Back to resultsThe COVID-19 ICU PRAYER Study
Primary Purpose
Coronavirus Infection
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prayer
Sponsored by
About this trial
This is an interventional supportive care trial for Coronavirus Infection
Eligibility Criteria
Inclusion Criteria:
- Male or female greater than 18 years of age
- Confirmed positive for COVID-19
- Patient admitted to Intensive Care Unit
Exclusion Criteria:
- Patients admitted to ICU for diagnosis that is not COVID-19 positive.
Sites / Locations
- Research Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Prayer
No Prayer
Arm Description
Patients will receive a daily prayer and standard of care treatment from multi-denominational group while in the ICU.
Patients will receive standard of care treatment while in the ICU.
Outcomes
Primary Outcome Measures
Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality.
This study will measure the difference in mortality of COVID-19 patients who are admitted to ICU - given prayer vs no prayer as an adjunct to standard therapy.
Secondary Outcome Measures
Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score.
APACHE II uses 0-71 scale, the higher the score the higher the risk for mortality.
Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score
The higher the SOFA score the increased likelihood of organ failure.
Difference in patient outcomes - Length of stay in ICU.
A prolonged length of time in ICU increases mortality.
Difference in patient outcomes - Length of ventilator support
A prolonged length of time with ventilator support increases mortality.
Difference in patient outcomes - length of vasopressor support
A prolonged length of time with vasopressor support increases recovery time.
Full Information
NCT ID
NCT04361838
First Posted
April 16, 2020
Last Updated
February 1, 2022
Sponsor
Kansas City Heart Rhythm Institute
1. Study Identification
Unique Protocol Identification Number
NCT04361838
Brief Title
The COVID-19 ICU PRAYER Study
Official Title
Impact of Multi-Denominational Prayer on Morbidity and Mortality of Patients Admitted to the Intensive Care Unite With Corona Virus Infection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to the low enrollment, this study is closed. Analysis of data is not performed.
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kansas City Heart Rhythm Institute
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
This is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a "universal" prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prayer
Arm Type
Active Comparator
Arm Description
Patients will receive a daily prayer and standard of care treatment from multi-denominational group while in the ICU.
Arm Title
No Prayer
Arm Type
No Intervention
Arm Description
Patients will receive standard of care treatment while in the ICU.
Intervention Type
Behavioral
Intervention Name(s)
prayer
Intervention Description
receive prayers daily while in ICU
Primary Outcome Measure Information:
Title
Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality.
Description
This study will measure the difference in mortality of COVID-19 patients who are admitted to ICU - given prayer vs no prayer as an adjunct to standard therapy.
Time Frame
daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Secondary Outcome Measure Information:
Title
Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score.
Description
APACHE II uses 0-71 scale, the higher the score the higher the risk for mortality.
Time Frame
daily until patient recovers and moves out of ICU or exits the study, up to 30 days.
Title
Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score
Description
The higher the SOFA score the increased likelihood of organ failure.
Time Frame
daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Title
Difference in patient outcomes - Length of stay in ICU.
Description
A prolonged length of time in ICU increases mortality.
Time Frame
daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Title
Difference in patient outcomes - Length of ventilator support
Description
A prolonged length of time with ventilator support increases mortality.
Time Frame
daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Title
Difference in patient outcomes - length of vasopressor support
Description
A prolonged length of time with vasopressor support increases recovery time.
Time Frame
daily until patient recovers and moves out of ICU or exits the study, up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female greater than 18 years of age
Confirmed positive for COVID-19
Patient admitted to Intensive Care Unit
Exclusion Criteria:
Patients admitted to ICU for diagnosis that is not COVID-19 positive.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD
Organizational Affiliation
Kansas City Heart Rhythm Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
1443246
Citation
Koenig HG, Cohen HJ, Blazer DG, Pieper C, Meador KG, Shelp F, Goli V, DiPasquale B. Religious coping and depression among elderly, hospitalized medically ill men. Am J Psychiatry. 1992 Dec;149(12):1693-700. doi: 10.1176/ajp.149.12.1693.
