<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/NCT02240082</url>
  </required_header>
  <id_info>
    <org_study_id>HL114185</org_study_id>
    <secondary_id>5R44HL114185</secondary_id>
    <nct_id>NCT02240082</nct_id>
  </id_info>
  <brief_title>COPing With Shift Work - Web Based Program for Police Officers</brief_title>
  <official_title>COPing With Shift Work</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ISA Associates, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>ISA Associates, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a clinical trial in which 300 Police Officers who currently work midnight&#xD;
      shifts in the participating police departments will be recruited to test the effectiveness of&#xD;
      a new web-based program to address sleep and associated problems related to shift work,&#xD;
      particularly night shift work. Recruitment letters will be sent to all officers currently&#xD;
      working midnight shift, with the goal of recruiting 300 officers willing to participate in&#xD;
      the study. The 300 participants will be randomly assigned to either the experimental group&#xD;
      (receiving the web-based program) or the waitlist control group. Participants in the&#xD;
      experimental group will be given access to the program site (COPing with Shift Work) and the&#xD;
      mobile application (Sleep Tracker). Following completion of the field test, participants in&#xD;
      the control condition (as well as all other interested officers) will have access to the&#xD;
      web-based COPing with Shift Work program.&#xD;
&#xD;
      All participants will be asked to complete a baseline questionnaire containing multiple&#xD;
      measures of sleep, dietary practices, physical activity and job performance. Participants&#xD;
      will be asked to complete the posttest approximately three months following initial access to&#xD;
      the intervention.&#xD;
&#xD;
      Primary and secondary outcome measures: The Primary outcome measures are &quot;sleep quality&quot; as&#xD;
      measured by the Pittsburgh Sleep Quality Index (PSQI) and &quot;sleepiness&quot; as measured by the&#xD;
      sleepiness subscale of the widely used Karolinska Sleep Questionnaire (KSQ). The&#xD;
      investigators have adapted the sleep measures to apply to individuals who work nights and may&#xD;
      sleep during the day.&#xD;
&#xD;
      Secondary outcome measures include the Nutritional Patterns Scale, a 13-item modification of&#xD;
      the Block Self-Administered Diet History Questionnaire assessing the nutritional value of the&#xD;
      respondent's diet; Attitudes Toward a Healthy Diet, a 17-item scale, based on the Health&#xD;
      Belief Model and developed and validated by Trenkner and associates assessing perceived&#xD;
      benefits and barriers to eating a healthy diet; the Godin Leisure-Time Exercise&#xD;
      Questionnaire, a brief 4-item query of usual leisure-time exercise habits; and work&#xD;
      productivity measured with the Work Limitations Questionnaire (WLQ), developed and validated&#xD;
      by Lerner and associates.&#xD;
&#xD;
      It is expected that the program group participants will have significantly better outcomes&#xD;
      than the control group at three months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">February 2016</completion_date>
  <primary_completion_date type="Anticipated">February 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pittsburgh Sleep Quality Index at 3 months</measure>
    <time_frame>Baseline and Three-Month Follow UP</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI) will be one of two central outcome measures. The PSQI is a widely used and well validated 19-item self-report instrument that measures sleep disturbance in adults. It includes 7 subscale scores (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medications, and daytime dysfunction), along with a global score ranging from no sleep difficulty to severe sleep difficulties.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Karolinska Sleep Questionnaire at 3 months</measure>
    <time_frame>Baseline and Three Month Follow</time_frame>
    <description>A second primary outcome measure will be the Sleepiness subscale of the widely used Karolinska Sleep Questionnaire. In contrast to the PSQI, which focuses on the quality of sleep, this measure focuses specifically on sleepiness during waking hours over the past 3 months. It is a 5-item scale (with a 1-6 response scale, where 1 = no problems and 6 = problems every day), assessing sleepiness at work, sleepiness during leisure time, involuntary dozing off at work, involuntary dozing during leisure time, and the &quot;need to fight sleep to stay awake.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Caffeine Beverage Consumption at 3 months</measure>
    <time_frame>Baseline and Three Month Follow Up</time_frame>
    <description>Based on the Mayo Clinic Nutrition and Healthy Eating questions, this measure ask how much caffeinated beverage the person consumes per day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Attitudes Towards a Healthy Diet at 3 months</measure>
    <time_frame>Baseline and Three Month Follow Up</time_frame>
    <description>This 17-item scale, based on the Health Belief Model and developed and validated by Trenkner and associates, assesses perceived benefits and barriers to eating a healthy diet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Godin Leisure-Time Exercise Questionnaire at 3 months</measure>
    <time_frame>Baseline and Three Month Follow Up</time_frame>
