Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
305 participants
INTERVENTIONAL
2020-04-23
2021-05-07
Brief Summary
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The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.
Detailed Description
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Participants who are assigned to the intervention arm will receive a text message containing a link to an online website that reviews how to safely self-prone position and a recommendation to self-prone position 4 times for 1-2 hours each during the day and at night every 24 hours. Participants will also receive twice daily reminders to self-prone using the same smartphone platform.
All participants will receive twice daily Qualtrics online surveys to answer questions about which body positions they used in bed and their level of comfort and shortness of breath. Participants will receive these twice daily text messages until they are discharged, until they are transferred to the ICU, until they die, until their lung function declines, or until 14 days pass since enrollment. Thus, most participants will receive twice daily text messages for about 1 week; it is expected that almost all patients will receive twice daily text messages for no longer than 14 days. Medical charts will be reviewed daily to track routine clinical data to determine outcomes.
Boston Medical Center (BMC) / Boston University will be one of the 16 sites and the data coordinating center for this multisite trial. The unique design of the study means that if evidence accumulates that one treatment is better than the other, more participants will be chosen to receive the prone position intervention that works over time. Thus, the trial will both show what works, implement what works, and make sure that the most participants receive the treatment that works.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group
Participants in the intervention arm will receive a text message on their smartphones linking to the Qualtrics intervention website
Self-prone position recommendation
The Qualtrics self-prone position recommendation intervention website will include the following sections:
1. Welcome message
2. Educational review of the potential benefits of prone positioning
3. How-To guide to safely "prone" in a hospital bed
4. A recommendation to "prone" while lying in bed (4 times for 1-2 hours each during the day and at night every 24 hours).
5. A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking
Usual care group
Participants in the usual care arm will receive a text message on their smartphone linking to the Qualtrics usual care website
Usual care
The Qualtrics usual care website will include the following sections:
1. Welcome message
2. A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking
Interventions
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Self-prone position recommendation
The Qualtrics self-prone position recommendation intervention website will include the following sections:
1. Welcome message
2. Educational review of the potential benefits of prone positioning
3. How-To guide to safely "prone" in a hospital bed
4. A recommendation to "prone" while lying in bed (4 times for 1-2 hours each during the day and at night every 24 hours).
5. A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking
Usual care
The Qualtrics usual care website will include the following sections:
1. Welcome message
2. A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking
Eligibility Criteria
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Inclusion Criteria
* Have access to their own functioning smartphone in the hospital room
* English or Spanish-speaking
* Ability to read simple instructions and answer simple written questions
Exclusion Criteria
* Inability to operate the hospital bed
* Inability to lie flat comfortably
* Inability to lie flat without shortness of breath
* Inability to turn over independently
Medical comorbidities
* Hemoptysis in the last 2 days
* Prior lung transplant
* Dementia
Acute issues
* Deep venous thrombosis treated for less than 2 days
* Unstable spine, femur, or pelvic fractures
* Mean arterial pressure lower than 65 mmHg
* Receiving ≥6 liters per minute of supplemental oxygen via nasal cannula, nasal pendant, or shovel mask
* Receiving supplemental oxygen via more aggressive methods (e.g. Venturi mask or non-rebreather mask)
Recent interventions
* Chest tube in place
* Tracheal surgery or sternotomy during the previous 15 days
* Serious facial trauma or facial surgery during the previous 15 days
* Cardiac pacemaker inserted in the last 2 days
Other
* Pregnancy
* Comfort measures only status
* Prisoner
18 Years
ALL
No
Sponsors
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Boston University
OTHER
Responsible Party
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Principal Investigators
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Allan J Walkey, MD
Role: STUDY_DIRECTOR
Boston University
Locations
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Long Beach Medical Center - MemorialCare
Long Beach, California, United States
Alvarado Hospital
San Diego, California, United States
St. Joseph's Hospital National Jewish Health
Denver, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Piedmont Atlanta
Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Creighton University
Omaha, Nebraska, United States
Michael E. DeBakey Veteran Affairs Medical Center
Houston, Texas, United States
VCU Medical Center
Richmond, Virginia, United States
Hospital Universitario La Paz
Madrid, , Spain
Countries
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References
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Garcia MA, Rampon GL, Doros G, Jia S, Jagan N, Gillmeyer K, Berical A, Hudspeth J, Ieong M, Modzelewski KL, Schechter-Perkins EM, Ross CS, Rucci JM, Simpson S, Walkey AJ, Bosch NA. Rationale and Design of the Awake Prone Position for Early Hypoxemia in COVID-19 Study Protocol: A Clinical Trial. Ann Am Thorac Soc. 2021 Sep;18(9):1560-1566. doi: 10.1513/AnnalsATS.202009-1124SD.
Rampon G, Jia S, Agrawal R, Arnold N, Martin-Quiromicrons A, Fischer EA, Malatack J, Jagan N, Sergew A, Case AH, Miller K, Tanios M, Doros G, Ross CS, Garcia MA, Gillmeyer KR, Griffiths NG, Jandali B, Modzelewski KL, Rucci JM, Simpson SQ, Walkey AJ, Bosch NA. Smartphone-Guided Self-prone Positioning vs Usual Care in Nonintubated Hospital Ward Patients With COVID-19: A Pragmatic Randomized Clinical Trial. Chest. 2022 Oct;162(4):782-791. doi: 10.1016/j.chest.2022.05.009. Epub 2022 May 18.
Other Identifiers
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H-40070
Identifier Type: -
Identifier Source: org_study_id