Results Reference
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PubMed Identifier
9724889
Citation
Koenig HG, George LK, Hays JC, Larson DB, Cohen HJ, Blazer DG. The relationship between religious activities and blood pressure in older adults. Int J Psychiatry Med. 1998;28(2):189-213. doi: 10.2190/75JM-J234-5JKN-4DQD.
Results Reference
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PubMed Identifier
30772739
Citation
Currier JM, Foster JD, Witvliet CV, Abernethy AD, Root Luna LM, Schnitker SA, VanHarn K, Carter J. Spiritual struggles and mental health outcomes in a spiritually integrated inpatient program. J Affect Disord. 2019 Apr 15;249:127-135. doi: 10.1016/j.jad.2019.02.012. Epub 2019 Feb 6.
Results Reference
background
PubMed Identifier
30218372
Citation
Naimi E, Eilami O, Babuei A, Rezaei K, Moslemirad M. The Effect of Religious Intervention Using Prayer for Quality of Life and Psychological Status of Patients with Permanent Pacemaker. J Relig Health. 2020 Apr;59(2):920-927. doi: 10.1007/s10943-018-0698-8.
Results Reference
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PubMed Identifier
3393937
Citation
Byrd RC. Positive therapeutic effects of intercessory prayer in a coronary care unit population. South Med J. 1988 Jul;81(7):826-9. doi: 10.1097/00007611-198807000-00005.
Results Reference
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PubMed Identifier
10547166
Citation
Harris WS, Gowda M, Kolb JW, Strychacz CP, Vacek JL, Jones PG, Forker A, O'Keefe JH, McCallister BD. A randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit. Arch Intern Med. 1999 Oct 25;159(19):2273-8. doi: 10.1001/archinte.159.19.2273. Erratum In: Arch Intern Med 2000 Jun 26;160(12):1878.
Results Reference
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PubMed Identifier
15735569
Citation
Lakkireddy D, Vacek J, Harris W, Gowda M, Pendyala K, Murray C. Modified Mid America Heart Institute Coronary Care Unit scoring system--a new comprehensive prognostic index for Coronary Care Unit patients. Med Sci Monit. 2005 Mar;11(3):CR95-9.
Results Reference
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PubMed Identifier
29525785
Citation
Jentzer JC, Bennett C, Wiley BM, Murphree DH, Keegan MT, Gajic O, Wright RS, Barsness GW. Predictive Value of the Sequential Organ Failure Assessment Score for Mortality in a Contemporary Cardiac Intensive Care Unit Population. J Am Heart Assoc. 2018 Mar 10;7(6):e008169. doi: 10.1161/JAHA.117.008169.
Results Reference
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PubMed Identifier
29621337
Citation
Yoon JC, Kim YJ, Lee YJ, Ryoo SM, Sohn CH, Seo DW, Lee YS, Lee JH, Lim KS, Kim WY. Serial evaluation of SOFA and APACHE II scores to predict neurologic outcomes of out-of-hospital cardiac arrest survivors with targeted temperature management. PLoS One. 2018 Apr 5;13(4):e0195628. doi: 10.1371/journal.pone.0195628. eCollection 2018.
Results Reference
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PubMed Identifier
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Citation
Yang Y, Peng F, Wang R, Yange M, Guan K, Jiang T, Xu G, Sun J, Chang C. The deadly coronaviruses: The 2003 SARS pandemic and the 2020 novel coronavirus epidemic in China. J Autoimmun. 2020 May;109:102434. doi: 10.1016/j.jaut.2020.102434. Epub 2020 Mar 3. Erratum In: J Autoimmun. 2020 Jul;111:102487.
Results Reference
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The COVID-19 ICU PRAYER Study
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