DementiaNCT05246501
The Effect of Simulation in Gaining Skills to Nursing Students
A study testing Simulation and No simulation in people with Dementia and Nursing Caries, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This research is a randomized controlled study conducted to examine the effect of standard patient simulation training in providing nursing students with the ability to care for individuals with dementia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia, Nursing Caries
- What is being tested?
- Simulation and No simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2021to 31 Mar 2022
- 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
- Registered in Hamidiye Faculty of Nursing,
- Taking a psychiatric nursing course in the spring semester of the 2020-2021 academic year,
- Do not have a communication problem at a level that prevents meeting,
- Students who volunteered to participate in the study were included in the study.
Who cannot join
- Not registered in Hamidiye Nursing Faculty,
- Those who did not take a psychiatric nursing course in the spring semester of the 2020-2021 academic year,
- Having a communication problem at a level that prevents meeting,
- Students who did not volunteer to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Saglik Bilimleri University
Istanbul
Aydan Akkurt Yalçıntürk, Lecturer, 05321292497, aydanyalcinturk@gmail.com
Melike Dişsiz, Assoc.prof., 05437995143, melike.dissiz@sbu.edu.tr
About this study
Official title: The Effect of The Standardized Patient Simulation Method on Teaching Nursing Students The Skill Of Caring for Individual Diagnosed With Dementia
This research is a randomized controlled study conducted to examine the effect of standard patient simulation training in providing nursing students with the ability to care for individuals with dementia.
The population of the research consisted of 100 students who were enrolled in the Nursing Faculty and took the "Psychiatric Nursing" course in 2020-2021 academic year. 84 students who were in the universe and completed the pre-test were randomly assigned to the experimental groups that received simulation training and the control groups that did not receive simulation training. The study was completed with 36 students in the experimental group and 35 students in the control group. Research data were collected with "Personal Coding System and Scale Cover Document", "Structured Student Information Form", "Dementia Information Test", "Case Study Form for Individuals Diagnosed with Dementia", "Standardized Mini Mental Examination", "Communication Skills Evaluation Form", Nursing Diagnosis Detection Skill Form" and "Modified-Simulation Effectiveness Tool".
- Conditions
- Dementia, Nursing Caries
- Being tested
- Simulation, No simulation
- Keywords
- Dementia, patient simulation, nursing education, nursing student, simulation training
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationOther
A case scenario with a diagnosis of dementia was used in the study. The scenario consisted of preliminary preparation, implementation and evaluation parts. Psychiatric nursing laboratory practice was applied to the students in the scenario study group. An elderly female standard patient who was diagnosed with dementia took part in the scenario. During this simulation, students were expected to perform mental state examination of the patient, use therapeutic communication techniques and ensure environmental safety.
No simulationOther
The students in the control group did not receive simulation training.
| Study group | Role | What they receive |
|---|---|---|
| Simulation | Experimental | Not described Receives: Other: Simulation |
| control group | Active comparator | Not described Receives: Other: No simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale Cover Document with Personal Coding System
Scale Cover Document with Personal Coding System: A rare code was found with the coding of the first letter of the students' mothers' maiden name, the month of birth, the total number of siblings, the number of sisters, the number of brothers
Measured: for three months
students' introductory characteristics
Students were asked to fill in the pretest and posttest.
Structured Student Information Form: In this form, which was created by scanning the literature, the age, gender, high school graduated, economic status, the presence of a person diagnosed with dementia in the family, the closeness of the individual diagnosed with dementia, the status and duration of living with the individual with dementia, the status and duration of caring for the individual with dementia. There are 12 questions in total, consisting of self-confidence in caregiving, feeling competent and willing, getting information about dementia, sources of information and the first word that comes to mind when dementia is mentioned (Webster and DiBartolo, 2014; Maharaj, 2017).
Measured: before simulation.
