<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/NCT03766438</url>
  </required_header>
  <id_info>
    <org_study_id>18-002998</org_study_id>
    <secondary_id>R01DK113999-01A1</secondary_id>
    <nct_id>NCT03766438</nct_id>
  </id_info>
  <brief_title>Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults</brief_title>
  <acronym>S4C</acronym>
  <official_title>Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hennepin Healthcare, Minneapolis, MN</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mountain Park Health Center - Phoenix, AZ</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
      Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more&#xD;
      likely to die from the disease than non-Hispanic whites. These disparities are mediated, in&#xD;
      part, by less healthful levels of physical activity, dietary quality, medication adherence,&#xD;
      and self-monitoring of blood glucose than non-Hispanic whites. Innovative approaches that&#xD;
      arise from affected communities are needed to address these health disparities.&#xD;
&#xD;
      Community-based participatory research (CBPR) has been successful in targeting health issues&#xD;
      among Hispanic and immigrant populations; CBPR is an effective approach for addressing health&#xD;
      behaviors in a sociocultural context. In 2004, the research team developed a CBPR partnership&#xD;
      between immigrant communities and academic institutions called Rochester Healthy Community&#xD;
      Partnership (RHCP)&#xD;
&#xD;
      Storytelling or narrative-based interventions are designed to incorporate culture-centric&#xD;
      health messaging to promote behavior change among vulnerable populations. Digital&#xD;
      storytelling interventions are narrative-based videos elicited through a CBPR approach to&#xD;
      surface the authentic voices of individuals overcoming obstacles toward engaging in health&#xD;
      promoting behaviors to shape positive health behaviors of viewers through influences on&#xD;
      attitudes and beliefs.&#xD;
&#xD;
      RHCP partners from Hispanic communities identified T2D as a priority area for intervention,&#xD;
      and have co-created each of the formative phases leading up to this proposal. Narrative&#xD;
      theory and social cognitive theory formed the conceptual basis for intervention development.&#xD;
      The study team conducted surveys and focus groups to derive the approach and personnel for&#xD;
      building an authentic intervention that was created in a digital storytelling workshop where&#xD;
      stories about diabetes self-management were captured, recorded, and edited to derive the&#xD;
      final intervention products in video forma. The respective digital storytelling videos were&#xD;
      pilot tested with 25 patients across healthcare institutions in Minnesota and Arizona. The&#xD;
      intervention was rated as highly acceptable, culturally relevant, and perceived as&#xD;
      efficacious for motivating behavioral change.&#xD;
&#xD;
      The overall objective of this project is therefore to assess the efficacy of a digital&#xD;
      storytelling intervention derived through a CBPR approach on self-management of T2D among&#xD;
      Hispanic adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study team will conduct a two-group randomized controlled trial in primary care clinical&#xD;
      settings at two healthcare institutions among 450 Hispanic adults with poorly controlled T2D&#xD;
      (hemoglobin A1c≥8%). The intervention group will view the 12-minute digital storytelling&#xD;
      video. Both the intervention and comparison groups will receive diabetes education and&#xD;
      resource cards, as well as usual clinical care. The primary outcome will be glycemic control&#xD;
      as measured by hemoglobin A1c 3 months after intervention delivery. Secondary outcomes will&#xD;
      include diabetes self-management behaviors, blood pressure, LDL-cholesterol, and body mass&#xD;
      index. The impact of concomitant covariates, including sex, age, and socio-economic status,&#xD;
      on the sensitivity of the intervention effect will also be explored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Actual">March 25, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control as measured by hemoglobin A1c. Hemoglobin A1c will be measured from whole blood samples obtained and analyzed in a blinded fashion.</measure>
    <time_frame>6 months.</time_frame>
    <description>The rationale for use of hemoglobin A1c as an indicator of diabetes control is based on national and regional data that demonstrate significant disparities in reaching hemoglobin A1c targets for Hispanic populations compared with non-Hispanic whites. The importance of glycemic control as part of the comprehensive management of diabetes is well documented, and hemoglobin A1c testing is a well-established strategy to monitor glycemic control in patients with diabetes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diabetes self-management behaviors will be assessed with the Summary of Diabetes Self-Care Activities Measure (SDSCA).</measure>
