<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/NCT04484896</url>
  </required_header>
  <id_info>
    <org_study_id>Recruiting Rh-D- blood donors</org_study_id>
    <nct_id>NCT04484896</nct_id>
  </id_info>
  <brief_title>Message Framing on Recruiting Rh-D Negative Blood Donors</brief_title>
  <official_title>Effects of Message Framing on Recruiting Rh-D Negative Blood Donors in an Emergency Situation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Blood Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Blood Center</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>
      Rh negative blood group is a rare blood group in China, as it only accounts for 0.3-0.4&#xD;
      percent of the Han population. Therefore, low inventory is often found in blood collection&#xD;
      and supply agencies in many regions in China. On July 22, 2020 blood stockpile of O-negative&#xD;
      and A-negative in Guangzhou Blood Center reached the warning line, and we took measures for&#xD;
      emergency recruitment. O-negative and A-negative blood donors whose last donation dates were&#xD;
      between January 1, 2018 and December 31, 2019 were identified and randomly assigned to four&#xD;
      groups. Three different recruitment text messages were send three groups. We observed the&#xD;
      re-donation rates among four groups within one week.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 29, 2020</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant did not know the difference between the three message.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Re-donation rate</measure>
    <time_frame>7 days</time_frame>
    <description>Intention-to-treat were applied. Re-donation rate was defined as the number of donors in each group divided by donors who re-donated within 7 days.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1082</enrollment>
  <condition>Blood Donation</condition>
  <arm_group>
    <arm_group_label>Gain-frame Message</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Short messaging service (SMS) message: Dear group O/A Rh-D negative blood donor:&#xD;
Hello! The inventory of group O/A Rh-D negative blood product is low at present, but patients with such blood group are in urgent need of blood. If you can, please consider donating blood again to save lives. Thank you for your support.&#xD;
Please bring your identification (ID) card and show this message to our staff. Thank you.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loss-frame Message</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SMS message: Dear group O/A Rh-D negative blood donor:&#xD;
Hello! The inventory of group O/A Rh-D negative blood product is low at present, but patients with such blood group are in urgent need of blood. If you can, please consider donating blood again to prevent the loss of life. Thank you for your support.&#xD;
Please bring your ID card and show this message to our staff. Thank you.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information Message</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SMS message: Dear group O/A Rh-D negative blood donor:&#xD;
Hello! The inventory of group O/A Rh-D negative blood product is low at present, if you can, please consider donating blood again. Thank you for your support.&#xD;
Please bring your ID card and show this message to our staff. Thank you.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Donors in this group were not received SMS reminders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gain-framed SMS message</intervention_name>
    <description>Emergency recruitment cell phone short messages that emphasizing donating blood can save patients' lives were sent to donors in this group.</description>
    <arm_group_label>Gain-frame Message</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Loss-framed SMS message</intervention_name>
    <description>Emergency recruitment cell phone short messages emphasizing that donating blood can prevent patients from death were sent to donors in this group.</description>
    <arm_group_label>Loss-frame Message</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information SMS message</intervention_name>
    <description>Emergency recruitment cell phone short messages that only mentioning the low Rh-negative blood stockpile were sent to donors in this group.</description>
    <arm_group_label>Information Message</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - O and A Rh- negative blood donors Last donations were between January 1, 2018 and&#xD;
        December 31, 2019&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - With an obviously invalid phone number Serological results of the last donation were&#xD;
        positive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jian OU-YANG</last_name>
    <phone>+8615918771924</phone>
    <email>434524249@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guangzhou Blood Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510095</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian OUYANG, Master</last_name>
      <phone>0086 15918771924</phone>
      <email>434524249@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04484896
org study id: Recruiting Rh-D- blood donors
nct id: NCT04484896
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rh negative blood group is a rare blood group in China, as it only accounts for 0.3-0.4
      percent of the Han population. Therefore, low inventory is often found in blood collection
      and supply agencies in many regions in China. On July 22, 2020 blood stockpile of O-negative
      and A-negative in Guangzhou Blood Center reached the warning line, and we took measures for
      emergency recruitment. O-negative and A-negative blood donors whose last donation dates were
      between January 1, 2018 and December 31, 2019 were identified and randomly assigned to four
      groups. Three different recruitment text messages were send three groups. We observed the
      re-donation rates among four groups within one week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
masking description: Participant did not know the difference between the three message.
measure: Re-donation rate
time frame: 7 days
description: Intention-to-treat were applied. Re-donation rate was defined as the number of donors in each group divided by donors who re-donated within 7 days.
arm group label: Gain-frame Message
arm group type: Experimental
description: Short messaging service (SMS) message: Dear group O/A Rh-D negative blood donor:
Hello! The inventory of group O/A Rh-D negative blood product is low at present, but patients with such blood group are in urgent need of blood. If you can, please consider donating blood again to save lives. Thank you for your support.
Please bring your identification (ID) card and show this message to our staff. Thank you.
arm group label: Loss-frame Message
arm group type: Experimental
description: SMS message: Dear group O/A Rh-D negative blood donor:
Hello! The inventory of group O/A Rh-D negative blood product is low at present, but patients with such blood group are in urgent need of blood. If you can, please consider donating blood again to prevent the loss of life. Thank you for your support.
Please bring your ID card and show this message to our staff. Thank you.
arm group label: Information Message
arm group type: Experimental
description: SMS message: Dear group O/A Rh-D negative blood donor:
Hello! The inventory of group O/A Rh-D negative blood product is low at present, if you can, please consider donating blood again. Thank you for your support.
Please bring your ID card and show this message to our staff. Thank you.
arm group label: Control group
arm group type: No Intervention
description: Donors in this group were not received SMS reminders.
intervention type: Other
intervention name: Gain-framed SMS message
description: Emergency recruitment cell phone short messages that emphasizing donating blood can save patients' lives were sent to donors in this group.
arm group label: Gain-frame Message
intervention type: Other
intervention name: Loss-framed SMS message
description: Emergency recruitment cell phone short messages emphasizing that donating blood can prevent patients from death were sent to donors in this group.
arm group label: Loss-frame Message
intervention type: Other
intervention name: Information SMS message
description: Emergency recruitment cell phone short messages that only mentioning the low Rh-negative blood stockpile were sent to donors in this group.
arm group label: Information Message
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jian OU-YANG
phone: +8615918771924
email: 434524249@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
sharing ipd: Undecided