<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/NCT03241212</url>
  </required_header>
  <id_info>
    <org_study_id>17-1135</org_study_id>
    <nct_id>NCT03241212</nct_id>
  </id_info>
  <brief_title>Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting</brief_title>
  <acronym>ASKED-IT</acronym>
  <official_title>Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</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>
      This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What&#xD;
      I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a&#xD;
      validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3&#xD;
      months and 6 months. The intervention group will receive a minimum of 78 text messages&#xD;
      related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited&#xD;
      to respond to some text messages which will be in the form of a multiple-choice question and&#xD;
      if they do, they will receive an additional text message in response to their answer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">December 14, 2018</completion_date>
  <primary_completion_date type="Actual">December 14, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knowledge about type 1 diabetes</measure>
    <time_frame>6 months from intervention</time_frame>
    <description>Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes self-care practices</measure>
    <time_frame>at 3 months and 6 months</time_frame>
    <description>Assessed by the Self-Management of Type 1 Diabetes in Adolescents (SMOD-A) tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hemoglobin A1c</measure>
    <time_frame>at 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood glucose testing frequency</measure>
    <time_frame>at 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percent of blood glucoses high, in range and low</measure>
    <time_frame>at 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of text messages responded to in the study.</measure>
    <time_frame>After 6 months of texting intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>At baseline enrollment: participants will be asked to fill out a demographic survey, the MWIKAD survey and the SMOD-A survey. HbA1c, frequency of Blood Glucose (BG) checks and percent of glucose values above, within and below the target range will be extracted from chart review.&#xD;
Surveys (with the exception of demographics) and chart extraction will be repeated at 3 months and 6 months post enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Texting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to complete the same surveys on the same timeline as above. The texting group will be asked to provide their cell phone number to the texting software.&#xD;
From baseline appointment to 26 weeks post enrollment, participants will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Texting</intervention_name>
    <description>From baseline appointment to 6 month follow up, those participants randomly assigned to the texting intervention will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.</description>
    <arm_group_label>Texting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of type 1 diabetes mellitus&#xD;
&#xD;
          2. Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)&#xD;
&#xD;
          3. Age 15-20 at study enrollment&#xD;
&#xD;
          4. English literate and English speaking&#xD;
&#xD;
          5. Ability to complete the required surveys&#xD;
&#xD;
          6. Have a personal cell phone with service compatible with EZTexting Platform&#xD;
&#xD;
          7. Able to provide informed assent or consent (if 18 years of age or older) and parental&#xD;
             informed consent (if needed).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Not planning to continue care in the pediatric clinic at BDC for at least the next 6&#xD;
             months.&#xD;
&#xD;
          2. Diabetes Diagnosis other than Type 1 Diabetes&#xD;
&#xD;
          3. Inability for the adolescent to respond to text messages (e.g. due to developmental&#xD;
             delay)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonalee Ravi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barbara Davis Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>800045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>May 30, 2019</last_update_submitted>
  <last_update_submitted_qc>May 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adolescent</keyword>
  <keyword>young adult</keyword>
  <keyword>knowledge</keyword>
  <keyword>self-care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03241212
org study id: 17-1135
nct id: NCT03241212
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What
      I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a
      validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3
      months and 6 months. The intervention group will receive a minimum of 78 text messages
      related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited
      to respond to some text messages which will be in the form of a multiple-choice question and
      if they do, they will receive an additional text message in response to their answer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in knowledge about type 1 diabetes
time frame: 6 months from intervention
description: Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)
measure: Change in diabetes self-care practices
time frame: at 3 months and 6 months
description: Assessed by the Self-Management of Type 1 Diabetes in Adolescents (SMOD-A) tool
measure: Change in Hemoglobin A1c
time frame: at 3 months and 6 months
measure: Change in blood glucose testing frequency
time frame: at 3 months and 6 months
measure: Change in percent of blood glucoses high, in range and low
time frame: at 3 months and 6 months
measure: Percent of text messages responded to in the study.
time frame: After 6 months of texting intervention
arm group label: Control
arm group type: No Intervention
description: At baseline enrollment: participants will be asked to fill out a demographic survey, the MWIKAD survey and the SMOD-A survey. HbA1c, frequency of Blood Glucose (BG) checks and percent of glucose values above, within and below the target range will be extracted from chart review.
Surveys (with the exception of demographics) and chart extraction will be repeated at 3 months and 6 months post enrollment.
arm group label: Texting
arm group type: Experimental
description: Participants will be asked to complete the same surveys on the same timeline as above. The texting group will be asked to provide their cell phone number to the texting software.
From baseline appointment to 26 weeks post enrollment, participants will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.
intervention type: Behavioral
intervention name: Texting
description: From baseline appointment to 6 month follow up, those participants randomly assigned to the texting intervention will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.
arm group label: Texting
criteria: 
gender: All
minimum age: 15 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sonalee Ravi, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No