Dementia Knowledge
Dementia Knowledge Test: The Dementia Knowledge Test consists of thirty items prepared by the researchers based on the literature in order to determine the knowledge levels of students on the symptoms, etiology, treatment and nursing care for dementia. (Toye et al., 2014; NICE, 2021; Shaji et al., 2018; Akgün Çıtak, 2016). Students were asked to mark one of the correct, I don't know, incorrect answers for each item. In order to evaluate the test in terms of language, expression, intelligibility, coverage of the subject and whether it contains scientific errors, the opinions of six experts, independent of each other, were taken. The form was rearranged in line with expert opinions.
Measured: for three months
assessment standardized mini mental test
Case Study Form for Individuals Diagnosed with Dementia: The form developed by the researchers consists of four parts for the case study of an individual diagnosed with dementia. In the first part, students were asked to indicate the "Standardized Mini Mental State Test" score for the individual in the case study. In the second part, students were asked to mark one of the statements "I agree", "I am undecided" and "I disagree" for the nursing diagnoses given in accordance with the case. In the third part, they were asked to mark one of the statements "I agree", "I am undecided" or "I disagree" for the nursing interventions specified for the nursing diagnoses of "Lack of self-care", "Risk of trauma" and "Chronic Confusion". In the last section, they were asked to mark one of the statements "I agree", "I am undecided" or "I do not agree" for the items that should be considered when communicating with a person with dementia.
Measured: for three months
determining a nursing diagnosis
Case Study Form for Individuals Diagnosed with Dementia: The form developed by the researchers consists of four parts for the case study of an individual diagnosed with dementia. In the first part, students were asked to indicate the "Standardized Mini Mental State Test" score for the individual in the case study. In the second part, students were asked to mark one of the statements "I agree", "I am undecided" and "I disagree" for the nursing diagnoses given in accordance with the case. In the third part, they were asked to mark one of the statements "I agree", "I am undecided" or "I disagree" for the nursing interventions specified for the nursing diagnoses of "Lack of self-care", "Risk of trauma" and "Chronic Confusion". In the last section, they were asked to mark one of the statements "I agree", "I am undecided" or "I do not agree" for the items that should be considered when communicating with a person with dementia.
Measured: for three months
identifying nursing interventions
Case Study Form for Individuals Diagnosed with Dementia: The form developed by the researchers consists of four parts for the case study of an individual diagnosed with dementia. In the first part, students were asked to indicate the "Standardized Mini Mental State Test" score for the individual in the case study. In the second part, students were asked to mark one of the statements "I agree", "I am undecided" and "I disagree" for the nursing diagnoses given in accordance with the case. In the third part, they were asked to mark one of the statements "I agree", "I am undecided" or "I disagree" for the nursing interventions specified for the nursing diagnoses of "Lack of self-care", "Risk of trauma" and "Chronic Confusion". In the last section, they were asked to mark one of the statements "I agree", "I am undecided" or "I do not agree" for the items that should be considered when communicating with a person with dementia.
Measured: for three months
be able to apply standardized mini mental test
standardized mini mental test: Developed by Folstein et al. (1975), the test provides the grading of cognitive disorders and evaluates cognitive functions in five different parts (orientation, registration, attention and calculation, recall, and language) (Folstein et al., 1975). Turkish validity and reliability were determined by Güngen et al. (2002) by The highest score from the test is 30. Orientation questions are 10 points, recording memory and recall 6 points, attention and calculation 5 points, naming 2 points, repetition 1 point, commands 3 points, reading 1 point, writing 1 point, structuring skill 1 point. A score of less than 24 on the Standardized Mini Mental Test (SMMT) indicates dementia, a score of 24-26 indicates mild neurocognitive impairment, and a score of 26 and above indicates normal cognitive functions. SMMT was found to be a valid and reliable tool in patients with mild dementia in our society.
Measured: during simulation.
Communication Skills
Communication Skills Evaluation Form: It was prepared by researchers in line with the literature on the subject (Jootun \& McGhee, 2011; Akgün Çıtak, 2016; Dikeç \& Kutlu, 2020) in order to objectively evaluate the performance of students regarding communication skills. The form consists of 26 items. The performance of the students, when each step of the student is applied; Evaluated by marking "fully done", "partly done", "did not do"
Measured: during simulation.