    <time_frame>6 months.</time_frame>
    <description>This is a brief survey instrument to assess the following domains: general diet, specific (diabetes) diet, physical activity, diabetes medication use, and blood glucose monitoring. In a 2009 review of psychometric tools to assess diabetes self-management behaviors, the SDSCA was one of only three instruments to meet all appraisal criteria113. The SDSCA is also the most commonly used instrument for these domains worldwide, with good validity evidence in several languages, including Spanish114,115. Furthermore, we used this instrument with Hispanic/Latino patients during the early phase (Step 1) for this project22. The SDSCA will be administered by the same language-congruent study staff at each measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seated blood pressure measurements (systolic and diastolic) will be made on the right arm using an automated blood pressure device after sitting quietly for five minutes.</measure>
    <time_frame>6 months</time_frame>
    <description>Blood pressure will be measured three times; the average of the second and third readings will be used in statistical analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>6 months</time_frame>
    <description>Weight will be measured to the nearest 0.1 kg using a clinical scale. Height will be measured in cm with a stadiometer. BMI is calculated as weight (kg)/height squared (m2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol, HDL cholesterol, and triglycerides will be measured from the same blood sample used to derive the outcome measure. LDL-cholesterol will be calculated for each participant based on these values.</measure>
    <time_frame>3 months</time_frame>
    <description>Baseline LDL-cholesterol values will be drawn at the baseline study visit. Cholesterol values at 3 months will be drawn at the 3 month study visit. Subsequent cholesterol levels will not be drawn or abstracted.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The comparison group will receive usual clinical care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Digital Storytelling Intervention</intervention_name>
    <description>12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Self-identifies as Hispanic or Latino.&#xD;
&#xD;
          2. Between 18 and 70 years of age.&#xD;
&#xD;
          3. Receives primary care at the clinical site.&#xD;
&#xD;
          4. Visited the primary care site at least once in the least twelve months.&#xD;
&#xD;
          5. Intention to continue receiving care at the clinic for the next six months.&#xD;
&#xD;
          6. Diagnosis of T2D in medical record.&#xD;
&#xD;
          7. T2D diagnosis for six months or longer.&#xD;
&#xD;
          8. Most recent hemoglobin A1c≥8%.&#xD;
&#xD;
        Not eligible if someone in the same household is participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark L Wieland</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mountain Park Health Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin Healthcare</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Mark L Wieland</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03766438
org study id: 18-002998
secondary id: R01DK113999-01A1
nct id: NCT03766438
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more
      likely to die from the disease than non-Hispanic whites. These disparities are mediated, in
      part, by less healthful levels of physical activity, dietary quality, medication adherence,
      and self-monitoring of blood glucose than non-Hispanic whites. Innovative approaches that
      arise from affected communities are needed to address these health disparities.

      Community-based participatory research (CBPR) has been successful in targeting health issues
      among Hispanic and immigrant populations; CBPR is an effective approach for addressing health
      behaviors in a sociocultural context. In 2004, the research team developed a CBPR partnership
      between immigrant communities and academic institutions called Rochester Healthy Community
      Partnership (RHCP)

      Storytelling or narrative-based interventions are designed to incorporate culture-centric
      health messaging to promote behavior change among vulnerable populations. Digital
      storytelling interventions are narrative-based videos elicited through a CBPR approach to
      surface the authentic voices of individuals overcoming obstacles toward engaging in health
      promoting behaviors to shape positive health behaviors of viewers through influences on
      attitudes and beliefs.

      RHCP partners from Hispanic communities identified T2D as a priority area for intervention,
      and have co-created each of the formative phases leading up to this proposal. Narrative
      theory and social cognitive theory formed the conceptual basis for intervention development.
