- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06015646
Lifestyle Coaching for Fatigue Mitigation in Emergency Medicine Residents
Lifestyle Education and Personalized Coaching for Fatigue Mitigation in Emergency Medicine Residents: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maryam S Makowski, PhD
- Phone Number: 6504975950
- Email: nnaryann@stanford.edu
Study Contact Backup
- Name: Nikitha Menon, BA
- Phone Number: 6504978741
- Email: nkmenon@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94303
- Recruiting
- Stanford Medicine
-
Contact:
- Nikitha K Menon, BA
-
Principal Investigator:
- Maryam S Makowski, PhD
-
Principal Investigator:
- Al'ai Alvarez, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- Non-Stanford Health Care (SHC) Emergency Medicine residents
- Stanford Health Care (SHC) Emergency Medicine residents who are not rotating in Stanford Emergency Medicine Department
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study
|
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.
|
Participants will receive a one-page educational handout on strategies to minimize fatigue at the beginning of the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean of the 3 overnight reaction time reciprocal of the psychomotor vigilance test
Time Frame: 3 night shifts
|
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. |
3 night shifts
|
Mean of the 3 overnight number of lapses in psychomotor vigilance test
Time Frame: 3 night shifts
|
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. |
3 night shifts
|
Mean of the 3 overnight number of false starts in the psychomotor vigilance test
Time Frame: 3 night shifts
|
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. |
3 night shifts
|
Mean of the 3 overnight Aggregate Scores of the psychomotor vigilance test
Time Frame: 3 night shifts
|
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. |
3 night shifts
|
Mean of the 3 overnight Stanford Sleepiness Scale
Time Frame: 3 night shifts
|
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 |
3 night shifts
|
Mean of the 3 overnight Noordsy-Dahle Subjective Experience Scale (NDSE)
Time Frame: 3 night shifts
|
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. |
3 night shifts
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean of total sleep hours
Time Frame: 3 weeks
|
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.
|
3 weeks
|
Mean of heartrate variability
Time Frame: 3 weeks
|
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.
|
3 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage change from baseline in NIH PROMIS Short Form Sleep-Related Impairment
Time Frame: 3 weeks
|
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.
|
3 weeks
|
Percentage change from baseline in Task Load Index
Time Frame: 3 weeks
|
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.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Al'ai Alvarez, MD, Stanford University
- Principal Investigator: Maryam S Makowski, PhD, Stanford University
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
- IRB-67719
- 254764 (Other Identifier: The Stanford Medicine Teaching and Mentoring Academy)
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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