<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/NCT03804489</url>
  </required_header>
  <id_info>
    <org_study_id>108HHC-03</org_study_id>
    <nct_id>NCT03804489</nct_id>
  </id_info>
  <brief_title>Using &quot;Decision Aids&quot; to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine</brief_title>
  <official_title>Using &quot;Decision Aids&quot; to Help the Infant Family to Decide Whether the Baby Will Receive the Self-paid Oral Rotavirus Vaccine: A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University Shuang Ho Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University Shuang Ho Hospital</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>
      Using decision aids (DA) is one way to provide information to infant family and to involve&#xD;
      them in making decisions about their baby's vaccination. We developed a DA administered after&#xD;
      consultation for baby's family deciding on whether the baby will receive the self-paid oral&#xD;
      rotavirus vaccine&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Acute gastroenteritis is one of the most common infectious diseases and still a major cause&#xD;
      of pediatric morbidity and mortality worldwide. Rotavirus was still the major cause of acute&#xD;
      gastroenteritis in infants and young children worldwide, including in Taiwan. The World&#xD;
      Health Organization has recommended rotavirus vaccine, which became available in 2006, for&#xD;
      all countries. However, not all of children in Taiwan received rotavirus vaccination. Using&#xD;
      decision aids (DA) is one way to provide information to infant family and to involve them in&#xD;
      making decisions about their baby's vaccination. We developed a DA administered after&#xD;
      consultation for baby's family deciding on whether the baby will receive the self-paid oral&#xD;
      rotavirus vaccine Patients and Methods Decision aids are interventions designed to help&#xD;
      infant family make choices among options by providing information relevant to oral rotavirus&#xD;
      vaccine. Infant coming to receiving regular routine vaccination at 1 month old are randomly&#xD;
      assigned to receive a DA or the standard oral conversation (control condition) after the&#xD;
      initial consultation. Infant family complete interview-based questionnaires 1 month later&#xD;
      when they came back to hospital receiving 2-month-old regular routine vaccination and decide&#xD;
      to receive self-paid oral rotavirus vaccine or not at that time. Primary outcome measures:&#xD;
      decisional conflict and decision-making difficulties at 2-month-old.&#xD;
&#xD;
      Results and Conclusion The DA group are predicted to lower decisional conflict scores when&#xD;
      compared with the control group. Our study hopes to support the efficacy of DA in helping the&#xD;
      infant family to decide whether the baby will receive the self-paid oral rotavirus vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 25, 2019</start_date>
  <completion_date type="Anticipated">December 25, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 25, 2019</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>
    <intervention_model_description>Decision aids</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decisional conflict</measure>
    <time_frame>An average of 1 month after intervention</time_frame>
    <description>Total score of decisional conflict scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decision-making difficulties</measure>
    <time_frame>An average of 1 month after intervention</time_frame>
    <description>Total score of decision-making scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Rotavirus Vaccines</condition>
  <arm_group>
    <arm_group_label>Decision aids group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shared decision making using decision aids,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard oral explanation with booklet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision aids</intervention_name>
    <description>Decision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine.</description>
    <arm_group_label>Decision aids group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The one-month-old baby's family whose age is between 20 and 80 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. . The doctor determines that the baby's family is not suitable; if baby's family&#xD;
             cannot understand Chinese languages what we said.&#xD;
&#xD;
          2. . The participants' baby who have fever or contraindication for oral rotavirus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheng-Chieh Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheng-Chieh Lin, MD</last_name>
    <phone>886-2-2249-0088</phone>
    <email>jacklinmails@yahoo.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sheng-Chieh Lin</name>
      <address>
        <city>New Taipei City</city>
        <state>No.291, Zhongzheng Road, Zhonghe District, New Taipei City</state>
        <zip>23561</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <contact>
      <last_name>Sheng-Chieh Lin, MD</last_name>
      <phone>886-2-2249-0088</phone>
      <email>jacklinmails@yahoo.com.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University Shuang Ho Hospital</investigator_affiliation>
    <investigator_full_name>Sheng-Chieh Lin</investigator_full_name>
    <investigator_title>Medical attending doctor</investigator_title>
  </responsible_party>
  <keyword>Decision Aids; Shared decision making; Rotavirus Vaccines</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03804489
org study id: 108HHC-03
nct id: NCT03804489
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Using decision aids (DA) is one way to provide information to infant family and to involve
      them in making decisions about their baby's vaccination. We developed a DA administered after
      consultation for baby's family deciding on whether the baby will receive the self-paid oral
      rotavirus vaccine
Background:

      Acute gastroenteritis is one of the most common infectious diseases and still a major cause
      of pediatric morbidity and mortality worldwide. Rotavirus was still the major cause of acute
      gastroenteritis in infants and young children worldwide, including in Taiwan. The World
      Health Organization has recommended rotavirus vaccine, which became available in 2006, for
      all countries. However, not all of children in Taiwan received rotavirus vaccination. Using
      decision aids (DA) is one way to provide information to infant family and to involve them in
      making decisions about their baby's vaccination. We developed a DA administered after
      consultation for baby's family deciding on whether the baby will receive the self-paid oral
      rotavirus vaccine Patients and Methods Decision aids are interventions designed to help
      infant family make choices among options by providing information relevant to oral rotavirus
      vaccine. Infant coming to receiving regular routine vaccination at 1 month old are randomly
      assigned to receive a DA or the standard oral conversation (control condition) after the
      initial consultation. Infant family complete interview-based questionnaires 1 month later
      when they came back to hospital receiving 2-month-old regular routine vaccination and decide
      to receive self-paid oral rotavirus vaccine or not at that time. Primary outcome measures:
      decisional conflict and decision-making difficulties at 2-month-old.

      Results and Conclusion The DA group are predicted to lower decisional conflict scores when
      compared with the control group. Our study hopes to support the efficacy of DA in helping the
      infant family to decide whether the baby will receive the self-paid oral rotavirus vaccine.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Decision aids
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Decisional conflict
time frame: An average of 1 month after intervention
description: Total score of decisional conflict scale
measure: Decision-making difficulties
time frame: An average of 1 month after intervention
description: Total score of decision-making scale
arm group label: Decision aids group
arm group type: Experimental
description: Shared decision making using decision aids,
arm group label: Control group
arm group type: No Intervention
description: Standard oral explanation with booklet.
intervention type: Other
intervention name: Decision aids
description: Decision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine.
arm group label: Decision aids group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sheng-Chieh Lin, MD
role: Principal Investigator
affiliation: Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University
last name: Sheng-Chieh Lin, MD
phone: 886-2-2249-0088
email: jacklinmails@yahoo.com.tw
facility: 
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University Shuang Ho Hospital
investigator full name: Sheng-Chieh Lin
investigator title: Medical attending doctor
sharing ipd: Undecided