COPing With Shift Work - Web Based Program for Police Officers

NCT02240082 | Unknown

• 2 other identifiers: HL1141855R44HL114185
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders; Stress

Keywords

Shiftwork; Sleep disruption; Stress

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and Three-Month Follow UP

• 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."

  Baseline and Three Month Follow

• 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.

  Baseline and Three Month Follow Up

Secondary Outcomes (5)

• 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 Arms (2)

Web-based COPing with Shiftwork Program

EXPERIMENTAL

Participants in this condition will use the web-based COPing with Shiftwork web-based program for three months

Behavioral: Web-Based COPing with Shiftwork Program

Wait List Control

NO INTERVENTION

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.

Interventions

Web-Based COPing with Shiftwork Program BEHAVIORAL

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

Web-based COPing with Shiftwork Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• ISA Associates, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

ISA Associates, Inc

Alexandria, Virginia, 22304, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rebekah K Hersch, Ph.D.

  ISA Associates, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 15, 2014
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

US (1)