<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03789188</url>
  </required_header>
  <id_info>
    <org_study_id>190035</org_study_id>
    <secondary_id>19-CC-0035</secondary_id>
    <nct_id>NCT03789188</nct_id>
  </id_info>
  <brief_title>Characterizing Fatigue Experienced by Registered Nurses</brief_title>
  <official_title>Characterizing Fatigue Experienced by Registered Nurses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Nursing is a high-stress job. It can be physically and mentally taxing. Nurses can have&#xD;
      health problems due to long work hours, stressful work environments, and shift work. Fatigue&#xD;
      is common among registered nurses (RNs). It has been linked with job burnout, missing work,&#xD;
      injuries at work, and reduced job performance. Fatigue in RNs has been studied, but&#xD;
      researchers want to learn more about it.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To learn more about how fatigue affects registered nurses.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      RNs at least 18 years old who work at NIH&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Part 1: All RNs at the NIH will be invited to participate in an anonymous online survey. They&#xD;
      will answer questions about their jobs and fatigue.&#xD;
&#xD;
      Part 2: Fatigue levels in a small group of RNs will be evaluated more closely. They will be&#xD;
      screened with questions by phone or in person. They will be asked about their work schedule,&#xD;
      ability to speak and read English, and general health.&#xD;
&#xD;
      Participants in Part 2 of the study will have 3 study visits.&#xD;
&#xD;
      -Visit 1 will be at least 48 hours after the last time the participant worked. Participants&#xD;
      will fast before the visit. They will have a medical history, physical exam, and blood tests.&#xD;
      They will receive a food diary and a sleep watch and diary. They will wear the watch and&#xD;
      complete the diaries for 1 week.&#xD;
&#xD;
      Participants will answer questions on an iPad 2 times a day for 4 days. The first day will be&#xD;
      when they complete visit 1. They then will do this for 3 workdays in a row. This will be&#xD;
      right before and after work on those days. Questions will test their thinking and ask about&#xD;
      their feelings.&#xD;
&#xD;
        -  Visit 2 will be right after finishing 3 work days in a row. Participants will have blood&#xD;
           pressure and blood samples taken.&#xD;
&#xD;
        -  Visit 3 will be 1 week after finishing the diaries. Participants will return the sleep&#xD;
           watch, iPad, and diaries A dietician may ask them questions about the food diary.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The U.S. health care system requires critical nursing services around the clock,&#xD;
      resulting in many nurses working overnight hours and having irregular shifts. One symptom&#xD;
      commonly associated with the nursing workplace is fatigue, affecting up to 80% of Registered&#xD;
      Nurses (RNs). Fatigue is problematic for RNs because it is associated with burnout,&#xD;
      absenteeism, job-related injury and reduced job performance. Factors&#xD;
&#xD;
      known to contribute to fatigue are physiological (e.g. sleep disturbances, physical health&#xD;
      and nutritional deficiencies), psychological (e.g. depression, anxiety, coping style), and&#xD;
      situational (e.g. shiftwork and high work demands). Fatigue in turn negatively affects&#xD;
      cognitive performance including memory, attention, and reaction time, as well as mood and&#xD;
      quality of life. The pathophysiological mechanisms underlying fatigue are complex and not&#xD;
      well understood. Hypothesized pathways include inflammation and autonomic dysregulation. The&#xD;
      specific physiological, psychological and situational factors contributing to fatigue in RNs&#xD;
      are unclear. Most studies in nurses look at fatigue in general, with few examining specific&#xD;
      subtypes such as mental, physical, and emotional fatigue. Very few studies have examined&#xD;
      fatigue in RNs longitudinally, nor have they explored the underlying pathophysiology. Little&#xD;
      is known about the downstream effects of fatigue on nurses cognitive performance or on their&#xD;
      ability to enjoy and participate in life outside of work. Thus, the objective of this study&#xD;
      is to characterize fatigue experienced by RNs and to examine the physiologic, psychologic,&#xD;
      and situational factors that contribute to fatigue and its subtypes.&#xD;
&#xD;
      AIMS: The primary AIM is to characterize the levels and types of fatigue experienced by RNs,&#xD;
      and to examine the physiologic, psychologic and situational factors contributing to fatigue&#xD;
      and its subtypes in RNs. The secondary AIM is to examine the relationship between fatigue&#xD;
