xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015984</url>
    </required_header>
    <id_info>
      <org_study_id>EBK-01</org_study_id>
      <nct_id>NCT06015984</nct_id>
    </id_info>
    <brief_title>Renal Transplantation Nurse Training on Patient-Centered Care Competence and Counseling Skills</brief_title>
    <official_title>The Effect of Web-Based Renal Transplantation Nurse Training on Patient-Centered Care Competence and Counseling Skills</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Gedik University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Gedik University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        There are two main treatments for end-stage renal disease (ESRD): dialysis and&#xD;
        transplantation.Renal transplantation is the best and most preferred treatment for ESRD&#xD;
        patients.Self management after renal transplantation is difficult. Individuals need&#xD;
        appropriate care,education, counseling and support in order to change their behavior to cope&#xD;
        with health problems during the transplantation process.The aim of nursing care and education&#xD;
        is to enable the individual to acquire the knowledge, skills and attitude to independently&#xD;
        carry out daily life activities and to adopt this as a lifestyle.Nursing care and education&#xD;
        requires an interdisciplinary teamwork, and in this process, the nurse plays a key role as&#xD;
        she constantly interacts with the donor, recipient and family.The research was designed as a&#xD;
        randomized controlled experimental study with pretest-posttest design.A total of 60 nurses,&#xD;
        30 in the control group and 30 in the intervention group,who met the criteria for inclusion&#xD;
        in the study, will form the sample of the study.After obtaining consent from the nurses in&#xD;
        the intervention and control groups, they will be asked to fill out the Nurse&#xD;
        InformationForm, the Patient-Centered Care Competency Scale and the Nurses Counseling Skills&#xD;
        Scale. Aftercompleting the web-based training, intervention group nurses will be asked to&#xD;
        fill in the Patient Centered Care Competency Scale and the Counseling Skills in Nurses Scale&#xD;
        at the 1st and 3rd months. No training will be given to the nurses in the control group and&#xD;
        they will be asked to fill the Patient-Centered Care Competency Scale and the Counseling&#xD;
        Skills for Nurses Scale again.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There are two main treatments for end-stage renal disease (ESRD): dialysis and&#xD;
        transplantation. Renal transplantation (RTx) is the best and most preferred treatment for&#xD;
        ESRD patients. A successful RTx, made from a living or cadaver donor, improves the quality of&#xD;
        life compared to dialysis and fully fulfills the function of the kidney.Self-management after&#xD;
        renal transplantation is difficult. Individuals need appropriate care, education, counseling&#xD;
        and support in order to change their behavior to cope with health problems during the&#xD;
        transplantation process. The aim of nursing care and education is to enable the individual to&#xD;
        acquire the knowledge, skills and attitude to independently carry out daily life activities&#xD;
        and to adopt this as a lifestyle. Nursing care and education requires an interdisciplinary&#xD;
        teamwork, and in this process, the nurse plays a key role as she constantly interacts with&#xD;
        the donor, recipient and family.Today, technology-based methods are used to increase&#xD;
        compliance with transplantation and are increasingly seen as valuable tools. The aim of this&#xD;
        research is to develop and implement a web-based nurse training program for renal&#xD;
        transplantation nurses and to examine the effect of this training on nurses' patient-centered&#xD;
        care competence and counseling skills. The research was designed as a randomized controlled&#xD;
        experimental study with pretest-posttest design.&#xD;
  &#xD;
        The population of the research will be 1870 nurses registered to the Turkish Nephrology,&#xD;
        Dialysis and Transplantation Nurses Association. A total of 60 nurses, 30 in the control&#xD;
        group and 30 in the intervention group, who met the criteria for inclusion in the study, will&#xD;
        form the sample of the study.The research will be carried out on the website&#xD;
        www.bobreknakliokulu.com, which will be developed after a preliminary interview with the&#xD;
        nurses working in the renal transplantation clinics between April and August 2023, and they&#xD;
        will be included in the web-based training as self-managed and asynchronous for 8 weeks.After&#xD;
