Mental FatigueNCT02895997
Turning Night Into Day: Transcontinental Provision of Telehealth By and For the Emory Community
A study testing Travel Telehealth Delivery in people with Mental Fatigue, run by Emory University at 1 site in United States.
Trial summary
The purpose of the study is to determine if temporarily relocating clinicians who deliver remote care using the eICU telehealth system to Sydney, Australia will lead to greater job satisfaction, reduced physiologic stress, and improve performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Fatigue
- What is being tested?
- Travel Telehealth Delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinicians working in the clinical operations room at Emory University Hospital who volunteer participation in the study
Who cannot join
- Declining to participate after the first phase of data collection
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine if temporarily relocating clinicians who deliver remote care using the eICU telehealth system to Sydney, Australia will lead to greater job satisfaction, reduced physiologic stress, and improve performance. Four nurses and six physicians will be sent to a site in Sydney Australia on a rotating basis to determine whether providing care during the Australian daytime is more efficient and precise than providing care during the night in the United States.
Read the detailed description
The purpose of the study is to determine if temporarily relocating clinicians who deliver remote care using the eICU telehealth system to Sydney Australia will lead to greater job satisfaction, reduced physiologic stress, and improve performance. Four nurses and six physicians will be sent to a site in Sydney Australia on a rotating basis to determine whether providing care during the Australian daytime is more efficient and precise than providing care during the night in the United States.
As part of this pilot, each participant will undergo a series of evaluations before leaving, while in Australia, and after returning. The evaluations will include questionnaires related to well-being, task assessment (such as completing a paper maze or performing arithmetic), physiology assessment (such as continuous measure of heart rate by a wristwatch type device), and stress assessment (by sampling saliva and measuring cortisol and interleukin-1 Beta).
The researchers would like to determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves subjective and objective well-being. Additionally, investigators seek to determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves alertness and focus, and determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves job performance.
- Conditions
- Mental Fatigue
- Being tested
- Travel Telehealth Delivery
- Keywords
- mental fatigue, critical care
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travel Telehealth DeliveryOther
Clinical Operations Room (COR) staff will travel to Sydney Australia to deliver telehealth to patients in Georgia United States. Upon arrival, participants will have eight nights and seven days free of clinical responsibilities. Thereafter, each participant will work four consecutive days of 12 hour shifts followed by four consecutive days with no clinical assignment. The following week, participants will work three consecutive days of 12 hour shifts followed by four consecutive days with no clinical assignment. Upon return to the USA, participants will have a week free of clinical responsibilities.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Operations Room Staff | Experimental | Clinicians and critical care nurse volunteers from the clinical operations room (COR) staff at Emory University Hospital will travel to Sydney Australia to deliver telemedicine. Receives: Other: Travel Telehealth Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Cortisol Levels
Saliva will be collected via a mouth swab and tested for cortisol levels. Cortisol is a stress biomarker.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Secondary outcomes (18)
Change in Stanford Sleepiness Scale Score
The Stanford Sleepiness Scale is a seven point scale that asks participants to assess how alert they are feeling throughout the day. A result of 4 or below may indicate that a participant could be suffering from a lack of sleep
Measured: Baseline, Post Intervention (Up to 8 weeks)
Change in the Trail Making Test A Score
During the Trail Making Test A, participants will be asked to draw lines to connect circled numbers in a numerical sequence (i.e., 1-2-3, etc.) as rapidly in possible. A shorter time indicates better cognition.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Change in the Trail Making Test B Score
During the Trail Making Test B, participants will be asked to draw lines to connect circled numbers and letters in an alternating numeric and alphabetic sequence (i.e., 1-A-2-B, etc.) as rapidly as possible. A shorter time indicates better cognition.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Change in Physical Activity assessed by Multi-Scale Entropy
Multi-scale entropy will be measured using a Jawbone wristband device provided to participants upon enrollment.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Change in Physical Activity assessed by Multi-Scale Complexity
Multi-scale complexity will be measured using a Jawbone wristband device provided to participants upon enrollment.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Change in Heart Rate Variability assessed by Deceleration Capacity
Deceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Change in Heart Rate Variability assessed by Acceleration Capacity
Acceleration capacity will be measured using a Jawbone wristband device provided to participants upon enrollment.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Frequency of Arrhythmias
The frequency of arrhythmias will be collected using a Jawbone wristband device provided to participants upon enrollment.
Measured: Duration of Study (Up to 31 Days)
Change in Sleep Latency
Sleep latency is the length of time it takes to accomplish the transition from full wakefulness to sleep. This will be measured in minutes using a Jawbone wristband device provided to participants upon enrollment.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Number of Awakenings per Hour
The number of times a participants awakes during sleep will be monitored at every hour using a Jawbone wristband device provided to participants upon enrollment.
Measured: Duration of Study (Up to 31 Days)
Change in Percent of Non Rapid Eye Movement (REM) Sleep
Change is the difference between the percentage of non REM sleep taken during performance phases.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Change in Mood Symptom Questionnaire Score
The Mood Symptom Questionnaire was originally designed to diagnose bipolar disorder. The questionnaire takes about five minutes to complete, and can provide important insights into diagnosis and treatment.If the patient answers "Yes" to seven or more of the 13 items in question number 1 AND "Yes" to question number 2 AND "Moderate" or "Serious" to question number 3, there is a positive screen.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The PHQ-9 is a multi-purpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. A score of 5-9 represents signs of minimal depression symptoms. A score of 10-14 represents symptoms of minor depression. A score of 15-19 represents symptoms of major depression, moderately severe. A score of greater than 20 represents symptoms of major depression, severe.