      with cognitive performance, mood, life satisfaction, and the ability to participate in social&#xD;
      roles/activities in RNs and to assess changes in cognitive performance and mood over the&#xD;
      course of three working days. The exploratory AIM is to explore molecular and clinical&#xD;
      biomarkers associated with fatigue in a subset of RNs.&#xD;
&#xD;
      Study population: This study will occur in two parts. Phase I will recruit from a pool of&#xD;
      approximately 1,275 RNs at the NIH Clinical Center, and we anticipate that 400 RNs will&#xD;
      participate. Phase II will enroll up to 60 RNs, in order to obtain 40 RNs who complete all&#xD;
      study timepoints.&#xD;
&#xD;
      Design: This study will utilize an adaptive design whereby a preliminary, anonymous&#xD;
      cross-sectional surveyinvolving a large cohort of RNs will address the primary and secondary&#xD;
      AIMs (Phase I). Phase II will utilize a prospective, repeated measures design to collect&#xD;
      biomarkers of fatigue and health, along with more detailed psychologic, situational, and&#xD;
      performance outcomes in a small subset of RNs (n = 40) at multiple time points including&#xD;
      baseline (48+ hours after last working) and at the start and conclusion of three consecutive&#xD;
      workdays. Phase II will address the primary and secondary AIMS in greater depth and over&#xD;
      time, while addressing the exploratory AIMs of the study.&#xD;
&#xD;
      Outcome measures: The primary outcome is fatigue, using the Multidimensional Fatigue Symptom&#xD;
      Inventory- Short Form (MFSI-SF) and Occupational Fatigue Exhaustion Recovery (OFER) scale&#xD;
      used to: (1) determine the levels and types (general, physical, emotional, mental, acute and&#xD;
      chronic) of fatigue experienced by RNs (Phase I), (2) examine whether fatigue and its&#xD;
      subtypes change over time (Phase II); and (3) determine which physiologic (sleep disturbance,&#xD;
      physical health, nutritional status), psychologic (depression, anxiety, self-efficacy, coping&#xD;
      style), and situational (job type, work hours, work demands, professional quality of life,&#xD;
      outside demands) factors contribute to fatigue in RNs. Secondary outcomes include downstream&#xD;
      performance outcomes believed to be related to fatigue including NIH toolbox measures of&#xD;
      cognitive performance, Profile of Mood States (POMS), and PROMIS measures of life&#xD;
      satisfaction and the ability to perform social roles/activities. Exploratory factors that&#xD;
      potentially influence fatigue (MFSI-SF) will be examined in Phase II including markers of&#xD;
      autonomic function (orthostatic blood pressure (BP) and inflammation (hs-CRP, TNF-alpha,&#xD;
      IL-6, IL1-beta, and GlycA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator left NIH&#xD;
  </why_stopped>
  <start_date type="Actual">April 29, 2019</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 22, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue - as measured by the Multidimensional Fatigue Symptom Inventory (MFSI) and the Occupational Fatigue Exhaustion Recovery Scale (OFER)</measure>
    <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 shift)</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>(Exploratory outcome) Clinical factors/Biomarkers associated with fatigue</measure>
    <time_frame>Phase II: Baseline and Workday three (end of shift)</time_frame>
    <description>Exploratory biomarkers potentially related to fatigue that will be examined include orthostatic blood pressure (measure of autonomic function) and inflammatory biomarkers (hs-CRP, TNF-?, IL-6, IL1-(SqrRoot) , and GlycA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Performance&quot; 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 ability t...</measure>
    <time_frame>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 shift)</time_frame>
    <description>These performance measures are questionnaires designed to collect information about downstream outcomes that are known to be associated with fatigue</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">313</enrollment>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>CC Registered Nurses</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        registered nurses working in the National Institutes of Health Clinical Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Phase I&#xD;
&#xD;
          -  CCND credentialed RN&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Agrees to participate in the study&#xD;
&#xD;
          -  Ability to complete online surveys&#xD;
&#xD;
        Phase II&#xD;
&#xD;
          -  CCND credentialed RN employed full time&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Agrees to participate in the study&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        Phase I&#xD;
&#xD;
          -  Age &lt; 18 years old&#xD;
&#xD;
          -  Inability to comprehend investigational nature of study&#xD;
