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Characterizing Fatigue Experienced by Registered Nurses

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ClinicalTrials.gov Identifier: NCT03789188
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

Nursing is a high-stress job. It can be physically and mentally taxing. Nurses can have health problems due to long work hours, stressful work environments, and shift work. Fatigue is common among registered nurses (RNs). It has been linked with job burnout, missing work, injuries at work, and reduced job performance. Fatigue in RNs has been studied, but researchers want to learn more about it.

Objectives:

To learn more about how fatigue affects registered nurses.

Eligibility:

RNs at least 18 years old who work at NIH

Design:

Part 1: All RNs at the NIH will be invited to participate in an anonymous online survey. They will answer questions about their jobs and fatigue.

Part 2: Fatigue levels in a small group of RNs will be evaluated more closely. They will be screened with questions by phone or in person. They will be asked about their work schedule, ability to speak and read English, and general health.

Participants in Part 2 of the study will have 3 study visits.

-Visit 1 will be at least 48 hours after the last time the participant worked. Participants will fast before the visit. They will have a medical history, physical exam, and blood tests. They will receive a food diary and a sleep watch and diary. They will wear the watch and complete the diaries for 1 week.

Participants will answer questions on an iPad 2 times a day for 4 days. The first day will be when they complete visit 1. They then will do this for 3 workdays in a row. This will be right before and after work on those days. Questions will test their thinking and ask about their feelings.

  • Visit 2 will be right after finishing 3 work days in a row. Participants will have blood pressure and blood samples taken.
  • Visit 3 will be 1 week after finishing the diaries. Participants will return the sleep watch, iPad, and diaries A dietician may ask them questions about the food diary.

Condition or disease
Fatigue

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 460 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Characterizing Fatigue Experienced by Registered Nurses
Estimated Study Start Date : November 20, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Group/Cohort
Healthy Volunteers
CC Registered Nurses



Primary Outcome Measures :
  1. Fatigue - as measured by the Multidimensional Fatigue Symptom Inventory (MFSI) and the Occupational Fatigue Exhaustion Recovery Scale (OFER) [ Time Frame: In Phase I = cross sectional only; Phase II: Baseline, Workday 1 (beginning and end of shift) Workday 2 (beginning and end of shift), Workday 3 (beginning and end of the shift) ]
    Total and subscale score for the MFSI and OFER. These measures will be used to describe levels of fatigue in RNs, and to identify factors that contribute to fatigue in RNs


Secondary Outcome Measures :
  1. (Exploratory outcome) Clinical factors/Biomarkers associated with fatigue [ Time Frame: Phase II: Baseline and workday yhree (end of shift) ]
    Exploratory biomarkers potentially related to fatigue that will be examined will include orthostatic blood pressure (measure of autonomic function) and inflammatory biomarkers (hs-CRP, TNF-, IL-6, IL1-beta, and GlycA)

  2. "Performance" outcomes associated with fatigue: cognitive performance, mood, and quality of life. See Secondary Outcome description for more details. [ Time Frame: In Phase I + cross sectional only; Phase II: Baseline, Workday 1 (beginning and end of shift) Workday 2 (beginning and end of shift), Workday 3 (beginning and end of the shift) ]
    Secondary Outome: "Performance" outcomes associated with fatigue: cognitive performance (NIH toolbox measures of cognitive performance), mood (Profile of Mood States Questionnaire), and quality of life (PROMIS questionnaires of life satisfaction and the abilityto fulfill social roles/activities.These performance measures are questionnaires designed to collect information about downstream outcomes that are known to be associated with fatigue



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
registered nurses working in the National Institutes of Health Clinical Center
Criteria
  • INCLUSION CRITERIA:

Phase I

  • CCND credentialed RN
  • Age > 18 years old
  • Able to read and speak English
  • Agrees to participate in the study
  • Ability to complete online surveys

Phase II

  • CCND credentialed RN employed full time
  • Age > 18 years old
  • Able to read and speak English
  • Agrees to participate in the study

EXCLUSION CRITERIA:

Phase I

  • Age < 18 years old
  • Inability to comprehend investigational nature of study
  • Unable to read and speak English
  • Unable to complete online surveys

Phase II

  • Age < 18 years old
  • Inability to comprehend investigational nature of study
  • Known phobias or adverse reactions to blood draws
  • Inability to provide informed consent
  • Unable to read and speak English
  • Individuals with a disease or condition that causes fatigue (e.g. heart failure, multiple sclerosis, rheumatoid arthritis)
  • Individuals routinely taking prescription medicines that cause fatigue (e.g. beta blockers, narcotics)
  • Individuals taking prescription oral anti-inflammatory medications
  • Pregnant or lactating women
  • Member of the research team

Information from the National Library of Medicine

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): NCT03789188


Contacts
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Contact: Brenda D Roberson, R.N. (301) 594-5321 broberson@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Alyson C. Ross, R.N. National Institutes of Health Clinical Center (CC)

Additional Information:
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT03789188     History of Changes
Other Study ID Numbers: 190035
19-CC-0035
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: April 26, 2019
Keywords provided by National Institutes of Health Clinical Center (CC):
Inflammation
Nutrition
Shift Work
Sleep
Cognitive Performance
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms