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/NCT06003803</url>
    </required_header>
    <id_info>
      <org_study_id>digital learning</org_study_id>
      <nct_id>NCT06003803</nct_id>
    </id_info>
    <brief_title>Digital Learning on Competence in Motivational Interviewing</brief_title>
    <official_title>Effects of Self-Regulated Digital Learning on Competence in Motivational Interviewing on Patients' Medication Adherence Among Psychiatric Mental Health Nurses</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taipei University of Nursing and Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taipei University of Nursing and Health Sciences</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>
        Motivational interviewing is an essential practical skill to promote medication adherence;&#xD;
        however, it is rarely emphasised in nursing education. Purposes: 1. To develop a&#xD;
        self-regulated digital learning system for motivational interviewing; 2. To evaluate the&#xD;
        effectiveness of digital learning of motivational interviewing on mental health nurses'&#xD;
        knowledge, skills and self-efficacy; 3. To compare the effectiveness of self-regulated&#xD;
        digital learning, blended learning and treatment as usual learning.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 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>Treatment</primary_purpose>
      <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>motivational interviewing skill</measure>
      <time_frame>The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]</time_frame>
      <description>Motivational Interviewing skill is a 12-items assessment tool.Total scores is range between 0 and 12, with a higher score indicating better skill.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Motivational Interviewing Knowledge and Attitudes Test (MIKAT)</measure>
      <time_frame>The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]</time_frame>
      <description>Motivational Interviewing Knowledge and Attitudes Test is a 29-items self-reporting scales.Total scores on the MIKAT range between 0 and 29, with a higher score indicating better knowledge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motivational Interviewing Confidence Survey (MICS)</measure>
      <time_frame>The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]</time_frame>
      <description>MICS is a 24-items self-reporting with 10-point Likert scale.Total scores on the MICS range between 0 and 240, with a higher score indicating better self-efficacy.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>self-regulation scale for Taiwanese college students (TSSRQ)</measure>
      <time_frame>The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]</time_frame>
      <description>TSSRQ is a 39-items self-reporting with a higher score indicating better self-regulation.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">118</enrollment>
    <condition>Nurse's Role</condition>
    <condition>Motivation</condition>
    <arm_group>
      <arm_group_label>digital learning in motivational interviewing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Receive digital learning in motivational interviewing for three months, once a week, 40 minutes each time</description>
    </arm_group>
    <arm_group>
      <arm_group_label>conventional education</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Receive conventional education for three months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>digital learning in motivational interviewing</intervention_name>
      <description>Receive digital learning in motivational interviewing for three months, once a week, 40 minutes each time</description>
      <arm_group_label>digital learning in motivational interviewing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  psychiatric registered nurse&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  nursing administrator&#xD;
  &#xD;
            -  expected to resign within three months&#xD;
  &#xD;
            -  blended learners who have participated in motivational interviewing&#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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Taipei University of Nursing and Health Sciences</investigator_affiliation>
      <investigator_full_name>Wen I Liu</investigator_full_name>
      <investigator_title>Distinguished Professor</investigator_title>
    </responsible_party>
    <keyword>digital learning</keyword>
    <keyword>motivational interviewing</keyword>
    <keyword>self-regulation</keyword>
    <!-- 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/NCT06003803
  org study id: digital learning
  nct id: NCT06003803
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Motivational interviewing is an essential practical skill to promote medication adherence;
        however, it is rarely emphasised in nursing education. Purposes: 1. To develop a
        self-regulated digital learning system for motivational interviewing; 2. To evaluate the
        effectiveness of digital learning of motivational interviewing on mental health nurses'
        knowledge, skills and self-efficacy; 3. To compare the effectiveness of self-regulated
        digital learning, blended learning and treatment as usual learning.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  measure: motivational interviewing skill
  time frame: The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]
  description: Motivational Interviewing skill is a 12-items assessment tool.Total scores is range between 0 and 12, with a higher score indicating better skill.
  measure: Motivational Interviewing Knowledge and Attitudes Test (MIKAT)
  time frame: The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]
  description: Motivational Interviewing Knowledge and Attitudes Test is a 29-items self-reporting scales.Total scores on the MIKAT range between 0 and 29, with a higher score indicating better knowledge.
  measure: Motivational Interviewing Confidence Survey (MICS)
  time frame: The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]
  description: MICS is a 24-items self-reporting with 10-point Likert scale.Total scores on the MICS range between 0 and 240, with a higher score indicating better self-efficacy.
  measure: self-regulation scale for Taiwanese college students (TSSRQ)
  time frame: The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]
  description: TSSRQ is a 39-items self-reporting with a higher score indicating better self-regulation.
  arm group label: digital learning in motivational interviewing
  arm group type: Experimental
  description: Receive digital learning in motivational interviewing for three months, once a week, 40 minutes each time
  arm group label: conventional education
  arm group type: No Intervention
  description: Receive conventional education for three months.
  intervention type: Behavioral
  intervention name: digital learning in motivational interviewing
  description: Receive digital learning in motivational interviewing for three months, once a week, 40 minutes each time
  arm group label: digital learning in motivational interviewing
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: National Taipei University of Nursing and Health Sciences
  investigator full name: Wen I Liu
  investigator title: Distinguished Professor