<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/NCT04404556</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0162</org_study_id>
    <nct_id>NCT04404556</nct_id>
  </id_info>
  <brief_title>Diabetes Journey: An Adolescent Adherence Barriers Intervention</brief_title>
  <official_title>Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to examine the feasibility, acceptability, and preliminary&#xD;
      efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring,&#xD;
      counting carbohydrates, and intensive insulin delivery via injections or insulin pump in&#xD;
      response to food intake, exercise, and illness to achieve near-normal blood glucose levels.&#xD;
      Evidence demonstrates that adhering to T1D treatment is challenging, especially during&#xD;
      adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise&#xD;
      health and quality of life. Suboptimal adherence to T1D treatment regimen is common in &gt;50%&#xD;
      of adolescents and directly related to suboptimal glycemic control, increased risk of&#xD;
      hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life&#xD;
      (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge,&#xD;
      skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to&#xD;
      overcome these barriers in order to benefit from technological advances. Thus, there is a&#xD;
      clear need for behaviorally focused interventions to identify and reduce adherence barriers.&#xD;
      The overall objective of this study is to identify adolescents with elevated adherence&#xD;
      barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these&#xD;
      barriers. This study is two phases and includes a small pilot of up to 12 adolescents with&#xD;
      type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The&#xD;
      randomized controlled clinical trial will examine feasibility, acceptability and preliminary&#xD;
      efficacy of Diabetes Journey versus enhanced standard of care (control group) in&#xD;
      approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include&#xD;
      adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and&#xD;
      acceptability will also be examined. Mediators and moderators will include executive&#xD;
      functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia&#xD;
      and sleep.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>Participants will be randomized to one of two conditions: 1) Diabetes Journey or 2) Enhanced Standard of Care.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>Outcome measures are patient-reported and thus masking will not occur at the level of participant, investigator or outcomes assessor.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Barriers to Diabetes Adherence questionnaire-Youth report Stress/Burnout Subscale</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Adherence Barrier</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barriers to Diabetes Adherence questionnaire - Youth report Time Pressure/Planning Subscale</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Adherence Barrier2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence for Continuous Glucose Monitors</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>% Time in Range for those on continuous glucose monitors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>6-month follow-up</time_frame>
    <description># blood glucose checks per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence for Insulin Pump Users</measure>
    <time_frame>6-month follow-up</time_frame>
    <description># carbohydrate entries per day for insulin pump users</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence for Insulin Pump Users 1</measure>
    <time_frame>6-month follow-up</time_frame>
    <description># insulin boluses per day for insulin pump users</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence for Insulin Pump Users 2</measure>
    <time_frame>6-month follow-up</time_frame>
    <description># insulin boluses followed by high blood glucose input per day for insulin pump users</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1C</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Fingerstick Blood Sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type 1 Diabetes and Life -Youth Report</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Quality of Life Scores range from 0-100, with higher scores indicating better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type 1 Diabetes and Life -Parent Report</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Quality of Life Scores range from 0-100, with higher scores indicating better quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">256</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Adherence, Patient</condition>
  <arm_group>
    <arm_group_label>Diabetes Journey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diabetes Journey</intervention_name>
    <description>Web-based telehealth intervention focused on adherence barriers and problem-solving</description>
    <arm_group_label>Diabetes Journey</arm_group_label>
    <other_name>mHealth problem-solving adherence barriers intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Standard of Care</intervention_name>
    <description>General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.</description>
    <arm_group_label>Enhanced Standard of Care</arm_group_label>
    <other_name>t1dtoolkit</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  T1D diagnosis &gt;1 year&#xD;
&#xD;
          -  Adolescents with T1D ages 13-17&#xD;
&#xD;
          -  Elevations on the Barriers to Diabetes Adherence questionnaire (scores of ≥3 of 53 for&#xD;
             the Stress/Burnout and/or Time Pressure/Planning subscales) based on their previous&#xD;
             clinic visit scores&#xD;
&#xD;
          -  Ability to read/speak English (all measures are in English)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Diagnosis of significant developmental disorders (e.g., autism spectrum disorder,&#xD;
             moderate/severe developmental or intellectual disability)&#xD;
&#xD;
          -  Comorbid medical diagnoses (e.g., cystic fibrosis, asthma) with the exception of&#xD;
             endocrine disorders (e.g., Celiac disease, thyroid)&#xD;
&#xD;
          -  No use of/plans to use non-insulin medication for blood glucose control&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Avani C Modi, Ph.D.</last_name>
    <phone>513-636-4864</phone>
    <email>avani.modi@cchmc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kimberly A Driscoll, Ph.D.</last_name>
    <phone>352-273-6145</phone>
    <email>k.driscoll@phhp.ufl.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610-0165</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberly Driscoll, Ph.D.</last_name>
      <phone>352-273-6145</phone>
      <email>k.driscoll@phhp.ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Kimberly Driscoll, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Avani Modi, Ph.D.</last_name>
      <phone>513-636-4864</phone>
      <email>avani.modi@cchmc.org</email>
    </contact>
    <investigator>
      <last_name>Avani C Modi, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>October 3, 2022</last_update_submitted>
  <last_update_submitted_qc>October 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent</keyword>
  <keyword>mHealth</keyword>
  <keyword>executive functioning skills</keyword>
  <keyword>adherence barriers</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>Yes</sharing_ipd>
    <ipd_description>The NIDDK Data Repository will serve as the primary data repository for the current proposal.</ipd_description>
    <ipd_time_frame>The NIDDK Data Repository will serve as the primary data repository for the current proposal. In addition, data sets may also be distributed via clinicaltrials.gov. Should individuals or organizations request the dataset directly from the principal investigators, those requests will be directed to the NIDDK Data repository to retrieve the data.&#xD;
Per NIDDK guidelines on resource sharing for intervention studies, baseline data will be shared within 2 years after study recruitment is complete or within six months of the publication date of the baseline data, whichever comes first. An analytic dataset for the baseline publication will be provided within 6 months of the publication date (when the publication appears online).</ipd_time_frame>
    <ipd_access_criteria>The investigators agree that they will identify where the data will be available and how to access the data in any publications and presentations that the investigators author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations. Since the investigators will be using the NIDDK Data Repository, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.</ipd_access_criteria>
  </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/NCT04404556
org study id: 2020-0162
nct id: NCT04404556
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the feasibility, acceptability, and preliminary
      efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D.
Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring,
      counting carbohydrates, and intensive insulin delivery via injections or insulin pump in
      response to food intake, exercise, and illness to achieve near-normal blood glucose levels.
      Evidence demonstrates that adhering to T1D treatment is challenging, especially during
      adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise
      health and quality of life. Suboptimal adherence to T1D treatment regimen is common in >50%
      of adolescents and directly related to suboptimal glycemic control, increased risk of
      hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life
      (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge,
      skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to
      overcome these barriers in order to benefit from technological advances. Thus, there is a
      clear need for behaviorally focused interventions to identify and reduce adherence barriers.
      The overall objective of this study is to identify adolescents with elevated adherence
      barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these
      barriers. This study is two phases and includes a small pilot of up to 12 adolescents with
      type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The
      randomized controlled clinical trial will examine feasibility, acceptability and preliminary
      efficacy of Diabetes Journey versus enhanced standard of care (control group) in
      approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include
      adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and
      acceptability will also be examined. Mediators and moderators will include executive
      functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia
      and sleep.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to one of two conditions: 1) Diabetes Journey or 2) Enhanced Standard of Care.
primary purpose: Treatment
masking: Single (Care Provider)
masking description: Outcome measures are patient-reported and thus masking will not occur at the level of participant, investigator or outcomes assessor.
measure: Barriers to Diabetes Adherence questionnaire-Youth report Stress/Burnout Subscale
time frame: 6-month follow-up
description: Adherence Barrier
measure: Barriers to Diabetes Adherence questionnaire - Youth report Time Pressure/Planning Subscale
time frame: 6-month follow-up
description: Adherence Barrier2
measure: Adherence for Continuous Glucose Monitors
time frame: 6-month follow-up
description: % Time in Range for those on continuous glucose monitors
measure: Adherence
time frame: 6-month follow-up
description: # blood glucose checks per day
measure: Adherence for Insulin Pump Users
time frame: 6-month follow-up
description: # carbohydrate entries per day for insulin pump users
measure: Adherence for Insulin Pump Users 1
time frame: 6-month follow-up
description: # insulin boluses per day for insulin pump users
measure: Adherence for Insulin Pump Users 2
time frame: 6-month follow-up
description: # insulin boluses followed by high blood glucose input per day for insulin pump users
measure: Hemoglobin A1C
time frame: 6-month follow-up
description: Fingerstick Blood Sample
measure: Type 1 Diabetes and Life -Youth Report
time frame: 6-month follow-up
description: Quality of Life Scores range from 0-100, with higher scores indicating better quality of life
measure: Type 1 Diabetes and Life -Parent Report
time frame: 6-month follow-up
description: Quality of Life Scores range from 0-100, with higher scores indicating better quality of life
arm group label: Diabetes Journey
arm group type: Experimental
description: Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
arm group label: Enhanced Standard of Care
arm group type: Active Comparator
description: Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
intervention type: Behavioral
intervention name: Diabetes Journey
description: Web-based telehealth intervention focused on adherence barriers and problem-solving
arm group label: Diabetes Journey
other name: mHealth problem-solving adherence barriers intervention
intervention type: Behavioral
intervention name: Enhanced Standard of Care
description: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
arm group label: Enhanced Standard of Care
other name: t1dtoolkit
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: No
last name: Avani C Modi, Ph.D.
phone: 513-636-4864
email: avani.modi@cchmc.org
last name: Kimberly A Driscoll, Ph.D.
phone: 352-273-6145
email: k.driscoll@phhp.ufl.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Yes
ipd description: The NIDDK Data Repository will serve as the primary data repository for the current proposal.
ipd time frame: The NIDDK Data Repository will serve as the primary data repository for the current proposal. In addition, data sets may also be distributed via clinicaltrials.gov. Should individuals or organizations request the dataset directly from the principal investigators, those requests will be directed to the NIDDK Data repository to retrieve the data.
Per NIDDK guidelines on resource sharing for intervention studies, baseline data will be shared within 2 years after study recruitment is complete or within six months of the publication date of the baseline data, whichever comes first. An analytic dataset for the baseline publication will be provided within 6 months of the publication date (when the publication appears online).
ipd access criteria: The investigators agree that they will identify where the data will be available and how to access the data in any publications and presentations that the investigators author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations. Since the investigators will be using the NIDDK Data Repository, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.