&#xD;
          -  Unable to read and speak English&#xD;
&#xD;
          -  Unable to complete online surveys&#xD;
&#xD;
        Phase II&#xD;
&#xD;
          -  Age &lt; 18 years old&#xD;
&#xD;
          -  Inability to comprehend investigational nature of study&#xD;
&#xD;
          -  Known phobias or adverse reactions to blood draws&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Unable to read and speak English&#xD;
&#xD;
          -  Individuals with a disease or condition that causes fatigue (e.g. heart failure,&#xD;
             multiple sclerosis, rheumatoid arthritis)&#xD;
&#xD;
          -  Individuals routinely taking prescription medicines that cause fatigue (e.g. beta&#xD;
             blockers, narcotics)&#xD;
&#xD;
          -  Individuals taking prescription oral anti-inflammatory medications&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Member of the research team&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alyson C. Ross, R.N.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institutes of Health Clinical Center (CC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-CC-0035.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Caruso CC, Baldwin CM, Berger A, Chasens ER, Landis C, Redeker NS, Scott LD, Trinkoff A. Position statement: Reducing fatigue associated with sleep deficiency and work hours in nurses. Nurs Outlook. 2017 Nov-Dec;65(6):766-768. doi: 10.1016/j.outlook.2017.10.011. No abstract available.</citation>
    <PMID>29216975</PMID>
  </reference>
  <reference>
    <citation>Caruso CC. Negative impacts of shiftwork and long work hours. Rehabil Nurs. 2014 Jan-Feb;39(1):16-25. doi: 10.1002/rnj.107. Epub 2013 Jun 18.</citation>
    <PMID>23780784</PMID>
  </reference>
  <reference>
    <citation>Tahghighi M, Rees CS, Brown JA, Breen LJ, Hegney D. What is the impact of shift work on the psychological functioning and resilience of nurses? An integrative review. J Adv Nurs. 2017 Sep;73(9):2065-2083. doi: 10.1111/jan.13283. Epub 2017 Mar 27.</citation>
    <PMID>28229469</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>December 3, 2021</last_update_submitted>
  <last_update_submitted_qc>December 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammation</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Shift Work</keyword>
  <keyword>Sleep</keyword>
  <keyword>Cognitive Performance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03789188
org study id: 190035
secondary id: 19-CC-0035
nct id: NCT03789188
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
Objective: The U.S. health care system requires critical nursing services around the clock,
      resulting in many nurses working overnight hours and having irregular shifts. One symptom
      commonly associated with the nursing workplace is fatigue, affecting up to 80% of Registered
      Nurses (RNs). Fatigue is problematic for RNs because it is associated with burnout,
      absenteeism, job-related injury and reduced job performance. Factors

      known to contribute to fatigue are physiological (e.g. sleep disturbances, physical health
      and nutritional deficiencies), psychological (e.g. depression, anxiety, coping style), and
      situational (e.g. shiftwork and high work demands). Fatigue in turn negatively affects
      cognitive performance including memory, attention, and reaction time, as well as mood and
      quality of life. The pathophysiological mechanisms underlying fatigue are complex and not
      well understood. Hypothesized pathways include inflammation and autonomic dysregulation. The
      specific physiological, psychological and situational factors contributing to fatigue in RNs
      are unclear. Most studies in nurses look at fatigue in general, with few examining specific
      subtypes such as mental, physical, and emotional fatigue. Very few studies have examined
      fatigue in RNs longitudinally, nor have they explored the underlying pathophysiology. Little
      is known about the downstream effects of fatigue on nurses cognitive performance or on their
      ability to enjoy and participate in life outside of work. Thus, the objective of this study
      is to characterize fatigue experienced by RNs and to examine the physiologic, psychologic,
      and situational factors that contribute to fatigue and its subtypes.

      AIMS: The primary AIM is to characterize the levels and types of fatigue experienced by RNs,
      and to examine the physiologic, psychologic and situational factors contributing to fatigue
      and its subtypes in RNs. The secondary AIM is to examine the relationship between fatigue
      with cognitive performance, mood, life satisfaction, and the ability to participate in social
      roles/activities in RNs and to assess changes in cognitive performance and mood over the
      course of three working days. The exploratory AIM is to explore molecular and clinical
      biomarkers associated with fatigue in a subset of RNs.

