Effects of Mobile App in House Staff Health and Well-being During COVID-19 Pandemic

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Mobile App on Health and Well-being During COVID-19 Pandemic in House Staff at Banner University Medical Center Phoenix

Conditions
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Perceived Stress, Anxiety, Sleep Disturbance, Burnout, PTSD

Intervention / Treatment
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* Device: Calm Meditation App


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Will receive a 30-day are trial of the mobile meditation app Calm on study day 0 | Device: Calm Meditation App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Completed study Day 0 | 
| 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. | Completed study Day 14 | 
| 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. | Completed study Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Completed study Day 0, 14, and study Day 30 | 
| 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. | Completed study Day 0, 14, and study Day 30 | 
| 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. | Completed study Day 0, 14, and study Day 30 | 
| 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. | Completed study Day 0, 14, and study Day 30 | 
| Adherence | Usage data from mobile app, minutes per day used | From Day 0 to Day 30 | 
| 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. | Completed study Day 0 and study Day 30 | 
| Participant Satisfaction | Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length. | Completed study Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, mindfulness meditation