ALS course which is based on the 2015 European (the test group) Guidelines for Resuscitation. The participants are randomized in two study arms: intervention and control. The intervention group receives ALS education according the pit crew model while the control Group received traditional ALS training. In the end of the ALS course, the resuscitation team performs a simulated resuscitation situation which is video-recorded. The TS and NTS are later analyzed by the medical professionals using detailed instrument. The hands-on ratio and the time when the team physician takes hands-free analyzed visually from the videos. Later, after six months of the ALS course, the participants will run through a simulated CPR-situation again and the data will be collected as the the same way.
The primary outcome was the difference in the total assessment score between the intervention and control groups after 6-months follow-up. The secondary outcome was the difference in ALS skills after 6-months follow-up.
Ethics The study protocol was approved by the Ethics Committee of Turku University (31/2016).
- Conditions
- Advanced Cardiac Life Support
- Being tested
- The pit crew model
- Keywords
- non-technical skills, technical skills, Simulation Training, Patient simulation, CRM, Crew Recourse Management, team work, human factors, pit crew model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The pit crew modelOther
The pit crew model
| Study group | Role | What they receive |
|---|---|---|
| Intervention (pit crew model group) | Experimental | 13 groups being taught the pit crew model Receives: Other: The pit crew model |
| control (traditional ALS education) | No intervention | 13 groups being taught along traditional ALS education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the total assessment score between the intervention and control groups after 6-months follow-up.
The NTS and TS are evaluated with a valid measurement tool developed for this purpose by two independent evaluators. The instrument consist of 59 items (28 items for TS and the rest for NTS) and the scale of +2 to -2 is used. Additionally, raters gave a total assessment score of performance on a scale from 0 to 10 (0=poor, 10=excellent)
Measured: 6 months follow-up
Secondary outcomes (1)
The difference in ALS skills after 6-months follow-up.
The NTS and TS are evaluated with a valid measurement tool developed for this purpose by two independent evaluators. The instrument consist of 59 items (28 items for TS and the rest for NTS) and the scale of +2 to -2 is used.
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start14 Aug 2017
- Primary completion30 Dec 2018
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Advanced Cardiac Life SupportStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- The students are divided into 26 four-person resuscitation teams: one medical student, one student paramedic and two student nurses. These 26 teams are randomidez in two study arms: intervention (pit-crew group) and the control Group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Turku University of Applied Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364529
- Sponsor's protocol ID
- T212/2016
- Status last verified
- Nov 2021
- First submitted
- 4 Mar 2020
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants in the videos can be recognized. Video material can not be shared due to patient privacy. Other data is possible to share.
Publications
Cheng A, Auerbach M, Hunt EA, Chang TP, Pusic M, Nadkarni V, Kessler D. Designing and conducting simulation-based research. Pediatrics. 2014 Jun;133(6):1091-101. doi: 10.1542/peds.2013-3267. Epub 2014 May 12.
PubMed 24819576Rovamo L, Nurmi E, Mattila MM, Suominen P, Silvennoinen M. Effect of a simulation-based workshop on multidisplinary teamwork of newborn emergencies: an intervention study. BMC Res Notes. 2015 Nov 12;8:671. doi: 10.1186/s13104-015-1654-2.
PubMed 26563963Cheng A, Lang TR, Starr SR, Pusic M, Cook DA. Technology-enhanced simulation and pediatric education: a meta-analysis. Pediatrics. 2014 May;133(5):e1313-23. doi: 10.1542/peds.2013-2139. Epub 2014 Apr 14.
PubMed 24733867Eppich WJ, Nypaver MM, Mahajan P, Denmark KT, Kennedy C, Joseph MM, Kim I. The role of high-fidelity simulation in training pediatric emergency medicine fellows in the United States and Canada. Pediatr Emerg Care. 2013 Jan;29(1):1-7. doi: 10.1097/PEC.0b013e31827b20d0.
PubMed 23283253Asarbakhsh M, Sandars J. E-learning: the essential usability perspective. Clin Teach. 2013 Feb;10(1):47-50. doi: 10.1111/j.1743-498X.2012.00627.x.
PubMed 23294744Didwania A, McGaghie WC, Cohen ER, Butter J, Barsuk JH, Wade LD, Chester R, Wayne DB. Progress toward improving the quality of cardiac arrest medical team responses at an academic teaching hospital. J Grad Med Educ. 2011 Jun;3(2):211-6. doi: 10.4300/JGME-D-10-00144.1.
