Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts

NCT ID: NCT06100809

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fatigue Shift Work Type Circadian Rhythm Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

No coaching provided. Nutrional handout only

Group Type ACTIVE_COMPARATOR

Nutrition handout

Intervention Type BEHAVIORAL

Nutrition handout

Intervention

Coaching provided. Nutrition handout also provided

Group Type EXPERIMENTAL

Personalized coaching

Intervention Type BEHAVIORAL

Personalized fatigue mitigation coaching.

Nutrition handout

Intervention Type BEHAVIORAL

Nutrition handout

Interventions

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Personalized coaching

Personalized fatigue mitigation coaching.

Intervention Type BEHAVIORAL

Nutrition handout

Nutrition handout

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Steven Bird

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UMassMemorial Health Care

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Facility Contacts

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Steven Bird, MD

Role: primary

508-421-1422

Other Identifiers

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00000500

Identifier Type: -

Identifier Source: org_study_id

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