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/NCT06033313</url>
    </required_header>
    <id_info>
      <org_study_id>19-221</org_study_id>
      <nct_id>NCT06033313</nct_id>
    </id_info>
    <brief_title>Effects of Framing on Medication Beliefs, Intentions to Take Medication, Adherence, and Asthma Control</brief_title>
    <official_title>Examining the Effect of Message Framing on Medication Beliefs, Intentions to Take Medications, Adherence to Medication, and Asthma Control Among College Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Auburn University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Auburn 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>
        The goal of this study is to examine the effects of framed mobile messages on young adults'&#xD;
        beliefs about their daily Inhaled Corticosteroids (ICS), intentions to take their ICS,&#xD;
        adherence, and asthma control. College students (18-29 years) who owned a mobile phone and&#xD;
        had a diagnosis of asthma with a prescription for an ICS will be recruited. Participants will&#xD;
        be randomized to receive either gain- or loss-framed mobile messages three times per week for&#xD;
        eight weeks. Outcomes including beliefs, intentions, adherence, and asthma control will be&#xD;
        assessed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2019</start_date>
    <completion_date type="Actual">November 30, 2019</completion_date>
    <primary_completion_date type="Actual">November 30, 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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in Asthma control</measure>
      <time_frame>Data collection at baseline, week 4, and week 8</time_frame>
      <description>Asthma control as measured by the Asthma Control Test (minimum value=5, maximum value= 25) Questionnaire (scores of 20 and above indicate asthma control)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in Medication Beliefs</measure>
      <time_frame>Data collection at baseline and week 8</time_frame>
      <description>Medication Beliefs as measured by the Beliefs about Medicines Questionnaire-Specific (This scale has two sub-scales : necessity (20- points) and concerns (20 points). A difference of necessity and concern scores shows the level of perceived necessity for the medication. Higher scores indicate higher perceived necessity for the medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intentions to take medication as prescribed</measure>
      <time_frame>Data collection at baseline and week 8</time_frame>
      <description>Intentions to take inhaled corticosteroids as prescribed as measured by an intentions scale (minimum score = 3, maximum score = 15; higher scores indicate greater intentions; the scale was tested in the study)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Medication adherence</measure>
      <time_frame>Data collection at baseline, week 4, and week 8</time_frame>
      <description>Adherence to a daily dose of inhaled corticosteroid as measured by the Medication Adherence Report Scale for Asthma (MARS-A) (Minimum score = 10, maximum score = 50, higher scores indicate greater adherence)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">43</enrollment>
    <condition>Asthma</condition>
    <arm_group>
      <arm_group_label>Positively framed text messages</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Positively framed text messages</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Negatively frame text messages</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Negatively framed text messages</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Negatively Framed text messages</intervention_name>
      <description>Negatively Framed text messages delivered to participants three times per week for 8 weeks.</description>
      <arm_group_label>Negatively frame text messages</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Positively Framed text messages</intervention_name>
      <description>Positively Framed text messages delivered to participants three times per week for 8 weeks.</description>
      <arm_group_label>Positively framed text messages</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A diagnosis of asthma&#xD;
  &#xD;
            -  A prescription for an inhaled corticosteroid&#xD;
  &#xD;
            -  Enrolled in college&#xD;
  &#xD;
            -  Between 18-29 years of age&#xD;
  &#xD;
            -  Owns a mobile phone&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cannot read in english&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>29 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Auburn University</name>
        <address>
          <city>Auburn</city>
          <state>Alabama</state>
          <zip>36849</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Auburn University</investigator_affiliation>
      <investigator_full_name>Ruth Jeminiwa</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>mHealth</keyword>
    <keyword>message framing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data available upon request</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Immediately available upon request for the next 10-20 years</ipd_time_frame>
      <ipd_access_criteria>This is not applicable</ipd_access_criteria>
    </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/NCT06033313
  org study id: 19-221
  nct id: NCT06033313
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to examine the effects of framed mobile messages on young adults'
        beliefs about their daily Inhaled Corticosteroids (ICS), intentions to take their ICS,
        adherence, and asthma control. College students (18-29 years) who owned a mobile phone and
        had a diagnosis of asthma with a prescription for an ICS will be recruited. Participants will
        be randomized to receive either gain- or loss-framed mobile messages three times per week for
        eight weeks. Outcomes including beliefs, intentions, adherence, and asthma control will be
        assessed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Changes in Asthma control
  time frame: Data collection at baseline, week 4, and week 8
  description: Asthma control as measured by the Asthma Control Test (minimum value=5, maximum value= 25) Questionnaire (scores of 20 and above indicate asthma control)
  measure: Changes in Medication Beliefs
  time frame: Data collection at baseline and week 8
  description: Medication Beliefs as measured by the Beliefs about Medicines Questionnaire-Specific (This scale has two sub-scales : necessity (20- points) and concerns (20 points). A difference of necessity and concern scores shows the level of perceived necessity for the medication. Higher scores indicate higher perceived necessity for the medication.
  measure: Intentions to take medication as prescribed
  time frame: Data collection at baseline and week 8
  description: Intentions to take inhaled corticosteroids as prescribed as measured by an intentions scale (minimum score = 3, maximum score = 15; higher scores indicate greater intentions; the scale was tested in the study)
  measure: Changes in Medication adherence
  time frame: Data collection at baseline, week 4, and week 8
  description: Adherence to a daily dose of inhaled corticosteroid as measured by the Medication Adherence Report Scale for Asthma (MARS-A) (Minimum score = 10, maximum score = 50, higher scores indicate greater adherence)
  arm group label: Positively framed text messages
  arm group type: Experimental
  description: Positively framed text messages
  arm group label: Negatively frame text messages
  arm group type: Experimental
  description: Negatively framed text messages
  intervention type: Behavioral
  intervention name: Negatively Framed text messages
  description: Negatively Framed text messages delivered to participants three times per week for 8 weeks.
  arm group label: Negatively frame text messages
  intervention type: Behavioral
  intervention name: Positively Framed text messages
  description: Positively Framed text messages delivered to participants three times per week for 8 weeks.
  arm group label: Positively framed text messages
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 29 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Auburn University
  investigator full name: Ruth Jeminiwa
  investigator title: Principal Investigator
  mesh term: Asthma
  sharing ipd: Yes
  ipd description: Data available upon request
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Immediately available upon request for the next 10-20 years
  ipd access criteria: This is not applicable