PubMed 22655144Wayne DB, Didwania A, Feinglass J, Fudala MJ, Barsuk JH, McGaghie WC. Simulation-based education improves quality of care during cardiac arrest team responses at an academic teaching hospital: a case-control study. Chest. 2008 Jan;133(1):56-61. doi: 10.1378/chest.07-0131. Epub 2007 Jun 15.
PubMed 17573509Lorello GR, Hicks CM, Ahmed SA, Unger Z, Chandra D, Hayter MA. Mental practice: a simple tool to enhance team-based trauma resuscitation. CJEM. 2016 Mar;18(2):136-42. doi: 10.1017/cem.2015.4. Epub 2015 Apr 10.
PubMed 25860822Nicastro E, Lo Vecchio A, Liguoro I, Chmielewska A, De Bruyn C, Dolinsek J, Doroshina E, Fessatou S, Pop TL, Prell C, Tabbers MM, Tavares M, Urenden-Elicin P, Bruzzese D, Zakharova I, Sandhu B, Guarino A. The Impact of E-Learning on Adherence to Guidelines for Acute Gastroenteritis: A Single-Arm Intervention Study. PLoS One. 2015 Jul 6;10(7):e0132213. doi: 10.1371/journal.pone.0132213. eCollection 2015.
PubMed 26148301Catchpole K, Mishra A, Handa A, McCulloch P. Teamwork and error in the operating room: analysis of skills and roles. Ann Surg. 2008 Apr;247(4):699-706. doi: 10.1097/SLA.0b013e3181642ec8.
PubMed 18362635Mduma E, Ersdal H, Svensen E, Kidanto H, Auestad B, Perlman J. Frequent brief on-site simulation training and reduction in 24-h neonatal mortality--an educational intervention study. Resuscitation. 2015 Aug;93:1-7. doi: 10.1016/j.resuscitation.2015.04.019. Epub 2015 May 6.
PubMed 25957942Gjeraa K, Moller TP, Ostergaard D. Efficacy of simulation-based trauma team training of non-technical skills. A systematic review. Acta Anaesthesiol Scand. 2014 Aug;58(7):775-87. doi: 10.1111/aas.12336. Epub 2014 May 14.
PubMed 24828210Issenberg SB, McGaghie WC, Petrusa ER, Lee Gordon D, Scalese RJ. Features and uses of high-fidelity medical simulations that lead to effective learning: a BEME systematic review. Med Teach. 2005 Jan;27(1):10-28. doi: 10.1080/01421590500046924.
PubMed 16147767
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pit Crew Resuscitation Model on Advanced Life Support Skills in a Simulated Setting: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04364529
- Acronym / sponsor ID
- T212/2016
- Conditions
- Advanced Cardiac Life Support
- Keywords
- non-technical skills, technical skills, Simulation Training, Patient simulation, CRM, Crew Recourse Management, team work, human factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Turku University of Applied Sciences
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 28 Apr 2020 (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.
In this study, a pit crew model is implemented in advanced life support (ALS) simulation training to student groups. The hypothesis is that the tactic model could help to maintain the CPR skills during the six month follow-up period.
Detailed description
Introduction
Technical skills (TS) and non-technical skills (NTS) are two sets of skills required by Crisis resource management (CRM). Sudden cardiac arrest is a time-critical emergency situation in which both skills are needed - it's handled by a team rather than by individual health-care workers.
Because of the relatively rare nature of cardiac arrests in many wards and clinics, regular resuscitation training is necessary. However, the main part of the training is traditionally emphasized to technical skills. The recent research findings of the authors suggest that the TS and NTS seem to associate in a real life resuscitation. The authors wanted to investigate if pre-allocated tasks and positions (a pit crew model) helps to perform better ALS performance and helps to maintain the skills in simulated ALS situations.