    <description>The Godin Leisure-Time Exercise Questionnaire is a brief 4-item query of usual leisure-time exercise habits. The first three items ask the respondent to indicate the times per week they engage in strenuous, moderate, and light activities. The fourth item asks how often in a typical 7-day period the respondent engages in activity long enough to work up a sweat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Eating Patterns at 3 months</measure>
    <time_frame>Baseline and Three Month Follow Up</time_frame>
    <description>The Eating Patterns Questionnaire includes 12 items answered using a 4-point Likert scale regarding the situations around eating such as &quot;How often do you eat too much?&quot; &quot;Do you have trouble controlling your eating when your favorite foods are in the house?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fat-Related Diet Habits at 3 months</measure>
    <time_frame>Baseline and Three Month Follow Up</time_frame>
    <description>The Fat-Related Diet Habits questionnaire was adapted from the Fred Hutchinson Cancer Research Center questionnaire for self-administration. The questions relate to how often the person consumes specific types of food.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Work Limitations Questionnaire at 3 months</measure>
    <time_frame>Baseline and Three Month Follow Up</time_frame>
    <description>Work productivity will be measured with the Work Limitations Questionnaire (WLQ), developed and validated by Lerner and associates. The WLQ contains four separate scales: a 5-item scale assessing difficulty meeting time and scheduling demands, a 6-item scale measuring a person's ability to perform job tasks involving strength, endurance, and flexibility, a 9-item scale assessing difficulty managing cognitive and interpersonal job demands, and a 5-item scale measuring a person's ability to keep up with the quality and quantity job demands.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Sleep Disorders</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Web-based COPing with Shiftwork Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will use the web-based COPing with Shiftwork web-based program for three months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the wait list control group will not receive any intervention during the study period, but will have access to any program offered by the police department.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web-Based COPing with Shiftwork Program</intervention_name>
    <description>COPing with Shift Work is an interactive, web-based program designed specifically for law enforcement officers to assist with the management of health and lifestyle challenges associated with shift work. The program will contain modules on sleep, physical activity, and nutrition in order to improve the health and safety of law enforcement officers and reduce their risk of chronic diseases associated with shift work. These modules will contain interactive assessments and cutting-edge scientific information on sleep, nutrition, and physical activity. Based on user input, officers will receive personalized feedback, tools, and strategies</description>
    <arm_group_label>Web-based COPing with Shiftwork Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Police officer with participating Police Departments&#xD;
&#xD;
          -  Access to a computer or mobile device with Internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>
  <overall_official>
    <last_name>Rebekah K Hersch, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>ISA Associates, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ISA Associates, Inc</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>October 26, 2015</last_update_submitted>
  <last_update_submitted_qc>October 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Shiftwork</keyword>
  <keyword>Sleep disruption</keyword>
  <keyword>Stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</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/NCT02240082
org study id: HL114185
secondary id: 5R44HL114185
nct id: NCT02240082
lead sponsor: 
collaborator: 
has dmc: No
This study is a clinical trial in which 300 Police Officers who currently work midnight
      shifts in the participating police departments will be recruited to test the effectiveness of
      a new web-based program to address sleep and associated problems related to shift work,
      particularly night shift work. Recruitment letters will be sent to all officers currently
      working midnight shift, with the goal of recruiting 300 officers willing to participate in
      the study. The 300 participants will be randomly assigned to either the experimental group
      (receiving the web-based program) or the waitlist control group. Participants in the
      experimental group will be given access to the program site (COPing with Shift Work) and the
      mobile application (Sleep Tracker). Following completion of the field test, participants in
      the control condition (as well as all other interested officers) will have access to the
      web-based COPing with Shift Work program.

      All participants will be asked to complete a baseline questionnaire containing multiple
      measures of sleep, dietary practices, physical activity and job performance. Participants
      will be asked to complete the posttest approximately three months following initial access to
      the intervention.

      Primary and secondary outcome measures: The Primary outcome measures are "sleep quality" as
      measured by the Pittsburgh Sleep Quality Index (PSQI) and "sleepiness" as measured by the
      sleepiness subscale of the widely used Karolinska Sleep Questionnaire (KSQ). The
      investigators have adapted the sleep measures to apply to individuals who work nights and may
      sleep during the day.

