NCT04646642

Brief Summary

The proposed research study aims to better understand COVID deployer needs. The study, informally referred to as Project COPE, asks David Grant U.S. Air Force Medical Center (DGMC) members who deployed in support of COVID-19 operations to complete a needs assessment questionnaire. The purpose of this study is to understand the stressful experiences of our COVID Theater Hospital (CTH) deployers, the typical coping strategies used and recommended preferences for support so that the investigators can provide the best evidence-based resources for post-deployment and to aid future CTH deployers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

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

November 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

April 2, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

November 25, 2020

Last Update Submit

April 1, 2021

Conditions

Outcome Measures

Primary Outcomes (14)

  • Positive Patient Health Questionnaire-2 (PHQ-2)

    Describe the frequencies of positive screen for depression based on total score \>/= 3 on PHQ-2. The PHQ-2 is a 2-item screening tool for depression that uses first 2 items from PHQ-9. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. Total scores exceeding 2 suggest a positive depression screening. This tool provides a brief, practical, valid, and reliable screening instrument.

    1-2 months

  • Positive PHQ-2 + High risk COVID physical condition

    Describe the frequencies and percentages of positive screened PHQ-2 individuals who also responded YES for self-reported high-risk COVID physical conditions on demographic questionnaire. The PHQ-2 is a 2-item screening tool for depression that uses first 2 items from PHQ-9. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. Total scores exceeding 2 suggest a positive depression screening. This tool provides a brief, practical, valid, and reliable screening instrument. The demographic questionnaire consist of 10 questions, one is COVID-19 risk status. A YES response to "Do you have any underlying physical health conditions that place you in a high-risk COVID category would be included in this measure.

    1-2 months

  • Positive PHQ-2 + pre-existing mental health conditions

    Describe the frequencies and percentages of positive screened PHQ-2 individuals who also responded YES for self-reported pre-existing mental health conditions on demographic questionnaire. The PHQ-2 is a 2-item screening tool for depression that uses first 2 items from PHQ-9. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. Total scores exceeding 2 suggest a positive depression screening. This tool provides a brief, practical, valid, and reliable screening instrument. The demographic questionnaire consist of 10 questions, one is mental health risk status. A YES response to "Do you have any underlying mental health concerns (anxiety, depression, difficulty sleeping, etc.), or have you visited a mental health professional in the past 6 months?" would be included in this measure.

    1-2 months

  • Positive Generalized Anxiety Disorder-2 (GAD-2)

    Describe the frequencies of positive screen for depression based on total score \>/= 3 on GAD-2. The GAD-2 is a 2-item screening tool for Generalized Anxiety Disorder. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. A total score of 3 points or greater identifies a positive screen and warrants further diagnostic evaluation with GAD-7 for Generalized Anxiety Disorder criteria. This tool provides a brief, practical, valid, and reliable screening instrument.

    1-2 months

  • Positive GAD-2 + High risk COVID physical condition

    Describe the frequencies and percentages of positive screened GAD-2 individuals who also responded YES for self-reported high-risk COVID physical conditions on demographic questionnaire. The GAD-2 is a 2-item screening tool for Generalized Anxiety Disorder. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. A total score of 3 points or greater identifies a positive screen and warrants further diagnostic evaluation with GAD-7 for Generalized Anxiety Disorder criteria. This tool provides a brief, practical, valid, and reliable screening instrument. The demographic questionnaire consist of 10 questions, one is COVID-19 risk status. A YES response to "Do you have any underlying physical health conditions that place you in a high-risk COVID category would be included in this measure.

    1-2 months

  • Positive GAD-2 + pre-existing mental health conditions

    Describe the frequencies and percentages of positive screened GAD-2 individuals who also responded YES for self-reported pre-existing mental health conditions on demographic questionnaire. The GAD-2 is a 2-item screening tool for Generalized Anxiety Disorder. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. A total score of 3 points or greater identifies a positive screen and warrants further diagnostic evaluation with GAD-7 for Generalized Anxiety Disorder criteria. This tool provides a brief, practical, valid, and reliable screening instrument. The demographic questionnaire consist of 10 questions, one is mental health risk status. A YES response to "Do you have any underlying mental health concerns (anxiety, depression, difficulty sleeping, etc.), or have you visited a mental health professional in the past 6 months?" would be included in this measure.

    1-2 months

  • Positive Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI-A)

    Describe the frequencies of positive screen for depression based on total score \> 4 on PSQI-A. The PSQI-A is a 7-item questionnaire used to examine disruptive nocturnal behaviors common in adults with PTSD. Response items are endorsed for frequency. Scale 0 (not during the past month) to 4 (3 or more times a week), 0 is better and 4 worse. The PSQI-A is a valid instrument for PTSD applicable to both clinical and research settings.

    1-2 months

  • Positive PSQI-A + High risk COVID physical condition

    Describe the frequencies and percentages of positive screened PSQI-A individuals who also responded YES for self-reported high-risk COVID physical conditions on demographic questionnaire. The PSQI-A is a 7-item questionnaire used to examine disruptive nocturnal behaviors common in adults with PTSD. Response items are endorsed for frequency. Scale 0 (not during the past month) to 4 (3 or more times a week), 0 is better and 4 worse. The PSQI-A is a valid instrument for PTSD applicable to both clinical and research settings. The demographic questionnaire consist of 10 questions, one is COVID-19 risk status. A YES response to "Do you have any underlying physical health conditions that place you in a high-risk COVID category would be included in this measure.