        obtaining consent from the nurses in the intervention and control groups, they will be asked&#xD;
        to fill out the Nurse Information Form, the Patient-Centered Care Competency Scale and the&#xD;
        Nurses Counseling Skills Scale. After completing the web-based training, intervention group&#xD;
        nurses will be asked to fill in the Patient-Centered Care Competency Scale and the Counseling&#xD;
        Skills in Nurses Scale at the 1st and 3rd months. No training will be given to the nurses in&#xD;
        the control group and they will be asked to fill the Patient-Centered Care Competency Scale&#xD;
        and the Counseling Skills for Nurses Scale again.It is expected that the renal&#xD;
        transplantation nurses who receive this training will contribute positively to the increase&#xD;
        of evidence-based knowledge and the development of clinical practices, the competence of&#xD;
        patient-centered care and the management of counseling skills in line with clinical&#xD;
        guidelines.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient-Centered Care Competency Scale</measure>
      <time_frame>3 months</time_frame>
      <description>Scale, by Hwang (2015); It was developed in order to determine the competencies of nurses in patient-centered care. The Turkish validity and reliability of the scale was made by Arslanoğlu and Kırılmaz (2019). The Cronbach Alpha coefficient is 0.850. Patient-centered care competence consists of 17 questions and 4 sub-dimensions. Sub-dimensions; respecting the point of view (perspective) of patients (item 1-6), encouraging patient participation in care processes (items 7 and 11), ensuring patient comfort (items 12 and 14), and defending the rights of patients (15. - Article 17). Scale; It was designed as a 5-point Likert scale: 1-Strongly Disagree, 2-Disagree, 3-Undecided, 4-Agree, 5-Strongly Agree.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Counseling Skills Scale for Nurses</measure>
      <time_frame>3 months</time_frame>
      <description>After the item pool created by Avcı and Kumcagiz in 2019 was finalized, it was applied to 204 nurses for explanatory factor analysis. The scale consists of 10 items and is a single factor. Afterwards, confirmatory factor analysis (CFA) was performed on 200 nurses. With confirmatory factor analysis, the fit index values of the single factor structure were found to be within acceptable limits (χ2=94,785, sd=33, χ2/sd= 2.872, RMSEA=0.097, GFI=0.92, AGFI=0.86, CFI=0.92 and IFI=0.92) . The validity of the scale was examined by performing EFA and CFA. The reliability of the scale was examined with Cronbach's alpha coefficient and Split-half. Cronbach alpha was calculated as 0.88 and Split-half as 0.86.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Kidney Transplantation</condition>
    <condition>Nursing</condition>
    <condition>Education</condition>
    <condition>Care</condition>
    <condition>Counseling</condition>
    <arm_group>
      <arm_group_label>Web-Based 8-week Asynchronous Renal Transplantation Nurse Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1. Week: application of pre-tests&#xD;
  1. Month: administration of post-tests 3. Month: administration of post-tests</description>
    </arm_group>
    <arm_group>
      <arm_group_label>non-trained nurse group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>1. Week: application of pre-tests&#xD;
  1. Month: administration of post-tests 3. Month: administration of post-tests</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Traning</intervention_name>
      <description>In order to participate in the training module, a user name and password will be given to the initiative group, the link to be used in the self-managed and asynchronous training platform will be shared, and it will be ensured that it participates in the web-based nurse training, and the training will last for eight weeks.</description>
      <arm_group_label>Web-Based 8-week Asynchronous Renal Transplantation Nurse Training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having a maximum of 3 years of working experience in the Renal Transplantation clinic&#xD;
  &#xD;
            -  Having a bachelor's degree in nursing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Nurses not completing all web-based nursing education modules&#xD;
  &#xD;
            -  It will be caused by nurses not completing the 20-minute website usage period&#xD;
               determined for each training module.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emek Bakanoğlu Kalkavan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istanbul Gedik University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emek Bakanoğlu Kalkavan</last_name>
      <phone>05447683055</phone>
      <email>emekkalkavan@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Merdiye Şendir</last_name>
