- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02946736
Oregon Military Employee Sleep and Health Study (MESH)
Evaluation of a Work-Family and Sleep Leadership Intervention in the Oregon National Guard: A Behavioral Health Leadership Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overall goal of the Military Employee Sleep and Health (MESH) study is to improve safety, health and well-being of service members in the Oregon National Guard and their families. The MESH Study seeks to do this by training supervisors to support Oregon National Guard service members by focusing on a reduction in work-life stress while increasing sleep health.
The Oregon MESH Study proposes that leadership can influence a fundamental change in the recognition of sleep health and service members' overall well-being and the well-being of their family members. With the support of the Oregon National Guard, the MESH Study will provide family-support and sleep leadership training for supervisors while raising awareness of sleep through daily non-invasive sleep measurements.
The investigators of the Oregon MESH Study expect positive results for study participants, including reduced stress and increased social support. Longer term, these effects are expected to create a more supportive work environment, which has positive effects on safety, health, well-being, family, and organizational outcomes. The investigators also expect that providing service members with individual sleep feedback will reduce sleep problems and improve sleep awareness.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Full-time employees in the Oregon National Guard, including Military Technicians and Active Guard Reserves.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Supervisor Intervention
Supervisors in the intervention group will go through the FSSB/sleep leadership training and receive actigraphy feedback.
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Supervisors will receive a training addressing family-supportive supervisor behaviors and sleep leadership.
Supervisors and employees will receive personalized feedback on their sleep and activity measurements.
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Experimental: Employee Intervention
Employees in the intervention group will receive actigraphy feedback.
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Supervisors and employees will receive personalized feedback on their sleep and activity measurements.
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No Intervention: Waitlist Control
Supervisor training and actigraphy feedback provided AFTER final 9 month data collection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Reported Sleep Duration
Time Frame: 4 months
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Total number of hours calculated from reported bed time and wake time.
Minimum 0 hours, Maximum 24 hours.
Longer duration indicates longer sleep duration.
Ideal range is 7-9 hours of sleep per night.
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4 months
|
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Self-Reported Sleep Duration
Time Frame: 9 months
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Total number of hours calculated from reported bed time and wake time.
Minimum 0 hours, Maximum 24 hours.
Longer duration indicates longer sleep duration.
Ideal range is 7-9 hours of sleep per night.
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9 months
|
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Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Disturbance Insomnia Subscale
Time Frame: 4 months
|
Four item subscale of the larger 8 item Sleep Disturbance scale. Likert-type responses: 1 = Not at all to 5 = Very much). T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option. T-Scores estimates were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with. The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more of the concept being measured (worse). |
4 months
|
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Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Disturbance Insomnia Subscale
Time Frame: 9 months
|
Four item subscale of the larger 8 item Sleep Disturbance scale. Likert-type responses: 1 = Not at all to 5 = Very much). T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option. T-Scores estimates were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with. The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more of the concept being measured. |
9 months
|
|
Patient Reported Outcomes Measurement Information System (PROMIS): Dissatisfaction With Sleep Subscale
Time Frame: 4 months
|
Four item subscale of the larger 8 item Sleep Disturbance scale. Likert-type responses: 1 = Not at all to 5 = Very much. T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option. T-Scores estimates were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with. The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more of the concept being measured (worse). |
4 months
|
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Patient Reported Outcomes Measurement Information System (PROMIS): Dissatisfaction With Sleep Subscale
Time Frame: 9 months
|
Four item subscale of the larger 8 item Sleep Disturbance scale. Likert-type responses: 1 = Not at all to 5 = Very much). T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option. T-Scores estimates for Dissatisfaction with Sleep were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with. The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more of the concept being measured (worse). |
9 months
|
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Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Related Impairment Subscale (SRI)
Time Frame: 4 months
|
8 item scale. Likert-type responses: 1 = Not at all to 5 = Very much). T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option. T-Scores estimates for SRI were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with. The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more sleep impairment (worse). |
4 months
|
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Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Related Impairment Subscale (SRI)
Time Frame: 9 months
|
8 item scale. Likert-type responses: 1 = Not at all to 5 = Very much). T-Scores were created using HealthMeasures Scoring service, where data are uploaded into the HealthMeasures scoring service website, which generates T-Scores. This is considered the most accurate option. T-Scores estimates for SRI were developed using a population of 2,252 participants, 259 of which had clinical sleep disorders, and was intended to be representative of the US population. This is the reference population that the T-score means and SDs were calibrated and centered with. The T-Scores that HealthMeasures generates are not precisely at a mean of 50 and standard deviation of 10 because they are based on the unique MESH samples. A higher PROMIS T-score represents more sleep impairment (worse). |
9 months
|
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Actigraphic Sleep Duration: Total Sleep Time (TST)
Time Frame: 9 months
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Actigraphic measurements obtained using Actiwatch2 worn for 3 weeks Average sleep duration in hours Great duration generally better, with target range of 7-9 hours each sleep period.