    1-2 months

  • Positive PSQI-A + pre-existing mental health conditions

    Describe the frequencies and percentages of positive screened PSQI-A individuals who also responded YES for self-reported pre-existing mental health conditions on demographic questionnaire. The PSQI-A is a 7-item questionnaire used to examine disruptive nocturnal behaviors common in adults with PTSD by frequency. Scale 0 (not during the past month) to 4 (3 or more times a week), 0 is better and 4 worse. The demographic questionnaire consist of 10 questions, one is mental health risk status. A YES response to "Do you have any underlying mental health concerns (anxiety, depression, difficulty sleeping, etc.), or have you visited a mental health professional in the past 6 months?" would be included in this measure.

    1-2 months

  • Deployer Identified COVID-19 Stressors

    Describe the severity of deployer identified COVID-19 stressors. A tool that requests deployers to list top 3 stressors experienced during deployment. Participants rated listed items as: 1-no distress, 2-mildly distressing, 3-distressing, 4- very distressing, and 5-extremely distressing. Scale 0 (no distress) to 5 (extremely distressing), 0 is better and 5 worse.

    1-2 months

  • Positive Brief Coping Orientation to Problems Experienced (Brief COPE)

    Describe the prevalence of positive coping strategies by percentage based on scores \>/= 3 (3-I've been doing this medium amount; 4-I've been doing this a lot) for items targeting: humor, positive reframing, acceptance, active coping, planning, emotional support, instrumental support, religion. The Brief COPE is a 28-item multidimensional measure of 14 strategies (those above, as well as, behavioral disengagement, self-distraction, substance use, denial, self-blame, venting) used for coping or regulating cognitions in response to stressors. This abbreviated inventory (based on the complete 60-item COPE Inventory) is comprised of items that assess the frequency with which a person uses different coping strategies rated on a scale from 0-"I haven't been doing this at all" to 4-"I've been doing this a lot." (Amoyal et al., 2011). 4 is better and 0 worse. Two items related to drugs and alcohol were eliminated to maintain the eligibility of exempt protocol status

    1-2 months

  • Negative Brief Coping Orientation to Problems Experienced (Brief COPE)

    Describe the prevalence of negative coping strategies by percentage based on scores \>/= 3 (3-I've been doing this medium amount; 4-I've been doing this a lot) for items targeting: behavioral disengagement, self-distraction, substance use, denial, self-blame, venting. The Brief COPE is a 28-item multidimensional measure of 14 strategies (those above, as well as, humor, positive reframing, acceptance, active coping, planning, emotional support, instrumental support, religion) used for coping or regulating cognitions in response to stressors. This abbreviated inventory (based on the complete 60-item COPE Inventory) is comprised of items that assess the frequency with which a person uses different coping strategies rated on a scale from 0-"I haven't been doing this at all" to 4-"I've been doing this a lot." (Amoyal et al., 2011). 0 is better and 4 worse. Two items related to drugs and alcohol were eliminated to maintain the eligibility of exempt protocol status

    1-2 months

  • COVID-19 Coping Strategy and Resource Inventory

    Describe the frequency of preferred coping resources using the COVID-19 Coping Strategy and Resource Inventory. This is an 18-item resource inventory developed by our DGMC research team to assess preferred strategic resources to manage COVID-19-related stressors. The inventory includes 5 categories of coping resources: 1) interactive \[exercise, spiritual, social, mental health visit\], 2) self-help videos/webinars, 3) mobile applications, 4) electronic toolkits, 5) podcasts

    1-2 months

  • Demographic questionnaire

    Describe the demographic characteristics of the respondents using the demographic questionnaire. These are 10 questions regarding individual deployer sex, COVID-19 risk status, mental health risk status, COVID-19 risk status of any family members at home, years of experience in current occupation and specific healthcare role, typical work setting at DGMC, any recent deployments.

    1-2 months

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Active duty healthcare workers assigned to David Grant U.S. Air Force Medical Center (DGMC) who deployed in July 2020, under the command of Col Justin Nast and the COVID Theater Hospital (CTH), in support of 8 civilian California hospitals.

You may qualify if:

  • The eligible participant group includes David Grant United States Air Force (USAF) Medical Center Active Duty personnel:
  • Medical technicians (4N)
  • Liaison officers (LNO's)
  • Nurses
  • Physician assistants
  • Advanced practice nurses
  • Respiratory therapists
  • Psychologists
  • Social workers
  • Chaplains
  • Physicians
  • Deployed in July 2020, under the command of Col Justin Nast and the COVID Theater Hospital (CTH) in support of the following civilian facilities:
  • Adventist Health Lodi Memorial Hospital, Lodi, CA
  • Eisenhower Medical Center, Rancho Mirage, CA
  • Community Regional Medical Center, Fresno, CA
  • +5 more criteria

You may not qualify if:

  • Activated guard, reserve, or civilian healthcare deployers in support of COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Grant Medical Center (DGMC)

Travis Air Force Base, California, 94535, United States

Location

Related Publications (29)

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MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Amanda A Fox, MSN

    David Grant Medical Center, Travis Air Force Base

    PRINCIPAL INVESTIGATOR
  • Laurie A Migliore, PhD

    David Grant Medical Center, Travis Air Force Base

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Inquiry in Nursing Readiness Fellow

Study Record Dates

First Submitted

November 25, 2020

First Posted

November 30, 2020

Study Start

December 14, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

April 2, 2021

Record last verified: 2021-04

Locations