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Clinical Trials/NCT02240082
NCT02240082
Unknown
Not Applicable

COPing With Shift Work

ISA Associates, Inc.1 site in 1 country300 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disorders
Sponsor
ISA Associates, Inc.
Enrollment
300
Locations
1
Primary Endpoint
Change in Pittsburgh Sleep Quality Index at 3 months
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
February 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Police officer with participating Police Departments
  • Access to a computer or mobile device with Internet access

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Pittsburgh Sleep Quality Index at 3 months

Time Frame: Baseline and Three-Month Follow UP

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

Time Frame: Baseline and Three Month Follow

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

Time Frame: Baseline and Three Month Follow Up

Based on the Mayo Clinic Nutrition and Healthy Eating questions, this measure ask how much caffeinated beverage the person consumes per day.

Secondary Outcomes

  • Change in Attitudes Towards a Healthy Diet at 3 months(Baseline and Three Month Follow Up)
  • Change in Godin Leisure-Time Exercise Questionnaire at 3 months(Baseline and Three Month Follow Up)
  • Change in Eating Patterns at 3 months(Baseline and Three Month Follow Up)
  • Change in Fat-Related Diet Habits at 3 months(Baseline and Three Month Follow Up)
  • Change in Work Limitations Questionnaire at 3 months(Baseline and Three Month Follow Up)

Study Sites (1)

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