FatigueNCT03789188
Characterizing Fatigue Experienced by Registered Nurses
An observational study of Fatigue, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue
- How many people
- 313 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2019to 1 Sep 2021
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: registered nurses working in the National Institutes of Health Clinical Center
Who may be able to join
- 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
Show all 11Show fewer
- Phase II
- CCND credentialed RN employed full time
- Age > 18 years old
- Able to read and speak English
- Agrees to participate in the study
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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).
- Conditions
- Fatigue
- Keywords
- Inflammation, Nutrition, Shift Work, Sleep, Cognitive Performance
- Medical subject headings
- Fatigue, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | CC Registered Nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue - as measured by the Multidimensional Fatigue Symptom Inventory (MFSI) and the Occupational Fatigue Exhaustion Recovery Scale (OFER)
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
Measured: 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)
Secondary outcomes (2)
(Exploratory outcome) Clinical factors/Biomarkers associated with fatigue
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)
Measured: Phase II: Baseline and Workday three (end of shift)
"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...
These performance measures are questionnaires designed to collect information about downstream outcomes that are known to be associated with fatigue
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start29 Apr 2019
- Primary completion22 May 2019
- Study completion1 Sep 2021
Why it stopped: Investigator left NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alyson C. Ross, R.N., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789188
- Sponsor's protocol ID
- 190035
- Other IDs
- 19-CC-0035
- Status last verified
- Sep 2021
- First submitted
- 27 Dec 2018
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29216975Caruso 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.
PubMed 23780784Tahghighi 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.
PubMed 28229469
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Fatigue Experienced by Registered Nurses
- ClinicalTrials.gov ID
- NCT03789188
- Acronym / sponsor ID
- 190035
- Conditions
- Fatigue
- Keywords
- Inflammation, Nutrition, Shift Work, Sleep, Cognitive Performance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left NIH
- Enrolment
- 313 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 28 Dec 2018 (actual)
- 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.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –CC Registered Nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- registered nurses working in the National Institutes of Health Clinical Center
Key inclusion criteria (11 listed)
- Phase I
- CCND credentialed RN
- Age > 18 years old
- Able to read and speak English
- Agrees to participate in the study
Key exclusion criteria (16 listed)
- Phase I
- Age < 18 years old
- Inability to comprehend investigational nature of study
- Unable to read and speak English
- Unable to complete online surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
2 secondary outcomes
(Exploratory outcome) Clinical factors/Biomarkers associated with fatigue
Time frame: Phase II: Baseline and Workday three (end of shift)
"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)
Results and safety
The study was stopped early (reason given: Investigator left NIH). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Background: PubMed 29216975Caruso 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.
- Background: PubMed 23780784Caruso 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.
- Background: PubMed 28229469Tahghighi 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Alyson C. Ross, R.N. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue, run by National Institutes of Health Clinical Center (CC) 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 11 inclusion and 16 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: stopped early, as of the sponsor's last update on 6 Dec 2021. 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?
The study was stopped early (reason given: Investigator left NIH). 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03789188, which also lists 3 linked publications.
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 6 Dec 2021.