COPing With Shift Work - Web Based Program for Police Officers
Primary Purpose
Sleep Disorders, Stress
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-Based COPing with Shiftwork Program
Sponsored by
About this trial
This is an interventional prevention trial for Sleep Disorders focused on measuring Shiftwork, Sleep disruption, Stress
Eligibility Criteria
Inclusion Criteria:
- Police officer with participating Police Departments
- Access to a computer or mobile device with Internet access
Exclusion Criteria:
- None
Sites / Locations
- ISA Associates, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Web-based COPing with Shiftwork Program
Wait List Control
Arm Description
Participants in this condition will use the web-based COPing with Shiftwork web-based program for three months
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.
Outcomes
Primary Outcome Measures
Change in Pittsburgh Sleep Quality Index at 3 months
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.
Change in Karolinska Sleep Questionnaire at 3 months
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."
Change in Caffeine Beverage Consumption at 3 months
Based on the Mayo Clinic Nutrition and Healthy Eating questions, this measure ask how much caffeinated beverage the person consumes per day.
Secondary Outcome Measures
Change in Attitudes Towards a Healthy Diet at 3 months
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.
Change in Godin Leisure-Time Exercise Questionnaire at 3 months
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.
Change in Eating Patterns at 3 months
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?"
Change in Fat-Related Diet Habits at 3 months
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.
Change in Work Limitations Questionnaire at 3 months
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.
Full Information
NCT ID
NCT02240082
First Posted
September 10, 2014
Last Updated
October 26, 2015
Sponsor
ISA Associates, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02240082
Brief Title
COPing With Shift Work - Web Based Program for Police Officers
Official Title
COPing With Shift Work
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ISA Associates, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Stress
Keywords
Shiftwork, Sleep disruption, Stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Web-based COPing with Shiftwork Program
Arm Type
Experimental
Arm Description
Participants in this condition will use the web-based COPing with Shiftwork web-based program for three months
Arm Title
Wait List Control
Arm Type
No Intervention
Arm 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(s)
Web-Based COPing with Shiftwork Program
Intervention 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
Primary Outcome Measure Information:
Title
Change in Pittsburgh Sleep Quality Index at 3 months
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.
Time Frame
Baseline and Three-Month Follow UP
Title
Change in Karolinska Sleep Questionnaire at 3 months
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."
Time Frame
Baseline and Three Month Follow
Title
Change in Caffeine Beverage Consumption at 3 months
Description
Based on the Mayo Clinic Nutrition and Healthy Eating questions, this measure ask how much caffeinated beverage the person consumes per day.
Time Frame
Baseline and Three Month Follow Up
Secondary Outcome Measure Information:
Title
Change in Attitudes Towards a Healthy Diet at 3 months
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.
Time Frame
Baseline and Three Month Follow Up
Title
Change in Godin Leisure-Time Exercise Questionnaire at 3 months
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.
Time Frame
Baseline and Three Month Follow Up
Title
Change in Eating Patterns at 3 months
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?"
Time Frame
Baseline and Three Month Follow Up
Title
Change in Fat-Related Diet Habits at 3 months
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.
Time Frame
Baseline and Three Month Follow Up
Title
Change in Work Limitations Questionnaire at 3 months
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.
Time Frame
Baseline and Three Month Follow Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Police officer with participating Police Departments
Access to a computer or mobile device with Internet access
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebekah K Hersch, Ph.D.
Organizational Affiliation
ISA Associates, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
ISA Associates, Inc
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
COPing With Shift Work - Web Based Program for Police Officers
We'll reach out to this number within 24 hrs