Things to consider when contacting
Case Study Form for Individuals Diagnosed with Dementia: The form developed by the researchers consists of four parts for the case study of an individual diagnosed with dementia. In the first part, students were asked to indicate the "Standardized Mini Mental State Test" score for the individual in the case study. In the second part, students were asked to mark one of the statements "I agree", "I am undecided" and "I disagree" for the nursing diagnoses given in accordance with the case. In the third part, they were asked to mark one of the statements "I agree", "I am undecided" or "I disagree" for the nursing interventions specified for the nursing diagnoses of "Lack of self-care", "Risk of trauma" and "Chronic Confusion". In the last section, they were asked to mark one of the statements "I agree", "I am undecided" or "I do not agree" for the items that should be considered when communicating with a person with dementia (Dilek et al., 2017; Akgün Çıtak, 2016).
Measured: for three months
Nursing Diagnosis Detection Skill
Nursing Diagnosis Detection Skill Form: It was prepared with the aim of evaluating students' performance in nursing diagnosis detection skills. Students were asked to write down their nursing diagnoses in accordance with the simulation scenario.
Measured: during simulation.
Students' perceptions of the effectiveness of learning in a simulation environment
Modified-Simulation Efficiency Tool: The measurement tool for students' perceptions of the effectiveness of learning in a simulation environment consists of four sub-dimensions, namely preliminary information, learning, trust and analysis, and nineteen items. The Cronbach Alpha internal consistency coefficient of the measurement tool is 0.92. The items of the scale are scored from 1 to 5 as "Strongly Disagree", "Partly Disagree", "Undecided", "Partly Agree" and "Strongly Agree". "Pre-informing" sub-dimension score range is 2-10, "Learning sub-dimension" score range is 4-25, "Confidence" sub-dimension score range is 7-35, and "Analysis" sub-dimension score range is 5-25. The total score is obtained by summing the scores of all sub-dimensions. The score range is between 18 and 95, and a high score indicates that the student's perception of the effectiveness of learning in the simulation environment is positive.
Measured: during simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start27 May 2021
- Primary completion28 May 2021
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydan Akkurt Yalçıntürk, Saglik Bilimleri Universitesi
- Investigators
- Aydan Akkurt Yalçıntürk, Lecturer, Principal investigator, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246501
- Sponsor's protocol ID
- SY200217B06
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Standardized Patient Simulation Method on Teaching Nursing Students The Skill Of Caring for Individual Diagnosed With Dementia
- ClinicalTrials.gov ID
- NCT05246501
- Acronym / sponsor ID
- SY200217B06
- Conditions
- Dementia, Nursing Caries
- Keywords
- Dementia, patient simulation, nursing education, nursing student, simulation training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 18 Feb 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.
This research is a randomized controlled study conducted to examine the effect of standard patient simulation training in providing nursing students with the ability to care for individuals with dementia.
The population of the research consisted of 100 students who were enrolled in the Nursing Faculty and took the "Psychiatric Nursing" course in 2020-2021 academic year. 84 students who were in the universe and completed the pre-test were randomly assigned to the experimental groups that received simulation training and the control groups that did not receive simulation training. The study was completed with 36 students in the experimental group and 35 students in the control group. Research data were collected with "Personal Coding System and Scale Cover Document", "Structured Student Information Form", "Dementia Information Test", "Case Study Form for Individuals Diagnosed with Dementia", "Standardized Mini Mental Examination", "Communication Skills Evaluation Form", Nursing Diagnosis Detection Skill Form" and "Modified-Simulation Effectiveness Tool".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation | Experimental | Other: Simulation |
| control group | Active comparator | Other: No simulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Registered in Hamidiye Faculty of Nursing,
- Taking a psychiatric nursing course in the spring semester of the 2020-2021 academic year,
- Do not have a communication problem at a level that prevents meeting,
- Students who volunteered to participate in the study were included in the study.
Key exclusion criteria (4 listed)
- Not registered in Hamidiye Nursing Faculty,
- Those who did not take a psychiatric nursing course in the spring semester of the 2020-2021 academic year,
- Having a communication problem at a level that prevents meeting,
- Students who did not volunteer to participate in the study were excluded from the study.
