Evidence-Based NursingNCT03411668
EBP Educational Programme in Nursing Students' EBP Beliefs and Knowledge, and the Extent of Their EBP Implementation
A study testing EBP Educational Programme in people with Evidence-Based Nursing, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
Trial summary
Evidence-based practice (EBP) prevents unsafety/inefficiency and improves healthcare quality. However, EBP implementation and sustainment are challenging for healthcare organizations and providers considering gaps between research and practice. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Evidence-Based Nursing
- What is being tested?
- EBP Educational Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 sitePortugal
- Study dates
- 14 Feb 2018to 22 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergraduate nursing students, aged 18 years or older, attending the 8th semester of the degree course in nursing at a nursing school in Portugal
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Evidence Based Practice (EBP) Educational Programme in Undergraduate Nursing Students' EBP Beliefs and Knowledge, and the Extent of Their EBP Implementation: A Cluster Randomized Control Trial
Evidence-based practice (EBP) prevents unsafety/inefficiency and improves healthcare quality. However, EBP implementation and sustainment are challenging for healthcare organizations and providers considering gaps between research and practice. An educational preparation of the future healthcare professionals can minimize these gaps. Thus, it is mandatory that undergraduate curricula in health sciences, namely in nursing, promote an EBP culture so that future health professionals use it into clinical practice. Within the Portuguese context, there is no available scientific literature about the current state of EBP integration in the undergraduate nursing curricula. Thereby, the investigators intend to verify if an EBP educational programme would be successful in improving the undergraduate nursing students' EBP knowledge and beliefs and, and the extent of their EBP implementation This will be tested using a prospective cluster randomized control trial with two-armed parallel group design.
Read the detailed description
Evidence-Based Practice (EBP), also known as Evidence-Informed Practice, could be defined as a "clinical decision-making that considers the best available evidence; the context in which the care is delivered; client preference; and the professional judgment of the health professional".
It has been recognizing that the adoption, implementation and sustainment of EBP in healthcare organizations are very important to promotes high-value health care, improves the patient experience and health outcomes, and reduces health care costs.
In consequence, several organizations acclaim EBP implementation, because this implementation improves the quality of care; reduces the uncertainty, risk and variability; and becomes the decision-making more simplified. Moreover, Dawes et al at the "Sicily statement on evidence-based practice" highlighted that "all health care professionals need to understand the principles of EBP, recognize EBP in action, implement evidence-based policies, and have a critical attitude to their own practice and to evidence".
Nevertheless, nowadays EBP is not the standard of care in the world and some studies recognized education as a strategy to promotes the adoption, implementation and sustainment of EBP.
In fact, the Committee on the Health Professions Education Summit in 2003 recommended the development of competencies regarding the EBP use in all health professional educational programs. Therefore, it is important that undergraduate nursing curricula are based on EBP principles to educate the future nurses to use EBP into clinical practice. This will, consequently, improve health outcomes, with a positive impact in patients' safety, costs and health systems. Regardless of the above recommendation, the nursing curricula still provide contents related to traditional nursing research and do not integrate the EBP content and process.
Therefore, this randomized control trial aims to evaluate the effectiveness of an educational EBP programme in undergraduate nursing students' EBP beliefs and knowledge, and the extent of their EBP implementation. This study will have two arms: experimental group (EBP educational program) and control group (no intervention - education as usual) and it will have the following methodology:
- Sample: For sample size calculation it was used the software G*Power 3.1.9.2. Power analysis was based on a type I error of 0.05; power of 0.80; effect size f=0.25; and ANOVA: repeated measures between factors determined a total sample size of 92. In a Portuguese nursing school, six optional courses of the 8th semester of the nursing graduation were randomly assigned to experimental (EBP educational programme) or control group (no intervention - education as usual). An independent researcher performed this assignment using random.org.
- Intervention: The EBP educational programme will be implemented over 17 weeks (12 hours of lessons - expositive method and practice method and 3 sessions of mentorship to small groups of students - 2/3 students - with the duration of 2 hours each).
- Assessment: All participants will be assessed before (week 0) and after the intervention (week 18) by a blind assessor using the validated instruments to assess undergraduate nursing students' EBP beliefs, the extent of their EBP implementation and their knowledge in EBP.