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9 months
|
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Actigraphic Sleep Efficiency: Wake After Sleep Onset (WASO)
Time Frame: 9-months
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Actigraphic measurements obtained using Actiwatch2 worn for 3 weeks Average number of minutes spent awake during the sleep period.
More minutes indicates worse outcome.
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9-months
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Overall Job Satisfaction Scale
Time Frame: 9-months
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Service member satisfaction with current job; Likert-type scale 1 = Strongly disagree to 5 = Strongly agree, mean created from the 3 items. Scores could range from 0-5 with higher levels indicating greater satisfaction. Source: Cammann et al., 1983 |
9-months
|
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Turnover Intentions
Time Frame: 9-months
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Service member intention to quit current job; Two items with responses on Likert-type scale 1 = Strongly disagree to 5 = Strongly agree. Overall score created with a mean of the two items, with higher levels indicating greater intention to leave one's job. Source: Boroff & Lewin, 1997 |
9-months
|
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Perceived Stress Scale
Time Frame: 9-months
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Service member self-reported stress; Likert-type scale 0 = Never to 4 = Very often, combined to a mean score, with a possible range from 0 to 4. Higher scores indicate greater stress (worse). Source: Cohen & Williamson, 1988 |
9-months
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Walter Reed Functional Impairment: Occupational Subscale (OFI)
Time Frame: 9-months
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Service member difficulty with completing work tasks and quality; 6 items with Likert-type responses: 1 = No difficulty at all to 5 = Extreme difficulty, mean score created from all items, with possible score range from 1 to 5. Higher levels indicating greater impairment (worse). Source: Subscale of Overall Functional Impairment by Herrell et al., 2014 |
9-months
|
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Walter Reed Functional Impairment Scale: Personal Functioning Subscale (PFI)
Time Frame: 9-months
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Service member difficulty with getting personal life skills completed; 2 items with Likert-type responses: 1 = No difficulty at all to 5 = Extreme difficulty, mean score created from all items, with possible score range from 1 to 5. Higher levels indicating greater impairment (worse). Source: Subscale of Overall Functional Impairment by Herrell et al., 2014 |
9-months
|
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Walter Reed Functional Impairment Scale: Social Functional Impairment Subscale (SFI)
Time Frame: 9-months
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Service member difficulty functioning in social situations; 4 items with Likert-type responses: 1 = No difficulty at all to 5 = Extreme difficulty, mean score created from all items, with possible score range from 1 to 5. Higher levels indicating greater impairment (worse). Source: Subscale of Overall Functional Impairment by Herrell et al., 2014 |
9-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Family Supportive Supervisor Behaviors (FSSB)
Time Frame: 4-months
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Perceived supervisor support for work-family integration as reported by service member, 4 items, with responses on Likert-type scale 1=Strongly disagree to 5= Strongly agree, overall score created by mean score, with possible scores ranging from 1 to 5.. Higher scores indicating higher levels of support (better) Source: Hammer et al., 2013 |
4-months
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Sleep Leadership
Time Frame: 4-months
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Perceived supervisor support for sleep health as reported by service member, 8 items, with responses on Likert-type scale 1=Never to 5= Always, overall score created by mean score, with possible scores ranging from 1 to 5.. Higher scores indicating higher levels of support (better) Source: Modified version of Gunia et al., 2015 |
4-months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Leslie Hammer, PhD, Oregon Health and Science University
Publications and helpful links
General Publications
- Hobfoll, S. E., Vinokur, A. D., Pierce, P. F., & Lewandowski-Romps, L. (2012). The combined stress of family life, work, and war in Air Force men and women: A test of conservation of resources theory. International Journal of Stress Management, 19(3), 217-237.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- W81XWH-16-1-0720
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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