      <phone>05304585737</phone>
      <email>merdiye.sendir@sbu.edu.tr</email>
    </overall_contact_backup>
    <reference>
      <citation>Chiaranai C. The Lived Experience of Patients Receiving Hemodialysis Treatment for End-Stage Renal Disease: A Qualitative Study. J Nurs Res. 2016 Jun;24(2):101-8. doi: 10.1097/jnr.0000000000000100.</citation>
      <PMID>26275156</PMID>
    </reference>
    <reference>
      <citation>Samarehfekri A, Dehghan M, Arab M, Ebadzadeh MR. Effect of Foot Reflexology on Pain, Fatigue, and Quality of Sleep after Kidney Transplantation Surgery: A Parallel Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Aug 1;2020:5095071. doi: 10.1155/2020/5095071. eCollection 2020.</citation>
      <PMID>32831868</PMID>
    </reference>
    <reference>
      <citation>Mathes T, Grosspietsch K, Neugebauer EAM, Pieper D. Interventions to increase adherence in patients taking immunosuppressive drugs after kidney transplantation: a systematic review of controlled trials. Syst Rev. 2017 Nov 29;6(1):236. doi: 10.1186/s13643-017-0633-1.</citation>
      <PMID>29187249</PMID>
    </reference>
    <reference>
      <citation>Kleber J, Cohen B. Reducing Waste and Increasing Sustainability in Health Care Settings. Am J Nurs. 2020 Apr;120(4):45-48. doi: 10.1097/01.NAJ.0000660032.02514.ec.</citation>
      <PMID>32218047</PMID>
    </reference>
    <reference>
      <citation>Kohler B, Kellerer C, Schultz K, Wittmann M, Atmann O, Linde K, Hapfelmeier A, Schneider A. An Internet-Based Asthma Self-Management Program Increases Knowledge About Asthma. Dtsch Arztebl Int. 2020;117(5):64-71. doi: 10.3238/arztebl.2020.0064.</citation>
      <PMID>32070472</PMID>
    </reference>
    <reference>
      <citation>Coresh J, Hu JR, Bello AK, Feldman HI, Fogo AB, Ganji MR, Harris DC, Levey AS, Okpechi IG, Stengel B, Thomas B, Wiecek A, Gansevoort RT. Action plan for determining and monitoring the prevalence of chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):63-70. doi: 10.1016/j.kisu.2017.07.002. Epub 2017 Sep 20.</citation>
      <PMID>30675421</PMID>
    </reference>
    <reference>
      <citation>Chisholm-Burns M, Pinsky B, Parker G, Johnson P, Arcona S, Buzinec P, Chakravarti P, Good M, Cooper M. Factors related to immunosuppressant medication adherence in renal transplant recipients. Clin Transplant. 2012 Sep-Oct;26(5):706-13. doi: 10.1111/j.1399-0012.2011.01589.x. Epub 2012 Feb 10.</citation>
      <PMID>22324912</PMID>
    </reference>
    <reference>
      <citation>Zala P, Schmid-Mohler G. Patients' Experiences of a Nurse-Led Self-Management Intervention After Kidney Transplantation. Nephrol Nurs J. 2022 Jan-Feb;49(1):45-57.</citation>
      <PMID>35225495</PMID>
    </reference>
    <reference>
      <citation>Horka K. Optimizing Care in Kidney Transplantation. Crit Care Nurs Clin North Am. 2022 Dec;34(4):443-451. doi: 10.1016/j.cnc.2022.08.003. Epub 2022 Oct 12.</citation>
      <PMID>36336434</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015984
  org study id: EBK-01
  nct id: NCT06015984
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There are two main treatments for end-stage renal disease (ESRD): dialysis and
        transplantation.Renal transplantation is the best and most preferred treatment for ESRD
        patients.Self management after renal transplantation is difficult. Individuals need
        appropriate care,education, counseling and support in order to change their behavior to cope
        with health problems during the transplantation process.The aim of nursing care and education
        is to enable the individual to acquire the knowledge, skills and attitude to independently
        carry out daily life activities and to adopt this as a lifestyle.Nursing care and education
        requires an interdisciplinary teamwork, and in this process, the nurse plays a key role as
        she constantly interacts with the donor, recipient and family.The research was designed as a
        randomized controlled experimental study with pretest-posttest design.A total of 60 nurses,
        30 in the control group and 30 in the intervention group,who met the criteria for inclusion
        in the study, will form the sample of the study.After obtaining consent from the nurses in
        the intervention and control groups, they will be asked to fill out the Nurse
        InformationForm, the Patient-Centered Care Competency Scale and the Nurses Counseling Skills
        Scale. Aftercompleting the web-based training, intervention group nurses will be asked to
        fill in the Patient Centered Care Competency Scale and the Counseling Skills in Nurses Scale
        at the 1st and 3rd months. No training will be given to the nurses in the control group and
        they will be asked to fill the Patient-Centered Care Competency Scale and the Counseling
        Skills for Nurses Scale again.
