<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/NCT02969954</url>
  </required_header>
  <id_info>
    <org_study_id>16-005091</org_study_id>
    <nct_id>NCT02969954</nct_id>
  </id_info>
  <brief_title>Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Diabetes</brief_title>
  <official_title>Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Reduction of Diabetes-Related Health Disparities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Racial and ethnic minorities with type II diabetes in the US are more likely to develop&#xD;
      complications and die from the disease than the general population. The foreign-born subset&#xD;
      of this population is less likely to adhere to diabetes care recommendations than US-born&#xD;
      patients, thereby placing them at higher risk for complications. In our previous pilot&#xD;
      project, eight stories were assessed through preliminary multi-site intervention for&#xD;
      acceptability and efficacy in diabetes management among Latino and Somali patients with&#xD;
      poorly controlled type II diabetes. The goal of this project is to evaluate a new format for&#xD;
      delivery of a culturally tailored digital storytelling intervention by incorporating a&#xD;
      facilitated group discussion following the videos, for management of type II diabetes in&#xD;
      Latino communities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-efficacy for diabetes management</measure>
    <time_frame>Assessment will be done immediately after participants watch the intervention video</time_frame>
    <description>The evaluation will assess the degree to which the intervention motivates the patient to improve self-management of diabetes. The evaluation will also assess overall acceptability. Items for this survey were adapted from a well validated health communication assessment tool produced by the National Cancer Institute.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study has one arm - who will all receive the intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-efficacy for diabetes management</intervention_name>
    <description>Participants at both sites will watch a 12 minute video featuring the digital stories on diabetes. Following the video, participants will engage in a brief facilitated discussion regarding motivations and barriers to diabetes management, led by a trained Spanish-speaking facilitator.</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Self-identify as Hispanic/Latino&#xD;
&#xD;
          2. Are Spanish-speaking&#xD;
&#xD;
          3. Receive primary care at one of the participating clinical sites&#xD;
&#xD;
          4. Self-reported diagnosis of type II diabetes&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Not able to give informed consent&#xD;
&#xD;
          2. Not able to participate in a group discussion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane W Njeru</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>February 12, 2018</last_update_submitted>
  <last_update_submitted_qc>February 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Jane W. Njeru, M.B., Ch.B.</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- 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/NCT02969954
org study id: 16-005091
nct id: NCT02969954
lead sponsor: 
has dmc: No
Racial and ethnic minorities with type II diabetes in the US are more likely to develop
      complications and die from the disease than the general population. The foreign-born subset
      of this population is less likely to adhere to diabetes care recommendations than US-born
      patients, thereby placing them at higher risk for complications. In our previous pilot
      project, eight stories were assessed through preliminary multi-site intervention for
      acceptability and efficacy in diabetes management among Latino and Somali patients with
      poorly controlled type II diabetes. The goal of this project is to evaluate a new format for
      delivery of a culturally tailored digital storytelling intervention by incorporating a
      facilitated group discussion following the videos, for management of type II diabetes in
      Latino communities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Self-efficacy for diabetes management
time frame: Assessment will be done immediately after participants watch the intervention video
description: The evaluation will assess the degree to which the intervention motivates the patient to improve self-management of diabetes. The evaluation will also assess overall acceptability. Items for this survey were adapted from a well validated health communication assessment tool produced by the National Cancer Institute.
arm group label: Intervention arm
arm group type: Experimental
description: Study has one arm - who will all receive the intervention
intervention type: Other
intervention name: Self-efficacy for diabetes management
description: Participants at both sites will watch a 12 minute video featuring the digital stories on diabetes. Following the video, participants will engage in a brief facilitated discussion regarding motivations and barriers to diabetes management, led by a trained Spanish-speaking facilitator.
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jane W Njeru
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Jane W. Njeru, M.B., Ch.B.
investigator title: PI
mesh term: Diabetes Mellitus