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 |
|---|---|---|
| SimulationA case scenario with a diagnosis of dementia was used in the study. The scenario consisted of preliminary preparation, implementation and evaluation parts. Psychiatric nursing laboratory practice was applied to the students in the scenario study group. An elderly female standard patient who was diagnosed with dementia took part in the scenario. During this simulation, students were expected to perform mental state examination of the patient, use therapeutic communication techniques and ensure environmental safety. | Other | Simulation |
| No simulationThe students in the control group did not receive simulation training. | Other | control group |
Primary outcome
Scale Cover Document with Personal Coding System
Time frame: for three months
Scale Cover Document with Personal Coding System: A rare code was found with the coding of the first letter of the students' mothers' maiden name, the month of birth, the total number of siblings, the number of sisters, the number of brothers
students' introductory characteristics
Time frame: before simulation.
Students were asked to fill in the pretest and posttest. Structured Student Information Form: In this form, which was created by scanning the literature, the age, gender, high school graduated, economic status, the presence of a person diagnosed with dementia in the family, the closeness of the individual diagnosed with dementia, the status and duration of living with the individual with dementia, the status and duration of caring for the individual with dementia. There are 12 questions in total, consisting of self-confidence in caregiving, feeling competent and willing, getting information about dementia, sources of information and the first word that comes to mind when dementia is mentioned (Webster and DiBartolo, 2014; Maharaj, 2017).
Dementia Knowledge
Time frame: for three months
Dementia Knowledge Test: The Dementia Knowledge Test consists of thirty items prepared by the researchers based on the literature in order to determine the knowledge levels of students on the symptoms, etiology, treatment and nursing care for dementia. (Toye et al., 2014; NICE, 2021; Shaji et al., 2018; Akgün Çıtak, 2016). Students were asked to mark one of the correct, I don't know, incorrect answers for each item. In order to evaluate the test in terms of language, expression, intelligibility, coverage of the subject and whether it contains scientific errors, the opinions of six experts, independent of each other, were taken. The form was rearranged in line with expert opinions.
assessment standardized mini mental test
Time frame: for three months
Case Study Form for Individuals Diagnosed with Dementia: The form developed by the researchers consists of four parts for the case study of an individual diagnosed with dementia. In the first part, students were asked to indicate the "Standardized Mini Mental State Test" score for the individual in the case study. In the second part, students were asked to mark one of the statements "I agree", "I am undecided" and "I disagree" for the nursing diagnoses given in accordance with the case. In the third part, they were asked to mark one of the statements "I agree", "I am undecided" or "I disagree" for the nursing interventions specified for the nursing diagnoses of "Lack of self-care", "Risk of trauma" and "Chronic Confusion". In the last section, they were asked to mark one of the statements "I agree", "I am undecided" or "I do not agree" for the items that should be considered when communicating with a person with dementia.
determining a nursing diagnosis
Time frame: for three months
Case Study Form for Individuals Diagnosed with Dementia: The form developed by the researchers consists of four parts for the case study of an individual diagnosed with dementia. In the first part, students were asked to indicate the "Standardized Mini Mental State Test" score for the individual in the case study. In the second part, students were asked to mark one of the statements "I agree", "I am undecided" and "I disagree" for the nursing diagnoses given in accordance with the case. In the third part, they were asked to mark one of the statements "I agree", "I am undecided" or "I disagree" for the nursing interventions specified for the nursing diagnoses of "Lack of self-care", "Risk of trauma" and "Chronic Confusion". In the last section, they were asked to mark one of the statements "I agree", "I am undecided" or "I do not agree" for the items that should be considered when communicating with a person with dementia.
identifying nursing interventions
Time frame: for three months
Case Study Form for Individuals Diagnosed with Dementia: The form developed by the researchers consists of four parts for the case study of an individual diagnosed with dementia. In the first part, students were asked to indicate the "Standardized Mini Mental State Test" score for the individual in the case study. In the second part, students were asked to mark one of the statements "I agree", "I am undecided" and "I disagree" for the nursing diagnoses given in accordance with the case. In the third part, they were asked to mark one of the statements "I agree", "I am undecided" or "I disagree" for the nursing interventions specified for the nursing diagnoses of "Lack of self-care", "Risk of trauma" and "Chronic Confusion". In the last section, they were asked to mark one of the statements "I agree", "I am undecided" or "I do not agree" for the items that should be considered when communicating with a person with dementia.