      Study population: This study will occur in two parts. Phase I will recruit from a pool of
      approximately 1,275 RNs at the NIH Clinical Center, and we anticipate that 400 RNs will
      participate. Phase II will enroll up to 60 RNs, in order to obtain 40 RNs who complete all
      study timepoints.

      Design: This study will utilize an adaptive design whereby a preliminary, anonymous
      cross-sectional surveyinvolving a large cohort of RNs will address the primary and secondary
      AIMs (Phase I). Phase II will utilize a prospective, repeated measures design to collect
      biomarkers of fatigue and health, along with more detailed psychologic, situational, and
      performance outcomes in a small subset of RNs (n = 40) at multiple time points including
      baseline (48+ hours after last working) and at the start and conclusion of three consecutive
      workdays. Phase II will address the primary and secondary AIMS in greater depth and over
      time, while addressing the exploratory AIMs of the study.

      Outcome measures: The primary outcome is fatigue, using the Multidimensional Fatigue Symptom
      Inventory- Short Form (MFSI-SF) and Occupational Fatigue Exhaustion Recovery (OFER) scale
      used to: (1) determine the levels and types (general, physical, emotional, mental, acute and
      chronic) of fatigue experienced by RNs (Phase I), (2) examine whether fatigue and its
      subtypes change over time (Phase II); and (3) determine which physiologic (sleep disturbance,
      physical health, nutritional status), psychologic (depression, anxiety, self-efficacy, coping
      style), and situational (job type, work hours, work demands, professional quality of life,
      outside demands) factors contribute to fatigue in RNs. Secondary outcomes include downstream
      performance outcomes believed to be related to fatigue including NIH toolbox measures of
      cognitive performance, Profile of Mood States (POMS), and PROMIS measures of life
      satisfaction and the ability to perform social roles/activities. Exploratory factors that
      potentially influence fatigue (MFSI-SF) will be examined in Phase II including markers of
      autonomic function (orthostatic blood pressure (BP) and inflammation (hs-CRP, TNF-alpha,
      IL-6, IL1-beta, and GlycA).
observational model: Cohort
time perspective: Other
measure: 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 shift)
description: 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
measure: (Exploratory outcome) Clinical factors/Biomarkers associated with fatigue
time frame: Phase II: Baseline and Workday three (end of shift)
description: Exploratory biomarkers potentially related to fatigue that will be examined include orthostatic blood pressure (measure of autonomic function) and inflammatory biomarkers (hs-CRP, TNF-?, IL-6, IL1-(SqrRoot) , and GlycA)
measure: "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 ability t...
time frame: 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 shift)
description: These performance measures are questionnaires designed to collect information about downstream outcomes that are known to be associated with fatigue
arm group label: Healthy Volunteers
description: CC Registered Nurses
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alyson C. Ross, R.N.
role: Principal Investigator
affiliation: National Institutes of Health Clinical Center (CC)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2019-CC-0035.html
description: NIH Clinical Center Detailed Web Page
citation: Caruso CC, Baldwin CM, Berger A, Chasens ER, Landis C, Redeker NS, Scott LD, Trinkoff A. Position statement: Reducing fatigue associated with sleep deficiency and work hours in nurses. Nurs Outlook. 2017 Nov-Dec;65(6):766-768. doi: 10.1016/j.outlook.2017.10.011. No abstract available.
PMID: 29216975
citation: Caruso CC. Negative impacts of shiftwork and long work hours. Rehabil Nurs. 2014 Jan-Feb;39(1):16-25. doi: 10.1002/rnj.107. Epub 2013 Jun 18.
PMID: 23780784
citation: Tahghighi M, Rees CS, Brown JA, Breen LJ, Hegney D. What is the impact of shift work on the psychological functioning and resilience of nurses? An integrative review. J Adv Nurs. 2017 Sep;73(9):2065-2083. doi: 10.1111/jan.13283. Epub 2017 Mar 27.
PMID: 28229469
responsible party type: Sponsor
mesh term: Fatigue