  There are two main treatments for end-stage renal disease (ESRD): dialysis and
        transplantation. Renal transplantation (RTx) is the best and most preferred treatment for
        ESRD patients. A successful RTx, made from a living or cadaver donor, improves the quality of
        life compared to dialysis and fully fulfills the function of the kidney.Self-management after
        renal transplantation is difficult. Individuals need appropriate care, education, counseling
        and support in order to change their behavior to cope with health problems during the
        transplantation process. The aim of nursing care and education is to enable the individual to
        acquire the knowledge, skills and attitude to independently carry out daily life activities
        and to adopt this as a lifestyle. Nursing care and education requires an interdisciplinary
        teamwork, and in this process, the nurse plays a key role as she constantly interacts with
        the donor, recipient and family.Today, technology-based methods are used to increase
        compliance with transplantation and are increasingly seen as valuable tools. The aim of this
        research is to develop and implement a web-based nurse training program for renal
        transplantation nurses and to examine the effect of this training on nurses' patient-centered
        care competence and counseling skills. The research was designed as a randomized controlled
        experimental study with pretest-posttest design.
  
        The population of the research will be 1870 nurses registered to the Turkish Nephrology,
        Dialysis and Transplantation Nurses Association. A total of 60 nurses, 30 in the control
        group and 30 in the intervention group, who met the criteria for inclusion in the study, will
        form the sample of the study.The research will be carried out on the website
        www.bobreknakliokulu.com, which will be developed after a preliminary interview with the
        nurses working in the renal transplantation clinics between April and August 2023, and they
        will be included in the web-based training as self-managed and asynchronous for 8 weeks.After
        obtaining consent from the nurses in the intervention and control groups, they will be asked
        to fill out the Nurse Information Form, the Patient-Centered Care Competency Scale and the
        Nurses Counseling Skills Scale. After completing the web-based training, intervention group
        nurses will be asked to fill in the Patient-Centered Care Competency Scale and the Counseling
        Skills in Nurses Scale at the 1st and 3rd months. No training will be given to the nurses in
        the control group and they will be asked to fill the Patient-Centered Care Competency Scale
        and the Counseling Skills for Nurses Scale again.It is expected that the renal
        transplantation nurses who receive this training will contribute positively to the increase
        of evidence-based knowledge and the development of clinical practices, the competence of
        patient-centered care and the management of counseling skills in line with clinical
        guidelines.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Care Provider)
  measure: Patient-Centered Care Competency Scale
  time frame: 3 months
  description: Scale, by Hwang (2015); It was developed in order to determine the competencies of nurses in patient-centered care. The Turkish validity and reliability of the scale was made by Arslanoğlu and Kırılmaz (2019). The Cronbach Alpha coefficient is 0.850. Patient-centered care competence consists of 17 questions and 4 sub-dimensions. Sub-dimensions; respecting the point of view (perspective) of patients (item 1-6), encouraging patient participation in care processes (items 7 and 11), ensuring patient comfort (items 12 and 14), and defending the rights of patients (15. - Article 17). Scale; It was designed as a 5-point Likert scale: 1-Strongly Disagree, 2-Disagree, 3-Undecided, 4-Agree, 5-Strongly Agree.
  measure: Counseling Skills Scale for Nurses
  time frame: 3 months
  description: After the item pool created by Avcı and Kumcagiz in 2019 was finalized, it was applied to 204 nurses for explanatory factor analysis. The scale consists of 10 items and is a single factor. Afterwards, confirmatory factor analysis (CFA) was performed on 200 nurses. With confirmatory factor analysis, the fit index values of the single factor structure were found to be within acceptable limits (χ2=94,785, sd=33, χ2/sd= 2.872, RMSEA=0.097, GFI=0.92, AGFI=0.86, CFI=0.92 and IFI=0.92) . The validity of the scale was examined by performing EFA and CFA. The reliability of the scale was examined with Cronbach's alpha coefficient and Split-half. Cronbach alpha was calculated as 0.88 and Split-half as 0.86.