- Data analysis: The data will be analyzed using Statistical Package for the Social Sciences (SPSS) to conduct a descriptive and inferential analysis. To minimize the noncompliance impact, the intention to treat analysis - Last observation carried forward will be used.
- Conditions
- Evidence-Based Nursing
- Being tested
- EBP Educational Programme
- Keywords
- undergraduate nursing students, evidence based practice beliefs, evidence based practice knowledge, evidence based practice implementation, Evidence based practice Education programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBP Educational ProgrammeOther
The educational EBP programme will include 12 hours of classroom lessons regarding EBP more 6 hours of mentorship made to a small groups of students (2 or 3 students per group).
| Study group | Role | What they receive |
|---|---|---|
| EBP Educational Programme | Experimental | The educational EBP programme will include 12 hours of classroom lessons regarding EBP more 6 hours of mentorship made to a small groups of students (2 or 3 students per group). Receives: Other: EBP Educational Programme |
| Usual Educational Programme | No intervention | Without intervention. The participants in this group will be maintain usual educational programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the participant's Evidence Based Practice knowledge
Outcome measure: "Fresno Test" of Ramos, Schafer, \& Tracz (2003) - adapted to nursing students and Portuguese population
Measured: Post-intervention assessment (week 18)
Secondary outcomes (2)
Change from Baseline in the participant's Evidence Based Practice beliefs
Outcome measure: Evidence Based Practice beliefs scale of Melnyk, Fineout-Overholt, \& Mays (2008) - Portuguese version.
Minimum score: 16; maximum score: 80. Higher values represent a better outcome.
Measured: Post-intervention assessment (week 18)
Change from Baseline in the participant's Evidence Based Practice implementation
Outcome measure: Evidence Based Practice implementation scale for students of Melnyk, Fineout-Overholt, \& Mays (2008) - Portuguese version.
Minimum score: 0; maximum score: 72. Higher values represent a better outcome.
Measured: Post-intervention assessment (week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start14 Feb 2018
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Evidence-Based NursingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Enfermagem de Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Coimbra
- Responsible party
- Principal investigator, Daniela Cardoso, Escola Superior de Enfermagem de Coimbra
- Investigators
- Daniela Cardoso, RN, Principal investigator, UICISA: E, ESEnfC/Faculty of Medicine, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411668
- Sponsor's protocol ID
- EBP_Educ_Nurs
- Status last verified
- Jan 2019
- First submitted
- 20 Jan 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Apostolo J, Cardoso D, Rodrigues MA. It takes three to tango: embracing EBP. JBI Database System Rev Implement Rep. 2016 Apr;14(4):1-2. doi: 10.11124/JBISRIR-2016-2889. No abstract available.
PubMed 27532303Asokan GV. Evidence-based practice curriculum in allied health professions for teaching-research-practice nexus. J Evid Based Med. 2012 Nov;5(4):226-31. doi: 10.1111/jebm.12000.
PubMed 23557503Black AT, Balneaves LG, Garossino C, Puyat JH, Qian H. Promoting evidence-based practice through a research training program for point-of-care clinicians. J Nurs Adm. 2015 Jan;45(1):14-20. doi: 10.1097/NNA.0000000000000151.
PubMed 25390076Institute of Medicine (US) Committee on the Health Professions Education Summit; Greiner AC, Knebel E, editors. Health Professions Education: A Bridge to Quality. Washington (DC): National Academies Press (US); 2003. Available from http://www.ncbi.nlm.nih.gov/books/NBK221528/
PubMed 25057657Dawes M, Summerskill W, Glasziou P, Cartabellotta A, Martin J, Hopayian K, Porzsolt F, Burls A, Osborne J; Second International Conference of Evidence-Based Health Care Teachers and Developers. Sicily statement on evidence-based practice. BMC Med Educ. 2005 Jan 5;5(1):1. doi: 10.1186/1472-6920-5-1.
