CClinicalTrials.gg
WithdrawnNCT06015646Updated Apr 24, 2026

Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents

An interventional study of Personalized lifestyle coaching and educational handout and Handout in Lifestyle, Healthy, Sleepiness and Alertness, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

Why this study was withdrawn
Logistical/staffing challenges in conducting tests overnight
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether personalized lifestyle coaching minimizes the negative impact of circadian disruption on performance and recovery in emergency medicine physician trainees during night shifts.

Read the detailed description

The goal of this study is to examine whether a brief personalized fatigue-mitigation lifestyle coaching (PFMLC) for emergency medicine residents on overnight shifts would minimize the negative effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices.

02

Conditions studied

  • Lifestyle, Healthy
  • Sleepiness
  • Alertness
  • Shift-Work Related Sleep Disturbance
  • Work Related Stress
  • Self Efficacy
  • Self-Compassion

Keywords

  • physician well-being
  • occupational well-being
  • resident well-being
  • physician coaching
  • lifestyle coaching
  • night shifts
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Stanford Health Care (SHC) Emergency Medicine residents (PGY 1 to 4)
  • Scheduled to work at least 3 consecutive overnight shifts at SHC Emergency Department.

Exclusion criteria

Exclusion Criteria:

  • Non-Stanford Health Care (SHC) Emergency Medicine residents
  • Stanford Health Care (SHC) Emergency Medicine residents who are not rotating in Stanford Emergency Medicine Department
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Lifestyle Coaching and Educational Handout

    Lifestyle coach-led 30-minute focused, personalized session in addition to educational handout containing lifestyle tips for fatigue mitigation in night shift workers, which will be given to all participants at the beginning of the study.

    Behavioral: Personalized lifestyle coaching and educational handout · Behavioral: Handout

  • Active comparator
    Educational Handout Control

    An educational handout containing lifestyle tips for fatigue mitigation in night shift workers will be given to all participants at the beginning of the study. Personalized coaching will not be offered to participants in this arm.

    Behavioral: Handout

Interventions

  • BehavioralPersonalized lifestyle coaching and educational handout

    Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study. Participants will also receive a 30-minute focused, personalized lifestyle coaching within a week of the initial overnight shift. The lifestyle coach will be in close contact during the night shifts.

  • BehavioralHandout

    Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study

05

What researchers measure

Primary outcomes

  1. Mean of the 3 overnight reaction time reciprocal of the psychomotor vigilance test

    The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the 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. Investigators will compare the mean of the 3 overnight Mean reaction time reciprocal (lower is desirable) of the PVT tests between the control and intervention groups.

    Time frame: 3 night shifts

  2. Mean of the 3 overnight number of lapses in psychomotor vigilance test

    The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the 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. Investigators will compare the mean of the 3 overnight number of lapses ( lower is desirable) of the PVT test between the control and intervention groups.

    Time frame: 3 night shifts

  3. Mean of the 3 overnight number of false starts in the psychomotor vigilance test

    The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the 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. Investigators will compare the mean of the 3 overnight number of false starts (lower is desirable) in the PVT test between the control and intervention groups.

    Time frame: 3 night shifts

  4. Mean of the 3 overnight Aggregate Scores of the psychomotor vigilance test

    The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the 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. Investigators will compare the mean of the 3 overnight Aggregate Score (0 worst-100 best and derived from the number of lapses and false starts) of the PVT test between the control and intervention groups.

    Time frame: 3 night shifts

  5. Mean of the 3 overnight 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. Investigators will compare the mean of the 3 overnight SSS scores between the control and intervention groups

    Time frame: 3 night shifts

  6. Mean of the 3 overnight 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. Investigators will compare the mean of the 3 overnight Noordsy-Dahle Subjective Experience Scale scores between the control and intervention groups.

    Time frame: 3 night shifts

Secondary outcomes

  1. Mean of total sleep hours

    Investigators will compare total sleep hours per 24-hour period during a baseline week, a night float week, and a recovery week using FitBit Versa 4, between the two groups.

    Time frame: 3 weeks

  2. Mean of heartrate variability

    Investigators will compare the heart rate variability per 24-hour period during a baseline week, a night float week, and a recovery week using Fitbit Versa 4, between the two groups.

    Time frame: 3 weeks

Other outcomes

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

    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. It takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. Investigators will compare the percentage change from baseline between the two groups. The minimum score is 8 and the maximum is 40 and linked to T-scores ranging from 30 to 80.1. With lower scores being more favorable.

    Time frame: 3 weeks

  2. Percentage change from baseline in Task Load Index

    The National Aeronautics and Space Administration (NASA) Task Load Index (TLX) is included as an exploratory outcome measure in this study. The TLX is a measure of perceived workload and is used to measure cognitive load. Lower scores are more desirable. It takes about 1 minute to complete and will be measured at the beginning of the study and at the end of the study. Investigators will compare the percentage change from baseline between the two groups. The score ranges from 0 to 600 with lower scores being more favorable.

    Time frame: 3 weeks

06

Study locations

1 site
  • Stanford Medicine
    Palo Alto, California 94303, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06015646
Lead sponsor
Stanford University
Responsible party
Maryam S Makowski, PhD (Clinical Assistant Professor, Stanford University) — Principal investigator
First posted
Aug 29, 2023
Start date
Mar 31, 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025 (estimated)
Last update
Apr 24, 2026

Study contacts

Al'ai Alvarez, MD
principal investigator · Stanford University
Maryam S Makowski, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion