Effects of Mobile App in House Staff Health and Well-being During COVID-19 Pandemic
Primary Purpose
Perceived Stress, Anxiety, Sleep Disturbance
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calm Meditation App
Sponsored by
About this trial
This is an interventional supportive care trial for Perceived Stress focused on measuring COVID-19, mindfulness meditation
Eligibility Criteria
Inclusion Criteria:
- All resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.
Exclusion Criteria:
- Non-resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.
Sites / Locations
- Banner University Medical Center Phoenix
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group
Arm Description
Will receive a 30-day are trial of the mobile meditation app "Calm" on study day 0
Outcomes
Primary Outcome Measures
Perceived Stress Scale
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Perceived Stress Scale
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Perceived Stress Scale
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Secondary Outcome Measures
Hospital Anxiety and Depression Scale
Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder.
PROMIS Sleep Disturbance Short Form Survey
Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance.
Impact of Event Scale-6
The Impact of Event Scale-6 is a validated post traumatic event survey, 6 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The score ranges from a minimum of 6 to a maximum of 30 with higher scores indicating higher traumatic stress.
Maslach Burnout Inventory
The Maslach Burnout Inventory is a validated burnout survey, 22 questions in length with 3 sub scales including emotional exhaustion, depersonalization, and personal accomplishment. Each question is rated on a 7 point Likert scale ranging from 0 (never) to 6 (every day). The score for each sub scales range from minimum 0 to maximum 18. High scores of emotional exhaustion and depersonalization sub scales and a lower score of personal accomplishment indicates a higher level of burnout.
Adherence
Usage data from mobile app, minutes per day used
Coronavirus Questionnaire
Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale. 1= very low, 2=low, 3=moderate, 4=high, 5= very high.
Participant Satisfaction
Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04374786
Brief Title
Effects of Mobile App in House Staff Health and Well-being During COVID-19 Pandemic
Official Title
Effects of a Mobile App on Health and Well-being During COVID-19 Pandemic in House Staff at Banner University Medical Center Phoenix
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.
Detailed Description
The COVID-19 global pandemic is significantly impacting healthcare providers and presumably affecting their stress level as they deal with this time of uncertainty. The COVID-19 public health crisis requires the full resources and attention of healthcare systems. This has led to several healthcare changes that affect physicians in training, including changes to rotations and schedules, risks of infection exposure to themselves or their families, and the unknown impacts this may have on their residency and fellowship experiences.
These changes are likely impacting their stress, health, and well-being. Physician burnout is major concern for the medical community and likely to be further impacted by the current pandemic. Evidence-based interventions for stress include cognitive behavior therapy, although this can be time consuming, requires the need for specialized providers, and is not feasible for everyone during this COVID-19 pandemic. Pharmacotherapy can be used, including antidepressants and anxiolytics, however they have inherent limitations such as side effects, tolerance, and interactions that limit their use. Consumer based mobile applications (apps) may help individuals with self-management strategies for stress. Mindfulness meditation is one type of self-management strategy and is the practice of moment-to-moment awareness in which the person purposefully focuses on the present without judgement.
"Calm" is a mobile app that offers a range of meditation lessons, sleep stories (bed-time stories for grown-ups), sleep music, and nature sounds with modules that vary in length, instruction, and content. Few studies on the use of "Calm" exist and include a randomized controlled trial evaluating its affect to decrease stress among college students and a descriptive study evaluating cancer patient's perceptions of the app. There is evidence to support the use of similar apps in resident physicians. A pilot study assessing the effects of a meditation app on resident wellness suggested both the feasibility and efficacy of such an intervention. During these unprecedented times of the COVID-19 pandemic, mobile apps such as Calm may be potentially beneficial to help with stress in house staff physicians, although this requires further investigation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perceived Stress, Anxiety, Sleep Disturbance, Burnout, PTSD
Keywords
COVID-19, mindfulness meditation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Will receive a 30-day are trial of the mobile meditation app "Calm" on study day 0
Intervention Type
Device
Intervention Name(s)
Calm Meditation App
Intervention Description
Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time.
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
Completed study Day 0
Title
Perceived Stress Scale
Description
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
Completed study Day 14
Title
Perceived Stress Scale
Description
Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
Completed study Day 30
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder.
Time Frame
Completed study Day 0, 14, and study Day 30
Title
PROMIS Sleep Disturbance Short Form Survey
Description
Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance.
Time Frame
Completed study Day 0, 14, and study Day 30
Title
Impact of Event Scale-6
Description
The Impact of Event Scale-6 is a validated post traumatic event survey, 6 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The score ranges from a minimum of 6 to a maximum of 30 with higher scores indicating higher traumatic stress.
Time Frame
Completed study Day 0, 14, and study Day 30
Title
Maslach Burnout Inventory
Description
The Maslach Burnout Inventory is a validated burnout survey, 22 questions in length with 3 sub scales including emotional exhaustion, depersonalization, and personal accomplishment. Each question is rated on a 7 point Likert scale ranging from 0 (never) to 6 (every day). The score for each sub scales range from minimum 0 to maximum 18. High scores of emotional exhaustion and depersonalization sub scales and a lower score of personal accomplishment indicates a higher level of burnout.
Time Frame
Completed study Day 0, 14, and study Day 30
Title
Adherence
Description
Usage data from mobile app, minutes per day used
Time Frame
From Day 0 to Day 30
Title
Coronavirus Questionnaire
Description
Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale. 1= very low, 2=low, 3=moderate, 4=high, 5= very high.
Time Frame
Completed study Day 0 and study Day 30
Title
Participant Satisfaction
Description
Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length.
Time Frame
Completed study Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.
Exclusion Criteria:
Non-resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Foley, MD
Organizational Affiliation
Chair - BUMCP
Official's Role
Study Chair
Facility Information:
Facility Name
Banner University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31237569
Citation
Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
Results Reference
result
PubMed Identifier
31682582
Citation
Huberty J, Vranceanu AM, Carney C, Breus M, Gordon M, Puzia ME. Characteristics and Usage Patterns Among 12,151 Paid Subscribers of the Calm Meditation App: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2019 Nov 3;7(11):e15648. doi: 10.2196/15648.
Results Reference
result
PubMed Identifier
32039812
Citation
Huberty J, Puzia M, Eckert R, Larkey L. Cancer Patients' and Survivors' Perceptions of the Calm App: Cross-Sectional Descriptive Study. JMIR Cancer. 2020 Jan 25;6(1):e16926. doi: 10.2196/16926.
Results Reference
result
PubMed Identifier
28795335
Citation
Wen L, Sweeney TE, Welton L, Trockel M, Katznelson L. Encouraging Mindfulness in Medical House Staff via Smartphone App: A Pilot Study. Acad Psychiatry. 2017 Oct;41(5):646-650. doi: 10.1007/s40596-017-0768-3. Epub 2017 Aug 9.
Results Reference
result
Learn more about this trial
Effects of Mobile App in House Staff Health and Well-being During COVID-19 Pandemic
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