PubMed 15634359Mazurek Melnyk B, Newhouse R. Evidence-based practice versus evidence-informed practice: a debate that could stall forward momentum in improving healthcare quality, safety, patient outcomes, and costs. Worldviews Evid Based Nurs. 2014 Dec;11(6):347-9. doi: 10.1111/wvn.12070. Epub 2014 Nov 13. No abstract available.
PubMed 25394811Melnyk BM, Fineout-Overholt E, Mays MZ. The evidence-based practice beliefs and implementation scales: psychometric properties of two new instruments. Worldviews Evid Based Nurs. 2008;5(4):208-16. doi: 10.1111/j.1741-6787.2008.00126.x.
PubMed 19076922Melnyk BM, Fineout-Overholt E, Gallagher-Ford L, Kaplan L. The state of evidence-based practice in US nurses: critical implications for nurse leaders and educators. J Nurs Adm. 2012 Sep;42(9):410-7. doi: 10.1097/NNA.0b013e3182664e0a.
PubMed 22922750Melnyk BM, Gallagher-Ford L, Long LE, Fineout-Overholt E. The establishment of evidence-based practice competencies for practicing registered nurses and advanced practice nurses in real-world clinical settings: proficiencies to improve healthcare quality, reliability, patient outcomes, and costs. Worldviews Evid Based Nurs. 2014 Feb;11(1):5-15. doi: 10.1111/wvn.12021. Epub 2014 Jan 21.
PubMed 24447399Oh EG, Kim S, Kim SS, Kim S, Cho EY, Yoo JS, Kim HS, Lee JH, You MA, Lee H. Integrating evidence-based practice into RN-to-BSN clinical nursing education. J Nurs Educ. 2010 Jul;49(7):387-92. doi: 10.3928/01484834-20100331-02. Epub 2010 Mar 31.
PubMed 20411864Ramos KD, Schafer S, Tracz SM. Validation of the Fresno test of competence in evidence based medicine. BMJ. 2003 Feb 8;326(7384):319-21. doi: 10.1136/bmj.326.7384.319.
PubMed 12574047Directorate-General of Health, Ministry of Health. (2012). National Health Plan 2012-2016. Lisbon, Portugal: author. Retrieved from http://pns.dgs.pt/pns-versao-completa/
International Council of Nurses. (2012). Closing the Gap: from Evidence to Action. Geneva: author. ISBN: 978-92-95094-75-8
Ordem dos Enfermeiros. (2006). Tomada de Posição sobre Investigação em Enfermagem. Lisboa: author. Retrieved from http://www.ordemenfermeiros.pt/tomadasposicao/Documents/TomadaPosicao_26Abr2006.pdf
Mohsen, M. M., Safaan, N. A., & Okby, O. M. (2016). Nurses' Perceptions and Barriers for Adoption of Evidence Based Practice in Primary Care: Bridging the Gap. American Journal of Nursing Research, 4(2), 25-33.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Evidence Based Practice (EBP) Educational Programme in Undergraduate Nursing Students' EBP Beliefs and Knowledge, and the Extent of Their EBP Implementation: A Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03411668
- Acronym / sponsor ID
- EBP_Educ_Nurs
- Conditions
- Evidence-Based Nursing
- Keywords
- undergraduate nursing students, evidence based practice beliefs, evidence based practice knowledge, evidence based practice implementation, Evidence based practice Education programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Escola Superior de Enfermagem de CoimbraUniversity, hospital or other
- Collaborators
- University of Coimbra
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 26 Jan 2018 (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.
Evidence-based practice (EBP) prevents unsafety/inefficiency and improves healthcare quality. However, EBP implementation and sustainment are challenging for healthcare organizations and providers considering gaps between research and practice. An educational preparation of the future healthcare professionals can minimize these gaps. Thus, it is mandatory that undergraduate curricula in health sciences, namely in nursing, promote an EBP culture so that future health professionals use it into clinical practice. Within the Portuguese context, there is no available scientific literature about the current state of EBP integration in the undergraduate nursing curricula. Thereby, the investigators intend to verify if an EBP educational programme would be successful in improving the undergraduate nursing students' EBP knowledge and beliefs and, and the extent of their EBP implementation This will be tested using a prospective cluster randomized control trial with two-armed parallel group design.