Measured: Baseline, Post Intervention (Up to 8 weeks)
Change in Number of Camera Sessions
Difference in the number of camera sessions completed during performance phases.
Measured: Day 1, Day 31
Change in Duration of Camera Sessions
Difference in the duration of camera sessions during performance phases measured in minutes.
Measured: Day 1, Day 31
Change in Urgency of Clinical Contacts
Difference in priority levels assigned to each clinical contact (levels: preventative; informative/procedural; urgent; life-threatening)
Measured: Day 1, Day 31
Change in Number if Clinical Record Entries
Difference in the number of clinical record entries made by physicians only during the performance phases.
Measured: Day 1, Day 31
Change in Duration of Service
Difference in the duration of physician services during each performance phase measured in hours.
Measured: Day 1, Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy G. Buchman, PhD, MD, Emory University
- Investigators
- Timothy Buchman, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895997
- Sponsor's protocol ID
- IRB00088367
- Status last verified
- Nov 2018
- First submitted
- 1 Sep 2016
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with future researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turning Night Into Day: Transcontinental Provision of Telehealth By and For the Emory Community
- ClinicalTrials.gov ID
- NCT02895997
- Acronym / sponsor ID
- IRB00088367
- Conditions
- Mental Fatigue
- Keywords
- mental fatigue, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if temporarily relocating clinicians who deliver remote care using the eICU telehealth system to Sydney, Australia will lead to greater job satisfaction, reduced physiologic stress, and improve performance. Four nurses and six physicians will be sent to a site in Sydney Australia on a rotating basis to determine whether providing care during the Australian daytime is more efficient and precise than providing care during the night in the United States.
Detailed description
The purpose of the study is to determine if temporarily relocating clinicians who deliver remote care using the eICU telehealth system to Sydney Australia will lead to greater job satisfaction, reduced physiologic stress, and improve performance. Four nurses and six physicians will be sent to a site in Sydney Australia on a rotating basis to determine whether providing care during the Australian daytime is more efficient and precise than providing care during the night in the United States.
As part of this pilot, each participant will undergo a series of evaluations before leaving, while in Australia, and after returning. The evaluations will include questionnaires related to well-being, task assessment (such as completing a paper maze or performing arithmetic), physiology assessment (such as continuous measure of heart rate by a wristwatch type device), and stress assessment (by sampling saliva and measuring cortisol and interleukin-1 Beta).
The researchers would like to determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves subjective and objective well-being. Additionally, investigators seek to determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves alertness and focus, and determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves job performance.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Operations Room Staff | Experimental | Other: Travel Telehealth DeliveryClinicians and critical care nurse volunteers from the clinical operations room (COR) staff at Emory University Hospital will travel to Sydney Australia to deliver telemedicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinicians working in the clinical operations room at Emory University Hospital who volunteer participation in the study
Key exclusion criteria (1 listed)
- Declining to participate after the first phase of data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Travel Telehealth DeliveryClinical Operations Room (COR) staff will travel to Sydney Australia to deliver telehealth to patients in Georgia United States. Upon arrival, participants will have eight nights and seven days free of clinical responsibilities. Thereafter, each participant will work four consecutive days of 12 hour shifts followed by four consecutive days with no clinical assignment. The following week, participants will work three consecutive days of 12 hour shifts followed by four consecutive days with no clinical assignment. Upon return to the USA, participants will have a week free of clinical responsibilities. | Other | Clinical Operations Room Staff |
Primary outcome
Change in Salivary Cortisol Levels
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Saliva will be collected via a mouth swab and tested for cortisol levels. Cortisol is a stress biomarker.
18 secondary outcomes
Change in Stanford Sleepiness Scale Score
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Change in the Trail Making Test A Score
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Change in the Trail Making Test B Score
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Change in Physical Activity assessed by Multi-Scale Entropy
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Change in Physical Activity assessed by Multi-Scale Complexity
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Change in Heart Rate Variability assessed by Deceleration Capacity
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Change in Heart Rate Variability assessed by Acceleration Capacity
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Frequency of Arrhythmias
Time frame: Duration of Study (Up to 31 Days)
Change in Sleep Latency
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Number of Awakenings per Hour
Time frame: Duration of Study (Up to 31 Days)
Change in Percent of Non Rapid Eye Movement (REM) Sleep
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Change in Mood Symptom Questionnaire Score
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline, Post Intervention (Up to 8 weeks)
Change in Number of Camera Sessions
Time frame: Day 1, Day 31
Change in Duration of Camera Sessions
Time frame: Day 1, Day 31
Change in Urgency of Clinical Contacts
Time frame: Day 1, Day 31
Change in Number if Clinical Record Entries
Time frame: Day 1, Day 31
Change in Duration of Service
Time frame: Day 1, Day 31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: Yes. Data will be shared with future researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Buchman, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Travel Telehealth Delivery in people with Mental Fatigue, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Cortisol Levels (time frame: Baseline, Post Intervention (Up to 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.