Simulation-based education (SBE) is a key tool for teaching CPR. It has demonstrated its effectiveness in promoting skill acquisition and has been suggested as an ideal tool for teaching medical skills allowing learners to engage actively in their learning process while doing no harm to their patients but its effectiveness on improving anesthesiologists NTS is unclear as the matter has not been studied. SBE is particularly good method to create trainees a realistic medical crisis situation (scenario) created within a physical space (simulator) replicating the real environment where trainees goal is to solve the problem, do the diagnose and treat the patient. Afterwards, the simulation debriefing is an crucial part of the whole letting trainees and the instructor to finish the learning process. Traditionally such training has been a standard in professions characterized by high risk caused by 'human factor' such as in aviation and other high risk industries. On the other hand the benefit for maintaining resuscitation skills learned after single SBE is modest thus short - only a few minutes a week - but frequent SBE appears to facilitate transfer of new knowledge and skills into clinical practice. SBE has been shown to improve the satisfaction of learners and skill performance in the simulated environment but it's still unclear whether it improves the patient outcome. Simulation training is expensive though so other teaching methods like mental practice and e-learning could be useful alongside it.
Catchpole and colleagues aimed to improve the quality and safety of handover of pediatric patients from surgery to intensive care using the analogy of a Formula 1 pit stop and expertise from aviation. They introduced a new handover protocol which led to improvements in all aspects of the critical situation. Based on he same idea, a novel resuscitation tactic model (a pit crew model) was developed which predetermines the roles and responsibilities of each resuscitation team members.
Purpose and hypothesis
In this study, advanced life support (ALS) skills are trained to medical students (26 persons), student nurses (52 persons) and student paramedics (26 persons). A pit crew model is taught for every other four-person resuscitation team (intervention group) and for every other group not (control group). The hypothesis is that the pit crew model could improve the quality of advanced life support immidiately after the ALS education (primary outcome) and help to maintain the ALS metrics during the follow-up period (secondary outcome). Additionally, we analyze if the pit-crew model help team physician to take hands free earlier.
Methods
The students are divided into 26 four-person resuscitation teams: one medical student, one student paramedic and two student nurses. Each resuscitation team participates on an ALS course which is based on the 2015 European (the test group) Guidelines for Resuscitation. The participants are randomized in two study arms: intervention and control. The intervention group receives ALS education according the pit crew model while the control Group received traditional ALS training. In the end of the ALS course, the resuscitation team performs a simulated resuscitation situation which is video-recorded. The TS and NTS are later analyzed by the medical professionals using detailed instrument. The hands-on ratio and the time when the team physician takes hands-free analyzed visually from the videos. Later, after six months of the ALS course, the participants will run through a simulated CPR-situation again and the data will be collected as the the same way.
The primary outcome was the difference in the total assessment score between the intervention and control groups after 6-months follow-up. The secondary outcome was the difference in ALS skills after 6-months follow-up.
Ethics The study protocol was approved by the Ethics Committee of Turku University (31/2016).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The students are divided into 26 four-person resuscitation teams: one medical student, one student paramedic and two student nurses. These 26 teams are randomidez in two study arms: intervention (pit-crew group) and the control Group.
| Arm | Type | Receives |
|---|---|---|
| Intervention (pit crew model group) | Experimental | Other: The pit crew model13 groups being taught the pit crew model |
| control (traditional ALS education) | No intervention | –13 groups being taught along traditional ALS education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- medical student (fourth or fifth year)
- paramedic student (third or fourth year)
- nurse student (third or fourth year)
- participated simulated ALS-situations e.g. in school before
Key exclusion criteria (1 listed)
- participated more than two real-life ALS-situations
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 pit crew modelThe pit crew model | Other | Intervention (pit crew model group) |
Primary outcome
The difference in the total assessment score between the intervention and control groups after 6-months follow-up.
Time frame: 6 months follow-up
The NTS and TS are evaluated with a valid measurement tool developed for this purpose by two independent evaluators. The instrument consist of 59 items (28 items for TS and the rest for NTS) and the scale of +2 to -2 is used. Additionally, raters gave a total assessment score of performance on a scale from 0 to 10 (0=poor, 10=excellent)
1 secondary outcome
The difference in ALS skills after 6-months follow-up.
Time frame: 6 months follow-up
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 12 Nov 2021.
- Background: PubMed 24819576Cheng A, Auerbach M, Hunt EA, Chang TP, Pusic M, Nadkarni V, Kessler D. Designing and conducting simulation-based research. Pediatrics. 2014 Jun;133(6):1091-101. doi: 10.1542/peds.2013-3267. Epub 2014 May 12.