Detailed description
Evidence-Based Practice (EBP), also known as Evidence-Informed Practice, could be defined as a "clinical decision-making that considers the best available evidence; the context in which the care is delivered; client preference; and the professional judgment of the health professional".
It has been recognizing that the adoption, implementation and sustainment of EBP in healthcare organizations are very important to promotes high-value health care, improves the patient experience and health outcomes, and reduces health care costs.
In consequence, several organizations acclaim EBP implementation, because this implementation improves the quality of care; reduces the uncertainty, risk and variability; and becomes the decision-making more simplified. Moreover, Dawes et al at the "Sicily statement on evidence-based practice" highlighted that "all health care professionals need to understand the principles of EBP, recognize EBP in action, implement evidence-based policies, and have a critical attitude to their own practice and to evidence".
Nevertheless, nowadays EBP is not the standard of care in the world and some studies recognized education as a strategy to promotes the adoption, implementation and sustainment of EBP.
In fact, the Committee on the Health Professions Education Summit in 2003 recommended the development of competencies regarding the EBP use in all health professional educational programs. Therefore, it is important that undergraduate nursing curricula are based on EBP principles to educate the future nurses to use EBP into clinical practice. This will, consequently, improve health outcomes, with a positive impact in patients' safety, costs and health systems. Regardless of the above recommendation, the nursing curricula still provide contents related to traditional nursing research and do not integrate the EBP content and process.
Therefore, this randomized control trial aims to evaluate the effectiveness of an educational EBP programme in undergraduate nursing students' EBP beliefs and knowledge, and the extent of their EBP implementation. This study will have two arms: experimental group (EBP educational program) and control group (no intervention - education as usual) and it will have the following methodology:
- Sample: For sample size calculation it was used the software G*Power 3.1.9.2. Power analysis was based on a type I error of 0.05; power of 0.80; effect size f=0.25; and ANOVA: repeated measures between factors determined a total sample size of 92. In a Portuguese nursing school, six optional courses of the 8th semester of the nursing graduation were randomly assigned to experimental (EBP educational programme) or control group (no intervention - education as usual). An independent researcher performed this assignment using random.org.
- Intervention: The EBP educational programme will be implemented over 17 weeks (12 hours of lessons - expositive method and practice method and 3 sessions of mentorship to small groups of students - 2/3 students - with the duration of 2 hours each).
- Assessment: All participants will be assessed before (week 0) and after the intervention (week 18) by a blind assessor using the validated instruments to assess undergraduate nursing students' EBP beliefs, the extent of their EBP implementation and their knowledge in EBP.
- Data analysis: The data will be analyzed using Statistical Package for the Social Sciences (SPSS) to conduct a descriptive and inferential analysis. To minimize the noncompliance impact, the intention to treat analysis - Last observation carried forward will be used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBP Educational Programme | Experimental | Other: EBP Educational ProgrammeThe educational EBP programme will include 12 hours of classroom lessons regarding EBP more 6 hours of mentorship made to a small groups of students (2 or 3 students per group). |
| Usual Educational Programme | No intervention | –Without intervention. The participants in this group will be maintain usual educational programme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergraduate nursing students, aged 18 years or older, attending the 8th semester of the degree course in nursing at a nursing school in Portugal
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| EBP Educational ProgrammeThe educational EBP programme will include 12 hours of classroom lessons regarding EBP more 6 hours of mentorship made to a small groups of students (2 or 3 students per group). | Other | EBP Educational Programme |
Primary outcome
Change from Baseline in the participant's Evidence Based Practice knowledge
Time frame: Post-intervention assessment (week 18)
Outcome measure: "Fresno Test" of Ramos, Schafer, \& Tracz (2003) - adapted to nursing students and Portuguese population
2 secondary outcomes
Change from Baseline in the participant's Evidence Based Practice beliefs
Time frame: Post-intervention assessment (week 18)
Change from Baseline in the participant's Evidence Based Practice implementation
Time frame: Post-intervention assessment (week 18)
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 23 Jan 2019.
- Background: PubMed 27532303Apostolo J, Cardoso D, Rodrigues MA. It takes three to tango: embracing EBP. JBI Database System Rev Implement Rep. 2016 Apr;14(4):1-2. doi: 10.11124/JBISRIR-2016-2889. No abstract available.