      Secondary outcome measures include the Nutritional Patterns Scale, a 13-item modification of
      the Block Self-Administered Diet History Questionnaire assessing the nutritional value of the
      respondent's diet; Attitudes Toward a Healthy Diet, a 17-item scale, based on the Health
      Belief Model and developed and validated by Trenkner and associates assessing perceived
      benefits and barriers to eating a healthy diet; the Godin Leisure-Time Exercise
      Questionnaire, a brief 4-item query of usual leisure-time exercise habits; and work
      productivity measured with the Work Limitations Questionnaire (WLQ), developed and validated
      by Lerner and associates.

      It is expected that the program group participants will have significantly better outcomes
      than the control group at three months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Pittsburgh Sleep Quality Index at 3 months
time frame: Baseline and Three-Month Follow UP
description: Pittsburgh Sleep Quality Index (PSQI) will be one of two central outcome measures. The PSQI is a widely used and well validated 19-item self-report instrument that measures sleep disturbance in adults. It includes 7 subscale scores (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medications, and daytime dysfunction), along with a global score ranging from no sleep difficulty to severe sleep difficulties.
measure: Change in Karolinska Sleep Questionnaire at 3 months
time frame: Baseline and Three Month Follow
description: A second primary outcome measure will be the Sleepiness subscale of the widely used Karolinska Sleep Questionnaire. In contrast to the PSQI, which focuses on the quality of sleep, this measure focuses specifically on sleepiness during waking hours over the past 3 months. It is a 5-item scale (with a 1-6 response scale, where 1 = no problems and 6 = problems every day), assessing sleepiness at work, sleepiness during leisure time, involuntary dozing off at work, involuntary dozing during leisure time, and the "need to fight sleep to stay awake."
measure: Change in Caffeine Beverage Consumption at 3 months
time frame: Baseline and Three Month Follow Up
description: Based on the Mayo Clinic Nutrition and Healthy Eating questions, this measure ask how much caffeinated beverage the person consumes per day.
measure: Change in Attitudes Towards a Healthy Diet at 3 months
time frame: Baseline and Three Month Follow Up
description: This 17-item scale, based on the Health Belief Model and developed and validated by Trenkner and associates, assesses perceived benefits and barriers to eating a healthy diet.
measure: Change in Godin Leisure-Time Exercise Questionnaire at 3 months
time frame: Baseline and Three Month Follow Up
description: The Godin Leisure-Time Exercise Questionnaire is a brief 4-item query of usual leisure-time exercise habits. The first three items ask the respondent to indicate the times per week they engage in strenuous, moderate, and light activities. The fourth item asks how often in a typical 7-day period the respondent engages in activity long enough to work up a sweat.
measure: Change in Eating Patterns at 3 months
time frame: Baseline and Three Month Follow Up
description: The Eating Patterns Questionnaire includes 12 items answered using a 4-point Likert scale regarding the situations around eating such as "How often do you eat too much?" "Do you have trouble controlling your eating when your favorite foods are in the house?"
measure: Change in Fat-Related Diet Habits at 3 months
time frame: Baseline and Three Month Follow Up
description: The Fat-Related Diet Habits questionnaire was adapted from the Fred Hutchinson Cancer Research Center questionnaire for self-administration. The questions relate to how often the person consumes specific types of food.
measure: Change in Work Limitations Questionnaire at 3 months
time frame: Baseline and Three Month Follow Up
description: Work productivity will be measured with the Work Limitations Questionnaire (WLQ), developed and validated by Lerner and associates. The WLQ contains four separate scales: a 5-item scale assessing difficulty meeting time and scheduling demands, a 6-item scale measuring a person's ability to perform job tasks involving strength, endurance, and flexibility, a 9-item scale assessing difficulty managing cognitive and interpersonal job demands, and a 5-item scale measuring a person's ability to keep up with the quality and quantity job demands.
arm group label: Web-based COPing with Shiftwork Program
arm group type: Experimental
description: Participants in this condition will use the web-based COPing with Shiftwork web-based program for three months
arm group label: Wait List Control
arm group type: No Intervention
description: Participants in the wait list control group will not receive any intervention during the study period, but will have access to any program offered by the police department.
intervention type: Behavioral
intervention name: Web-Based COPing with Shiftwork Program
description: COPing with Shift Work is an interactive, web-based program designed specifically for law enforcement officers to assist with the management of health and lifestyle challenges associated with shift work. The program will contain modules on sleep, physical activity, and nutrition in order to improve the health and safety of law enforcement officers and reduce their risk of chronic diseases associated with shift work. These modules will contain interactive assessments and cutting-edge scientific information on sleep, nutrition, and physical activity. Based on user input, officers will receive personalized feedback, tools, and strategies
arm group label: Web-based COPing with Shiftwork Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rebekah K Hersch, Ph.D.
role: Principal Investigator
affiliation: ISA Associates, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Wake Disorders