be able to apply standardized mini mental test
Time frame: during simulation.
standardized mini mental test: Developed by Folstein et al. (1975), the test provides the grading of cognitive disorders and evaluates cognitive functions in five different parts (orientation, registration, attention and calculation, recall, and language) (Folstein et al., 1975). Turkish validity and reliability were determined by Güngen et al. (2002) by The highest score from the test is 30. Orientation questions are 10 points, recording memory and recall 6 points, attention and calculation 5 points, naming 2 points, repetition 1 point, commands 3 points, reading 1 point, writing 1 point, structuring skill 1 point. A score of less than 24 on the Standardized Mini Mental Test (SMMT) indicates dementia, a score of 24-26 indicates mild neurocognitive impairment, and a score of 26 and above indicates normal cognitive functions. SMMT was found to be a valid and reliable tool in patients with mild dementia in our society.
Communication Skills
Time frame: during simulation.
Communication Skills Evaluation Form: It was prepared by researchers in line with the literature on the subject (Jootun \& McGhee, 2011; Akgün Çıtak, 2016; Dikeç \& Kutlu, 2020) in order to objectively evaluate the performance of students regarding communication skills. The form consists of 26 items. The performance of the students, when each step of the student is applied; Evaluated by marking "fully done", "partly done", "did not do"
Things to consider when contacting
Time frame: for three months
Case Study Form for Individuals Diagnosed with Dementia: The form developed by the researchers consists of four parts for the case study of an individual diagnosed with dementia. In the first part, students were asked to indicate the "Standardized Mini Mental State Test" score for the individual in the case study. In the second part, students were asked to mark one of the statements "I agree", "I am undecided" and "I disagree" for the nursing diagnoses given in accordance with the case. In the third part, they were asked to mark one of the statements "I agree", "I am undecided" or "I disagree" for the nursing interventions specified for the nursing diagnoses of "Lack of self-care", "Risk of trauma" and "Chronic Confusion". In the last section, they were asked to mark one of the statements "I agree", "I am undecided" or "I do not agree" for the items that should be considered when communicating with a person with dementia (Dilek et al., 2017; Akgün Çıtak, 2016).
Nursing Diagnosis Detection Skill
Time frame: during simulation.
Nursing Diagnosis Detection Skill Form: It was prepared with the aim of evaluating students' performance in nursing diagnosis detection skills. Students were asked to write down their nursing diagnoses in accordance with the simulation scenario.
Students' perceptions of the effectiveness of learning in a simulation environment
Time frame: during simulation
Modified-Simulation Efficiency Tool: The measurement tool for students' perceptions of the effectiveness of learning in a simulation environment consists of four sub-dimensions, namely preliminary information, learning, trust and analysis, and nineteen items. The Cronbach Alpha internal consistency coefficient of the measurement tool is 0.92. The items of the scale are scored from 1 to 5 as "Strongly Disagree", "Partly Disagree", "Undecided", "Partly Agree" and "Strongly Agree". "Pre-informing" sub-dimension score range is 2-10, "Learning sub-dimension" score range is 4-25, "Confidence" sub-dimension score range is 7-35, and "Analysis" sub-dimension score range is 5-25. The total score is obtained by summing the scores of all sub-dimensions. The score range is between 18 and 95, and a high score indicates that the student's perception of the effectiveness of learning in the simulation environment is positive.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- 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.
Aydan Akkurt Yalçıntürk, Lecturer principal investigator
Saglik Bilimleri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation and No simulation in people with Dementia and Nursing Caries, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 4 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 18 Feb 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 Turkey (Türkiye). 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 Aydan Akkurt Yalçıntürk, Lecturer (05321392497, aydanyalcinturk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale Cover Document with Personal Coding System (time frame: for three months). The study lists 11 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 18 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.