      The study team conducted surveys and focus groups to derive the approach and personnel for
      building an authentic intervention that was created in a digital storytelling workshop where
      stories about diabetes self-management were captured, recorded, and edited to derive the
      final intervention products in video forma. The respective digital storytelling videos were
      pilot tested with 25 patients across healthcare institutions in Minnesota and Arizona. The
      intervention was rated as highly acceptable, culturally relevant, and perceived as
      efficacious for motivating behavioral change.

      The overall objective of this project is therefore to assess the efficacy of a digital
      storytelling intervention derived through a CBPR approach on self-management of T2D among
      Hispanic adults.
The study team will conduct a two-group randomized controlled trial in primary care clinical
      settings at two healthcare institutions among 450 Hispanic adults with poorly controlled T2D
      (hemoglobin A1c≥8%). The intervention group will view the 12-minute digital storytelling
      video. Both the intervention and comparison groups will receive diabetes education and
      resource cards, as well as usual clinical care. The primary outcome will be glycemic control
      as measured by hemoglobin A1c 3 months after intervention delivery. Secondary outcomes will
      include diabetes self-management behaviors, blood pressure, LDL-cholesterol, and body mass
      index. The impact of concomitant covariates, including sex, age, and socio-economic status,
      on the sensitivity of the intervention effect will also be explored.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Glycemic control as measured by hemoglobin A1c. Hemoglobin A1c will be measured from whole blood samples obtained and analyzed in a blinded fashion.
time frame: 6 months.
description: The rationale for use of hemoglobin A1c as an indicator of diabetes control is based on national and regional data that demonstrate significant disparities in reaching hemoglobin A1c targets for Hispanic populations compared with non-Hispanic whites. The importance of glycemic control as part of the comprehensive management of diabetes is well documented, and hemoglobin A1c testing is a well-established strategy to monitor glycemic control in patients with diabetes.
measure: Diabetes self-management behaviors will be assessed with the Summary of Diabetes Self-Care Activities Measure (SDSCA).
time frame: 6 months.
description: This is a brief survey instrument to assess the following domains: general diet, specific (diabetes) diet, physical activity, diabetes medication use, and blood glucose monitoring. In a 2009 review of psychometric tools to assess diabetes self-management behaviors, the SDSCA was one of only three instruments to meet all appraisal criteria113. The SDSCA is also the most commonly used instrument for these domains worldwide, with good validity evidence in several languages, including Spanish114,115. Furthermore, we used this instrument with Hispanic/Latino patients during the early phase (Step 1) for this project22. The SDSCA will be administered by the same language-congruent study staff at each measure.
measure: Seated blood pressure measurements (systolic and diastolic) will be made on the right arm using an automated blood pressure device after sitting quietly for five minutes.
time frame: 6 months
description: Blood pressure will be measured three times; the average of the second and third readings will be used in statistical analyses.
measure: Body mass index
time frame: 6 months
description: Weight will be measured to the nearest 0.1 kg using a clinical scale. Height will be measured in cm with a stadiometer. BMI is calculated as weight (kg)/height squared (m2).
measure: Total cholesterol, HDL cholesterol, and triglycerides will be measured from the same blood sample used to derive the outcome measure. LDL-cholesterol will be calculated for each participant based on these values.
time frame: 3 months
description: Baseline LDL-cholesterol values will be drawn at the baseline study visit. Cholesterol values at 3 months will be drawn at the 3 month study visit. Subsequent cholesterol levels will not be drawn or abstracted.
arm group label: Intervention
arm group type: Experimental
description: The intervention group will view the 12-minute digital storytelling intervention that has been previously pilot-tested, in addition to usual clinical care.
arm group label: Control
arm group type: No Intervention
description: The comparison group will receive usual clinical care.
intervention type: Behavioral
intervention name: Digital Storytelling Intervention
description: 12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mark L Wieland
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Mark L Wieland
investigator title: Principal Investigator
mesh term: Diabetes Mellitus