  arm group label: Web-Based 8-week Asynchronous Renal Transplantation Nurse Training
  arm group type: Experimental
  description: 1. Week: application of pre-tests
  1. Month: administration of post-tests 3. Month: administration of post-tests
  arm group label: non-trained nurse group
  arm group type: No Intervention
  description: 1. Week: application of pre-tests
  1. Month: administration of post-tests 3. Month: administration of post-tests
  intervention type: Behavioral
  intervention name: Traning
  description: In order to participate in the training module, a user name and password will be given to the initiative group, the link to be used in the self-managed and asynchronous training platform will be shared, and it will be ensured that it participates in the web-based nurse training, and the training will last for eight weeks.
  arm group label: Web-Based 8-week Asynchronous Renal Transplantation Nurse Training
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Emek Bakanoğlu Kalkavan
  role: Principal Investigator
  affiliation: Istanbul Gedik University
  last name: Emek Bakanoğlu Kalkavan
  phone: 05447683055
  email: emekkalkavan@gmail.com
  last name: Merdiye Şendir
  phone: 05304585737
  email: merdiye.sendir@sbu.edu.tr
  citation: Chiaranai C. The Lived Experience of Patients Receiving Hemodialysis Treatment for End-Stage Renal Disease: A Qualitative Study. J Nurs Res. 2016 Jun;24(2):101-8. doi: 10.1097/jnr.0000000000000100.
  PMID: 26275156
  citation: Samarehfekri A, Dehghan M, Arab M, Ebadzadeh MR. Effect of Foot Reflexology on Pain, Fatigue, and Quality of Sleep after Kidney Transplantation Surgery: A Parallel Randomized Controlled Trial. Evid Based Complement Alternat Med. 2020 Aug 1;2020:5095071. doi: 10.1155/2020/5095071. eCollection 2020.
  PMID: 32831868
  citation: Mathes T, Grosspietsch K, Neugebauer EAM, Pieper D. Interventions to increase adherence in patients taking immunosuppressive drugs after kidney transplantation: a systematic review of controlled trials. Syst Rev. 2017 Nov 29;6(1):236. doi: 10.1186/s13643-017-0633-1.
  PMID: 29187249
  citation: Kleber J, Cohen B. Reducing Waste and Increasing Sustainability in Health Care Settings. Am J Nurs. 2020 Apr;120(4):45-48. doi: 10.1097/01.NAJ.0000660032.02514.ec.
  PMID: 32218047
  citation: Kohler B, Kellerer C, Schultz K, Wittmann M, Atmann O, Linde K, Hapfelmeier A, Schneider A. An Internet-Based Asthma Self-Management Program Increases Knowledge About Asthma. Dtsch Arztebl Int. 2020;117(5):64-71. doi: 10.3238/arztebl.2020.0064.
  PMID: 32070472
  citation: Coresh J, Hu JR, Bello AK, Feldman HI, Fogo AB, Ganji MR, Harris DC, Levey AS, Okpechi IG, Stengel B, Thomas B, Wiecek A, Gansevoort RT. Action plan for determining and monitoring the prevalence of chronic kidney disease. Kidney Int Suppl (2011). 2017 Oct;7(2):63-70. doi: 10.1016/j.kisu.2017.07.002. Epub 2017 Sep 20.
  PMID: 30675421
  citation: Chisholm-Burns M, Pinsky B, Parker G, Johnson P, Arcona S, Buzinec P, Chakravarti P, Good M, Cooper M. Factors related to immunosuppressant medication adherence in renal transplant recipients. Clin Transplant. 2012 Sep-Oct;26(5):706-13. doi: 10.1111/j.1399-0012.2011.01589.x. Epub 2012 Feb 10.
  PMID: 22324912
  citation: Zala P, Schmid-Mohler G. Patients' Experiences of a Nurse-Led Self-Management Intervention After Kidney Transplantation. Nephrol Nurs J. 2022 Jan-Feb;49(1):45-57.
  PMID: 35225495
  citation: Horka K. Optimizing Care in Kidney Transplantation. Crit Care Nurs Clin North Am. 2022 Dec;34(4):443-451. doi: 10.1016/j.cnc.2022.08.003. Epub 2022 Oct 12.
  PMID: 36336434
  responsible party type: Sponsor
  sharing ipd: No