- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06100809
Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts
Personalized Fatigue-Mitigation Lifestyle Coaching (PFMLC) to Improve Performance and Recovery Among Emergency Medicine Residents on Night Shifts
Study Overview
Status
Intervention / Treatment
Detailed Description
The investigators will use a block-randomized design utilizing each 28-day scheduling period as a block.
Baseline characteristics and confounding factors such as gender, habitual diet, sleep, and caffeine intake will be collected on the first night of the study. Outcome measures will be assessed at the beginning of the shift and between the hours of 2:00 AM to 5:00 AM when sleep propensity and decreased alertness peak.
Outcome measures include a) Stanford Sleepiness Scale (SSS): which takes about 15 seconds to complete. b) Work Exhaustion (4 questions overall): take 20 seconds to complete. c) electronic psychomotor vigilance test: take 3 minutes to complete. The psychomotor vigilance test is a gamified method to measure both vigilance and reaction time. Done on a phone, a colored block appears on the screen, and when a participant sees the block, the participant taps the screen. Reaction time is measured in milliseconds and the average reaction time over the 3 minutes is calculated by the program and reported to the participant as well as stored in the participant's profile.
Study participants will be required to participate in the study for a total of 18 days. Each study participant will contribute biometric data for 7 days before a string of at least 4 consecutive night shifts, then for another 7 days (for a total of 18 days). A self-care handout containing nutrition tips for fatigue mitigation in night shift workers will be given to all participants at the beginning of the study. A Fitbit device will be provided to all participants to measure biometrics data.
Control: The investigators will not provide personalized coaching and ask the control participants to follow and record their typical nightshift habits. The control participants will participate in the surveys and tests as above. Control participants will receive a daily text message to remind them to do the surveys and tests during their shifts. The investigators will instruct the control participants to make sure their phones are silenced during this time as part of better habits for sleep.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Worcester, Massachusetts, United States, 01655-0002
- UMassMemorial Health Care
-
Contact:
- Steven Bird, MD
- Phone Number: 508-421-1422
- Email: steven.bird@umassmemorial.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- emergency medicine resident
- scheduled to work at least 4 overnight consecutive shifts
Exclusion Criteria:
- not willing to wear Fitbit device during the study
- not willing to answer questionnaires
- not willing to receive text messages during the study
- not willing to meet with a lifestyle coach during the study
- not willing t0 download app to their personal smartphone or residency-supplied smartphone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
No coaching provided.
Nutrional handout only
|
Nutrition handout
|
Experimental: Intervention
Coaching provided.
Nutrition handout also provided
|
Nutrition handout
Personalized fatigue mitigation coaching.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean of the change in 3 overnight percentage changes (from pre-shift) in mean reaction time
Time Frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of mean reaction time reciprocal (lower is desirable). |
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
Mean of the change in 3 overnight percentage changes (from pre-shift) in number of lapses in PVT
Time Frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of number of lapses (lower is desirable). |
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
Mean of the change in 3 overnight percentage changes (from pre-shift) in aggregrate PVT score
Time Frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of aggregate score (0 worst - 100 best). |
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
Mean of the change in 3 overnight percentage changes (from pre-shift) in Stanford Sleepiness Scale
Time Frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
The Sleepiness Symptom Scale (SSS) is a validated subjective measure of sleepiness frequently used for research and clinical purposes. It evaluates sleepiness at specific moments in time using a single-item scale. Respondents select one of seven statements to indicate their level of perceived sleepiness. Score Range: The scale score ranges from 1 to 7, reflecting the varying degrees of sleepiness experienced by respondents. This test takes approximately 15 seconds to complete. Directionality: Higher scores on the SSS represent higher perceived sleepiness, while lower scores indicate increased alertness and desirable. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups. |
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
Mean of the change 3 overnight percentage changes (from pre-shift) in Noordsy-Dahle Subjective Experience Scale (NDSE) Modified version of Noordsy-Dahle Subjective Experience Scale (NDSE) for healthy adults includes 8 sub-domains:
Time Frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
Global well-being: Delighted 1 to Terrible 7, Lower score better Anxiety: None 1 to Extreme 7, Lower score better Depression: None 1 to Extreme 7, Lower score better Energy: Tired 1 to Energized 7, Higher score better Motivation: None 1 to Strong 7, Higher score better Clarity of thought: Clouded 1 to Totally Clear 7, Higher score better Concentration: Poor 1 to Excellent 7, Higher score better Social interest: Alone 1 to With Others 7, Higher score better This test takes approximately 90 seconds to complete.We will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups
|
Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean of total hours of sleep
Time Frame: 1 week of baseline, during the 1 week of night shifts, and for 1 week after the night shifts
|
Total sleep hours per 24-hour period during a baseline week, the period of night shifts, and a recovery week using FitBit Versa 4, between the two groups will be compared.
|
1 week of baseline, during the 1 week of night shifts, and for 1 week after the night shifts
|
Mean of heart rate variability
Time Frame: 1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
|
Heart rate variability per 24-hour period during a baseline week, the period of night shifts, and a recovery week using Fitbit Versa 4, between the two groups will be compared.
|
1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage change from baseline in NIH PROMIS Short Form Sleep-Related Impairment
Time Frame: 1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
|
The NIH PROMIS Short Form Sleep-Related Impairment Scale is included as an exploratory outcome measure in this study.
The Sleep-Related Impairment is designed to assess the impact of sleep-related impairment on various aspects of daily functioning and overall quality of life.
Higher scores indicate greater sleep-related impairment.
The NIH PROMIS takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study.
The investigators will compare the percentage change from baseline between the two groups.
|
1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
|
Percentage change from baseline in Task Load Index
Time Frame: 1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
|
The National Aeronautics and Space Administration\ (NASA) Task Load Index (TLX) is included as an exploratory outcome measure in this study.
The TLX is used to measure cognitive load.
Lower scores are more desirable.
The TLX takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study.
The investigators will compare the percentage change from baseline between the two groups.
|
1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00000500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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