- Background: PubMed 23557503Asokan GV. Evidence-based practice curriculum in allied health professions for teaching-research-practice nexus. J Evid Based Med. 2012 Nov;5(4):226-31. doi: 10.1111/jebm.12000.
- Background: PubMed 25390076Black AT, Balneaves LG, Garossino C, Puyat JH, Qian H. Promoting evidence-based practice through a research training program for point-of-care clinicians. J Nurs Adm. 2015 Jan;45(1):14-20. doi: 10.1097/NNA.0000000000000151.
- Background: PubMed 25057657Institute of Medicine (US) Committee on the Health Professions Education Summit; Greiner AC, Knebel E, editors. Health Professions Education: A Bridge to Quality. Washington (DC): National Academies Press (US); 2003. Available from http://www.ncbi.nlm.nih.gov/books/NBK221528/
- Background: PubMed 15634359Dawes M, Summerskill W, Glasziou P, Cartabellotta A, Martin J, Hopayian K, Porzsolt F, Burls A, Osborne J; Second International Conference of Evidence-Based Health Care Teachers and Developers. Sicily statement on evidence-based practice. BMC Med Educ. 2005 Jan 5;5(1):1. doi: 10.1186/1472-6920-5-1.
- Background: PubMed 25394811Mazurek Melnyk B, Newhouse R. Evidence-based practice versus evidence-informed practice: a debate that could stall forward momentum in improving healthcare quality, safety, patient outcomes, and costs. Worldviews Evid Based Nurs. 2014 Dec;11(6):347-9. doi: 10.1111/wvn.12070. Epub 2014 Nov 13. No abstract available.
- Background: PubMed 19076922Melnyk BM, Fineout-Overholt E, Mays MZ. The evidence-based practice beliefs and implementation scales: psychometric properties of two new instruments. Worldviews Evid Based Nurs. 2008;5(4):208-16. doi: 10.1111/j.1741-6787.2008.00126.x.
- Background: PubMed 22922750Melnyk BM, Fineout-Overholt E, Gallagher-Ford L, Kaplan L. The state of evidence-based practice in US nurses: critical implications for nurse leaders and educators. J Nurs Adm. 2012 Sep;42(9):410-7. doi: 10.1097/NNA.0b013e3182664e0a.
- Background: PubMed 24447399Melnyk BM, Gallagher-Ford L, Long LE, Fineout-Overholt E. The establishment of evidence-based practice competencies for practicing registered nurses and advanced practice nurses in real-world clinical settings: proficiencies to improve healthcare quality, reliability, patient outcomes, and costs. Worldviews Evid Based Nurs. 2014 Feb;11(1):5-15. doi: 10.1111/wvn.12021. Epub 2014 Jan 21.
- Background: PubMed 20411864Oh EG, Kim S, Kim SS, Kim S, Cho EY, Yoo JS, Kim HS, Lee JH, You MA, Lee H. Integrating evidence-based practice into RN-to-BSN clinical nursing education. J Nurs Educ. 2010 Jul;49(7):387-92. doi: 10.3928/01484834-20100331-02. Epub 2010 Mar 31.
- Background: PubMed 12574047Ramos KD, Schafer S, Tracz SM. Validation of the Fresno test of competence in evidence based medicine. BMJ. 2003 Feb 8;326(7384):319-21. doi: 10.1136/bmj.326.7384.319.
- BackgroundDirectorate-General of Health, Ministry of Health. (2012). National Health Plan 2012-2016. Lisbon, Portugal: author. Retrieved from http://pns.dgs.pt/pns-versao-completa/
- Individual participant dataSharing planned: Undecided
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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.
Daniela Cardoso, RN principal investigator
UICISA: E, ESEnfC/Faculty of Medicine, University of Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBP Educational Programme in people with Evidence-Based Nursing, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
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 1 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 23 Jan 2019. 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 Portugal. 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 in the participant's Evidence Based Practice knowledge (time frame: Post-intervention assessment (week 18)). 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 NCT03411668, which also lists 16 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 23 Jan 2019.