Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts

NCT06100809 | Not Yet Recruiting

• 1 other identifier: 00000500
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Emergency Medicine (EM) requires 24/7 staff coverage resulting in healthcare workers' circadian rhythm disruptions that impair clinical and cognitive performance, physical recovery, and contribute to burnout. Multiple well-being surveys continue to highlight EM's challenges with sleep impairment due to the nature of the specialty. Despite evidence that lifestyle strategies effectively optimize performance and recovery, EM residents have variable lifestyle choices to prepare for overnight shifts. This prospective randomized controlled trial will examine whether a pre-shift personalized fatigue-mitigation lifestyle coaching (PFMLC) for EM residents on overnight shifts minimizes the effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices. All participants will receive lifestyle strategy materials on fatigue mitigation to improve performance. Residents' self-reported and biometric data will inform PFMLC in the active arm. Performance and recovery from night shifts will be assessed by changes in sleep, heart rate variability, readiness/recovery, alertness, cognitive performance, and mental health using Fitbit and validated measures.

Conditions

Fatigue; Shift Work Type Circadian Rhythm Sleep Disorder

Keywords

Fatigue; Shift Work

Outcome Measures

Primary Outcomes (5)

• Mean of the change in 3 overnight percentage changes (from pre-shift) in mean reaction time

  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

  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

  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

  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:

  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 Outcomes (2)

• Mean of total hours of sleep

  1 week of baseline, during the 1 week of night shifts, and for 1 week after the night shifts

• Mean of heart rate variability

  1 week of baseline, during the week of night shifts, and for 1 week after the night shifts

Other Outcomes (2)

• Percentage change from baseline in NIH PROMIS Short Form Sleep-Related Impairment

  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

  1 week of baseline, during the week of night shifts, and for 1 week after the night shifts

Study Arms (2)

Control

ACTIVE COMPARATOR

No coaching provided. Nutrional handout only

Behavioral: Nutrition handout

Intervention

EXPERIMENTAL

Coaching provided. Nutrition handout also provided

Behavioral: Personalized coaching; Behavioral: Nutrition handout

Interventions

Personalized coaching BEHAVIORAL

Personalized fatigue mitigation coaching.

Intervention

Nutrition handout BEHAVIORAL

Nutrition handout

Control; Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• emergency medicine resident
• scheduled to work at least 4 overnight consecutive shifts

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMassMemorial Health Care

Worcester, Massachusetts, 01655-0002, United States

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: October 25, 2023
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)