Sleep DisordersNCT02240082
COPing With Shift Work - Web Based Program for Police Officers
A study testing Web-Based COPing with Shiftwork Program in people with Sleep Disorders and Stress, run by ISA Associates, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Stress
- What is being tested?
- Web-Based COPing with Shiftwork Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Police officer with participating Police Departments
- Access to a computer or mobile device with Internet access
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COPing With Shift Work
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.
Read more
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
- Being tested
- Web-Based COPing with Shiftwork Program
- Keywords
- Shiftwork, Sleep disruption, Stress
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based COPing with Shiftwork ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: 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.
Measured: Baseline and Three Month Follow Up
Secondary outcomes (5)
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.
Measured: Baseline and Three Month Follow Up
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.
Measured: Baseline and Three Month Follow Up
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?"
Measured: Baseline and Three Month Follow Up
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.
Measured: Baseline and Three Month Follow Up
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.
Measured: Baseline and Three Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startMar 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISA Associates, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Rebekah K Hersch, Ph.D., Principal investigator, ISA Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240082
- Sponsor's protocol ID
- HL114185
- Other IDs
- 5R44HL114185
- Status last verified
- Oct 2015
- First submitted
- 10 Sep 2014
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPing With Shift Work
- ClinicalTrials.gov ID
- NCT02240082
- Acronym / sponsor ID
- HL114185
- Conditions
- Sleep Disorders, Stress
- Keywords
- Shiftwork, Sleep disruption, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ISA Associates, Inc.University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based COPing with Shiftwork Program | Experimental | Behavioral: Web-Based COPing with Shiftwork ProgramParticipants in this condition will use the web-based COPing with Shiftwork web-based program for three months |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Police officer with participating Police Departments
- Access to a computer or mobile device with Internet access
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based COPing with Shiftwork ProgramCOPing 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 | Behavioural | Web-based COPing with Shiftwork Program |
Primary outcome
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.
5 secondary outcomes
Change in Attitudes Towards a Healthy Diet at 3 months
Time frame: Baseline and Three Month Follow Up
Change in Godin Leisure-Time Exercise Questionnaire at 3 months
Time frame: Baseline and Three Month Follow Up
Change in Eating Patterns at 3 months
Time frame: Baseline and Three Month Follow Up
Change in Fat-Related Diet Habits at 3 months
Time frame: Baseline and Three Month Follow Up
Change in Work Limitations Questionnaire at 3 months
Time frame: Baseline and Three Month Follow Up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebekah K Hersch, Ph.D. principal investigator
ISA Associates, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based COPing with Shiftwork Program in people with Sleep Disorders and Stress, run by ISA Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index at 3 months (time frame: Baseline and Three-Month Follow UP). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.