<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/NCT04420845</url>
  </required_header>
  <id_info>
    <org_study_id>239740</org_study_id>
    <nct_id>NCT04420845</nct_id>
  </id_info>
  <brief_title>Diabetes Self-Management Education With Sleep Hygiene</brief_title>
  <official_title>Diabetes Self-Management Education With Sleep Hygiene</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</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 will test whether adding sleep hygiene education and support to diabetes&#xD;
      self-management education and support (DSMES) in diverse patients (African American,&#xD;
      Hispanic, Pacific Islander, and Caucasian) with type 2 diabetes myelitis (T2DM) from rural&#xD;
      UAMS Regional Programs clinics is more effective than DSMES alone. The specific aims for this&#xD;
      study are:&#xD;
&#xD;
        -  Aim 1A (Primary): Determine if this model improves blood glucose levels as measured by&#xD;
           the HbA1c test in diverse adults with T2DM.&#xD;
&#xD;
        -  Aim 1B: Determine the preliminary effectiveness of DSMES+SHES on sleep duration and&#xD;
           sleep quality, blood pressure, fasting lipids, body mass index (BMI), self-management&#xD;
           behavior, self-efficacy, diabetes-related distress, and diabetes-related quality of life&#xD;
           in diverse adults with T2DM.&#xD;
&#xD;
        -  Aim 2A: Determine the feasibility and acceptability of DSMES+ SHES when implemented with&#xD;
           diverse adults with T2DM.&#xD;
&#xD;
        -  Aim 2B: Determine the feasibility and acceptability of DSMES+ SHES implementation in&#xD;
           Regional Programs clinics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study was significantly delayed due to the COVID-19 pandemic. The PI has chosen not to&#xD;
    conduct the study.&#xD;
  </why_stopped>
  <start_date type="Actual">March 25, 2022</start_date>
  <completion_date type="Actual">March 25, 2022</completion_date>
  <primary_completion_date type="Actual">March 25, 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean HbA1c (NGSP%) from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>A Siemens analyzer will be utilized to calculate HbA1c (%) for each participant at each time point. Changes in the primary outcome measure will be assessed from baseline to post-intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in sleep duration from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>Self-reported sleep duration (hours slept) will be assessed using valid Behavioral Risk Factor Surveillance System survey items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>The PROMIS® Short Form v1.0- Sleep Disturbance-4a scale will be used to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean blood pressure (systolic &amp; diastolic, mmHg) from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>Blood pressure will be measured with a sphygmomanometer and stethoscope or digital blood pressure device with the participant seated and arm elevated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean body mass index (BMI) from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>BMI will be collected by measuring participant height (without shoes) using a stadiometer, and by measuring participant weight (without shoes) using a calibrated digital scale. Participant weight and height will then be used to compute a continuous measure of BMI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean total cholesterol (mg/dL) from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>Through finger prick blood collection, point of care tests will be used used to test total cholesterol using a commercial lipid panel kit and Cholestech LDX analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean low-density lipoproteins (LDL) (mg/dL) from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>Through finger prick blood collection, point of care tests will be used used to test LDL using a commercial lipid panel kit and Cholestech LDX analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean high-density lipoproteins (HDL) (mg/dL) from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>Through finger prick blood collection, point of care tests will be used used to test HDL using a commercial lipid panel kit and Cholestech LDX analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean triglycerides (mg/dL) from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>Through finger prick blood collection, point of care tests will be used used to test triglycerides using a commercial lipid panel kit and Cholestech LDX analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes self-management behaviors from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>The Summary of Diabetes Self-Care Activities (SDSCA) will be used to measure engagement in self-management activities. The SDSCA consists of 12 items to assess the self-reported frequency of performing diabetes self-care tasks, including testing blood sugar, following healthful eating plans, and exercising regularly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes-related self-efficacy from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>The Diabetes Management Self-Efficacy Scale (DMSES) will be used to measure patient's confidence in managing their diabetes. The DMSES consists of 8 items to assess self-reported confidence in managing aspects of their diabetes. Items are scored on a 0-10 point scale, with higher scores indicating higher levels of self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes-related distress from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>The Problem Areas in Diabetes Scale (PAID)-5 will be used to measure diabetes distress. The PAID-5 consists of 5 items to assess self-reported diabetes-related emotional distress, including feeling scared or depressed. Items are scored on a 0-4 point scale, with higher scores indicating higher levels of distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes-related quality of life from baseline to 12 weeks post-intervention</measure>
    <time_frame>Baseline and 12 weeks post-intervention</time_frame>
    <description>The DAWN2 Impact of Diabetes Profile (DIDP) will be used to measure the perceived impact of diabetes on patients' quality of life. The DIDP consists of 6 items to assess self-reported impacts on quality of life, including physical health, financial situation, and relationships with others.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Sleep Hygiene</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)</intervention_name>
    <description>SHES outlines the importance of sleep for people with type 2 diabetes mellitus and provide practical information and guidance about sleep habits. Specifically, the focus will be on: avoiding consumption of caffeine, nicotine, alcohol; avoiding use of light emitting devices before bedtime; avoiding excessive intake of fluids or heavy meals before bedtime; promoting regulation of light, noise, and temperature in the bedroom; timing of and importance of exercise; maintaining consistent sleep and wake times; establishing a pre-bedtime routine; and managing stress.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes&#xD;
&#xD;
          -  Speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received DSME in the past three years&#xD;
&#xD;
          -  Have a condition that makes it unlikely they will be able to follow the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences Northwest</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04420845
org study id: 239740
nct id: NCT04420845
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will test whether adding sleep hygiene education and support to diabetes
      self-management education and support (DSMES) in diverse patients (African American,
      Hispanic, Pacific Islander, and Caucasian) with type 2 diabetes myelitis (T2DM) from rural
      UAMS Regional Programs clinics is more effective than DSMES alone. The specific aims for this
      study are:

        -  Aim 1A (Primary): Determine if this model improves blood glucose levels as measured by
           the HbA1c test in diverse adults with T2DM.

        -  Aim 1B: Determine the preliminary effectiveness of DSMES+SHES on sleep duration and
           sleep quality, blood pressure, fasting lipids, body mass index (BMI), self-management
           behavior, self-efficacy, diabetes-related distress, and diabetes-related quality of life
           in diverse adults with T2DM.

        -  Aim 2A: Determine the feasibility and acceptability of DSMES+ SHES when implemented with
           diverse adults with T2DM.

        -  Aim 2B: Determine the feasibility and acceptability of DSMES+ SHES implementation in
           Regional Programs clinics.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in mean HbA1c (NGSP%) from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: A Siemens analyzer will be utilized to calculate HbA1c (%) for each participant at each time point. Changes in the primary outcome measure will be assessed from baseline to post-intervention.
measure: Change in sleep duration from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: Self-reported sleep duration (hours slept) will be assessed using valid Behavioral Risk Factor Surveillance System survey items.
measure: Change in sleep quality from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: The PROMIS® Short Form v1.0- Sleep Disturbance-4a scale will be used to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep.
measure: Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: Blood pressure will be measured with a sphygmomanometer and stethoscope or digital blood pressure device with the participant seated and arm elevated.
measure: Change in mean body mass index (BMI) from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: BMI will be collected by measuring participant height (without shoes) using a stadiometer, and by measuring participant weight (without shoes) using a calibrated digital scale. Participant weight and height will then be used to compute a continuous measure of BMI.
measure: Change in mean total cholesterol (mg/dL) from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: Through finger prick blood collection, point of care tests will be used used to test total cholesterol using a commercial lipid panel kit and Cholestech LDX analyzer.
measure: Change in mean low-density lipoproteins (LDL) (mg/dL) from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: Through finger prick blood collection, point of care tests will be used used to test LDL using a commercial lipid panel kit and Cholestech LDX analyzer.
measure: Change in mean high-density lipoproteins (HDL) (mg/dL) from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: Through finger prick blood collection, point of care tests will be used used to test HDL using a commercial lipid panel kit and Cholestech LDX analyzer.
measure: Change in mean triglycerides (mg/dL) from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: Through finger prick blood collection, point of care tests will be used used to test triglycerides using a commercial lipid panel kit and Cholestech LDX analyzer.
measure: Change in diabetes self-management behaviors from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: The Summary of Diabetes Self-Care Activities (SDSCA) will be used to measure engagement in self-management activities. The SDSCA consists of 12 items to assess the self-reported frequency of performing diabetes self-care tasks, including testing blood sugar, following healthful eating plans, and exercising regularly.
measure: Change in diabetes-related self-efficacy from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: The Diabetes Management Self-Efficacy Scale (DMSES) will be used to measure patient's confidence in managing their diabetes. The DMSES consists of 8 items to assess self-reported confidence in managing aspects of their diabetes. Items are scored on a 0-10 point scale, with higher scores indicating higher levels of self-efficacy.
measure: Change in diabetes-related distress from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: The Problem Areas in Diabetes Scale (PAID)-5 will be used to measure diabetes distress. The PAID-5 consists of 5 items to assess self-reported diabetes-related emotional distress, including feeling scared or depressed. Items are scored on a 0-4 point scale, with higher scores indicating higher levels of distress.
measure: Change in diabetes-related quality of life from baseline to 12 weeks post-intervention
time frame: Baseline and 12 weeks post-intervention
description: The DAWN2 Impact of Diabetes Profile (DIDP) will be used to measure the perceived impact of diabetes on patients' quality of life. The DIDP consists of 6 items to assess self-reported impacts on quality of life, including physical health, financial situation, and relationships with others.
arm group label: Intervention
arm group type: Other
intervention type: Behavioral
intervention name: Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)
description: SHES outlines the importance of sleep for people with type 2 diabetes mellitus and provide practical information and guidance about sleep habits. Specifically, the focus will be on: avoiding consumption of caffeine, nicotine, alcohol; avoiding use of light emitting devices before bedtime; avoiding excessive intake of fluids or heavy meals before bedtime; promoting regulation of light, noise, and temperature in the bedroom; timing of and importance of exercise; maintaining consistent sleep and wake times; establishing a pre-bedtime routine; and managing stress.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No