- Background: PubMed 26563963Rovamo L, Nurmi E, Mattila MM, Suominen P, Silvennoinen M. Effect of a simulation-based workshop on multidisplinary teamwork of newborn emergencies: an intervention study. BMC Res Notes. 2015 Nov 12;8:671. doi: 10.1186/s13104-015-1654-2.
- Background: PubMed 24733867Cheng A, Lang TR, Starr SR, Pusic M, Cook DA. Technology-enhanced simulation and pediatric education: a meta-analysis. Pediatrics. 2014 May;133(5):e1313-23. doi: 10.1542/peds.2013-2139. Epub 2014 Apr 14.
- Background: PubMed 23283253Eppich WJ, Nypaver MM, Mahajan P, Denmark KT, Kennedy C, Joseph MM, Kim I. The role of high-fidelity simulation in training pediatric emergency medicine fellows in the United States and Canada. Pediatr Emerg Care. 2013 Jan;29(1):1-7. doi: 10.1097/PEC.0b013e31827b20d0.
- Background: PubMed 23294744Asarbakhsh M, Sandars J. E-learning: the essential usability perspective. Clin Teach. 2013 Feb;10(1):47-50. doi: 10.1111/j.1743-498X.2012.00627.x.
- Background: PubMed 22655144Didwania A, McGaghie WC, Cohen ER, Butter J, Barsuk JH, Wade LD, Chester R, Wayne DB. Progress toward improving the quality of cardiac arrest medical team responses at an academic teaching hospital. J Grad Med Educ. 2011 Jun;3(2):211-6. doi: 10.4300/JGME-D-10-00144.1.
- Background: PubMed 17573509Wayne DB, Didwania A, Feinglass J, Fudala MJ, Barsuk JH, McGaghie WC. Simulation-based education improves quality of care during cardiac arrest team responses at an academic teaching hospital: a case-control study. Chest. 2008 Jan;133(1):56-61. doi: 10.1378/chest.07-0131. Epub 2007 Jun 15.
- Background: PubMed 25860822Lorello GR, Hicks CM, Ahmed SA, Unger Z, Chandra D, Hayter MA. Mental practice: a simple tool to enhance team-based trauma resuscitation. CJEM. 2016 Mar;18(2):136-42. doi: 10.1017/cem.2015.4. Epub 2015 Apr 10.
- Background: PubMed 26148301Nicastro E, Lo Vecchio A, Liguoro I, Chmielewska A, De Bruyn C, Dolinsek J, Doroshina E, Fessatou S, Pop TL, Prell C, Tabbers MM, Tavares M, Urenden-Elicin P, Bruzzese D, Zakharova I, Sandhu B, Guarino A. The Impact of E-Learning on Adherence to Guidelines for Acute Gastroenteritis: A Single-Arm Intervention Study. PLoS One. 2015 Jul 6;10(7):e0132213. doi: 10.1371/journal.pone.0132213. eCollection 2015.
- Background: PubMed 18362635Catchpole K, Mishra A, Handa A, McCulloch P. Teamwork and error in the operating room: analysis of skills and roles. Ann Surg. 2008 Apr;247(4):699-706. doi: 10.1097/SLA.0b013e3181642ec8.
- Background: PubMed 25957942Mduma E, Ersdal H, Svensen E, Kidanto H, Auestad B, Perlman J. Frequent brief on-site simulation training and reduction in 24-h neonatal mortality--an educational intervention study. Resuscitation. 2015 Aug;93:1-7. doi: 10.1016/j.resuscitation.2015.04.019. Epub 2015 May 6.
- Background: PubMed 24828210Gjeraa K, Moller TP, Ostergaard D. Efficacy of simulation-based trauma team training of non-technical skills. A systematic review. Acta Anaesthesiol Scand. 2014 Aug;58(7):775-87. doi: 10.1111/aas.12336. Epub 2014 May 14.
- Individual participant dataSharing planned: No. Participants in the videos can be recognized. Video material can not be shared due to patient privacy. Other data is possible to share.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 pit crew model in people with Advanced Cardiac Life Support, run by Turku University Hospital at 1 site in Finland.
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 4 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 12 Nov 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 Finland. 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?
The difference in the total assessment score between the intervention and control groups after 6-months follow-up. (time frame: 6 months follow-up). 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 NCT04364529, which also lists 13 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 12 Nov 2021.