The Effects of Work Schedule and Sleep Patterns on Caregivers' Health
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|ClinicalTrials.gov Identifier: NCT01443156|
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : February 18, 2013
BACKGROUND. Sleep deficiency (not getting enough sleep) is widespread in American adults and can lead to many harmful health outcomes such as a higher risk of obesity, heart disease, and diabetes. Sleep deficiency can also harm cognitive performance, which refers to one's awareness and thinking ability. Sleep deficiency and sleep-related health issues are of high interest among those who have irregular and/or extended work schedules, because such schedules can interfere with normal biological rhythms of sleepiness and wakefulness.
PURPOSE. This study will examine the health and cognitive effects of work schedule and sleep patterns in caregivers (such as nurses, laboratory technicians, and non-clinical hospital staff). The investigators hypothesize that the nontraditional, irregular, and extended work hours common in these professions will have adverse health and cognitive effects. The purposes of this protocol are to:
- Enroll caregivers into a one year cohort study on the relationships among work schedule, sleep, diet, chronic disease, and cognitive performance. (A cohort study follows a group of participants over time to see how different behaviors or risk factors affect health.)
- Collect data from caregivers on work schedule, sleep, diet, chronic disease, and cognitive performance.
- Give personalized information and feedback to caregivers about these health factors.
- Educate caregivers about healthy diet and exercise choices.
- Collect saliva from caregivers for future research on the role of genes in health. (Specimen collection for genetic testing will be offered as a separate option for study participants.) RECRUITMENT. This study will use the Let's Get Healthy! health research and education program (OHSU IRB #3694) as a platform for recruitment and data collection. Caregivers will be invited to participate in a Let's Get Healthy! event and will be given information prior to the event about the cohort study. At the Let's Get Healthy! event, caregivers will first consent to the anonymous research study (OHSU IRB #3694), in which demographic and health screening data are linked to a random number. Caregivers will then have the option to consent to a cohort study, in which data are no longer anonymous but instead linked to participants' names and contact information.
PROCEDURES. This cohort study piggybacks on procedures already approved for the Let's Get Healthy! program (OHSU IRB #3694). Let's Get Healthy! is a study in which participants provide anonymous data at health fairs through any or all of the following manners: short computer surveys on cancer awareness, risk factors, and family history (with immediate feedback given on cancer risk and prevention); short computer surveys on diet and sleep patterns (with immediate printed feedback given); health screening measurements (blood pressure, height, weight, waist circumference, body mass index, body fat percentage); a finger stick to assess sugar and fat levels in blood; and a mouthwash swish to provide a saliva specimen.
However, this cohort study (OHSU IRB #7542) will make the following changes and additions:
- Personal health data, instead of being anonymous, will be linked to participants' names and contact information (for follow-up data collection).
- Let's Get Healthy! events will include cognitive performance tests, a preventative-care survey, and a work schedule survey.
- Participants will provide data not only at an initial Let's Get Healthy! event, but also at a follow-up event and during the time period between events. Between events, participants will do the surveys on work schedule, diet, and sleep, and they will complete cognitive performance tests.
- There will be a separate consent process for participants to provide a fully identifiable saliva specimen.
DATA ANALYSIS. Participants' health data will be fully identifiable at the time of data collection but will be coded and stored in a physically separate location from the identifiable information. The link between identifiable information and coded health information will be stored on a password protected computer, and all identifiable information will be deleted upon completion of data analyses. Data will be analyzed to explore relationships among work schedule, sleep, diet, body composition, metabolic health, chronic disease, and cognitive performance in caregivers. Genetic relationships with these factors will be analyzed in those who provided a saliva specimen during entry visit data collection.
|Condition or disease|
|Obesity Diabetes Cancer Metabolic Syndrome Sleep Deprivation|
|Study Type :||Observational|
|Actual Enrollment :||211 participants|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||February 2013|
Employees at a local medical facility, including (but not limited to): nurses, laboratory technicians, non-clinical hospital staff
- Cognitive performance [ Time Frame: Up to one year ]Brief computerized tasks of attention, vigilance, and memory.
- Body Composition [ Time Frame: Up to one year ]Height, weight, waist circumference, body fat percentage, body mass index
- Diet [ Time Frame: Up to one year ]Brief computerized survey on fruit, vegetable, and fat intake.
- Work Schedule [ Time Frame: Up to one year ]Survey on the quantity and distribution of work hours.
- Blood Pressure [ Time Frame: Up to one year ]
- Blood cholesterol, glucose, triglycerides [ Time Frame: Up to one year ]Fingerstick test
- Breast, skin, and lung cancer prevention behaviors and knowledge [ Time Frame: Up to one year ]Brief computerized questionnaires.
- Preventive care habits [ Time Frame: Up to one year ]Brief survey on basic health behaviors and use of preventive care resources.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443156
|United States, Oregon|
|St. Charles Medical Center|
|Bend, Oregon, United States, 97701|
|Principal Investigator:||Jackilen Shannon, PhD||Oregon Health and Science University|