NCT02946736

Brief Summary

This study is a randomized controlled trial that assesses the effects of (1) the Family-Supportive Supervisor Behavior (FSSB) and Sleep Leadership training and (2) sleep/cognitive effectiveness feedback intervention on health and well-being among full-time employees in the Oregon National Guard, their supervisors, and their families. The interventions involving both health protection and health promotion are expected to contribute to improvements in employees' and their supervisors' sleep, risk behaviors, mental and physical health, and injury, as well as employees' and their spouse/partners' family experiences, health and well-being, and workplace outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
704

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

July 21, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2020

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

November 1, 2024

Enrollment Period

2.8 years

First QC Date

October 19, 2016

Results QC Date

July 31, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

SleepPhysical HealthPsychological HealthWell-BeingEmployeeActigraphy

Outcome Measures

Primary Outcomes (16)

  • Self-Reported Sleep Duration

    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.

    4 months

  • Self-Reported Sleep Duration

    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.

    9 months

  • Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Disturbance Insomnia Subscale

    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

  • Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Disturbance Insomnia Subscale

    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

    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

  • Patient Reported Outcomes Measurement Information System (PROMIS): Dissatisfaction With Sleep Subscale

    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

  • Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Related Impairment Subscale (SRI)

    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

  • Patient Reported Outcomes Measurement Information System (PROMIS): Sleep Related Impairment Subscale (SRI)

    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

  • Actigraphic Sleep Duration: Total Sleep Time (TST)

    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.

    9 months

  • Actigraphic Sleep Efficiency: Wake After Sleep Onset (WASO)

    Actigraphic measurements obtained using Actiwatch2 worn for 3 weeks Average number of minutes spent awake during the sleep period. More minutes indicates worse outcome.

    9-months

  • Overall Job Satisfaction Scale

    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

  • Turnover Intentions

    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

  • Perceived Stress Scale

    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

  • Walter Reed Functional Impairment: Occupational Subscale (OFI)

    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

  • Walter Reed Functional Impairment Scale: Personal Functioning Subscale (PFI)

    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

  • Walter Reed Functional Impairment Scale: Social Functional Impairment Subscale (SFI)

    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

Secondary Outcomes (2)

  • Family Supportive Supervisor Behaviors (FSSB)

    4-months

  • Sleep Leadership

    4-months

Study Arms (3)

Supervisor Intervention

EXPERIMENTAL

Supervisors in the intervention group will go through the FSSB/sleep leadership training and receive actigraphy feedback.

Behavioral: FSSB/Sleep Leadership TrainingBehavioral: Actigraphy Feedback

Employee Intervention

EXPERIMENTAL

Employees in the intervention group will receive actigraphy feedback.

Behavioral: Actigraphy Feedback

Waitlist Control

NO INTERVENTION

Supervisor training and actigraphy feedback provided AFTER final 9 month data collection.

Interventions

Supervisors will receive a training addressing family-supportive supervisor behaviors and sleep leadership.

Supervisor Intervention

Supervisors and employees will receive personalized feedback on their sleep and activity measurements.

Employee InterventionSupervisor Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full-time employees in the Oregon National Guard, including Military Technicians and Active Guard Reserves.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Health BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Results Point of Contact

Title
Dr. Leslie Hammer, PI
Organization
Oregon Health & Science University

Study Officials

  • Leslie Hammer, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 27, 2016

Study Start

July 21, 2017

Primary Completion

May 22, 2020

Study Completion

December 4, 2020

Last Updated

January 3, 2025

Results First Posted

January 3, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations