The Effects of Work Schedule and Sleep Patterns on Caregivers' Health

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jackilen Shannon, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01443156
First received: September 20, 2011
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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
Obesity
Diabetes
Cancer
Metabolic Syndrome
Sleep Deprivation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Cognitive performance [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Brief computerized tasks of attention, vigilance, and memory.

  • Body Composition [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Height, weight, waist circumference, body fat percentage, body mass index

  • Diet [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Brief computerized survey on fruit, vegetable, and fat intake.

  • Work Schedule [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Survey on the quantity and distribution of work hours.


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Blood cholesterol, glucose, triglycerides [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Fingerstick test

  • Breast, skin, and lung cancer prevention behaviors and knowledge [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Brief computerized questionnaires.

  • Preventive care habits [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Brief survey on basic health behaviors and use of preventive care resources.


Biospecimen Retention:   Samples With DNA

Mouthwash swish containing buccal cells.


Enrollment: 211
Study Start Date: January 2012
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Caregivers
Employees at a local medical facility, including (but not limited to): nurses, laboratory technicians, non-clinical hospital staff

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cohort participants will be recruited from employees at a local health care center. Job categories may include, but are not limited to:

  • Administrative services
  • Clinical services (radiology, laboratory, pharmacy, etc.)
  • Clinical support services (aide, clerk, processing, records, etc.)
  • Practitioner (physician, physician assistant, nurse practitioner, etc.)
  • Non-clinical services (food, nutrition, housekeeping, etc.)
  • Nursing services—registered nurse
  • Nursing services—certified nursing assistant
  • Rehabilitative services (occupational therapy, speech therapy, physical therapy, etc.)
Criteria

Inclusion Criteria:

  • Employed caregiver in a hospital setting
  • 18 years of age or older
  • Completion of minimal set of stations (see below, section III.d.)
  • Consent given electronically

Exclusion Criteria:

  • Declining to consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443156

Locations
United States, Oregon
St. Charles Medical Center
Bend, Oregon, United States, 97701
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Jackilen Shannon, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Jackilen Shannon, Scientist, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01443156     History of Changes
Other Study ID Numbers: OHSU eIRB7542
Study First Received: September 20, 2011
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Diet
Sleep deficiency
Cancer
Obesity
Diabetes
Shift work
Work schedule
Cardiovascular disease
Body composition
Body mass index
Body fat percentage

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Sleep Deprivation
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on April 16, 2014