The COVID-19 ICU PRAYER Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Prayer Patients will receive a daily prayer and standard of care treatment from multi-denominational group while in the ICU. |
Behavioral: prayer
receive prayers daily while in ICU
|
| No Intervention: No Prayer Patients will receive standard of care treatment while in the ICU. |
Outcome Measures
Primary Outcome Measures
- Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality. [daily until patient recovers and moves out of ICU or exits the study, up to 30 days]
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. [daily until patient recovers and moves out of ICU or exits the study, up to 30 days.]
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 [daily until patient recovers and moves out of ICU or exits the study, up to 30 days]
The higher the SOFA score the increased likelihood of organ failure.
- Difference in patient outcomes - Length of stay in ICU. [daily until patient recovers and moves out of ICU or exits the study, up to 30 days]
A prolonged length of time in ICU increases mortality.
- Difference in patient outcomes - Length of ventilator support [daily until patient recovers and moves out of ICU or exits the study, up to 30 days]
A prolonged length of time with ventilator support increases mortality.
- Difference in patient outcomes - length of vasopressor support [daily until patient recovers and moves out of ICU or exits the study, up to 30 days]
A prolonged length of time with vasopressor support increases recovery time.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
Sponsors and Collaborators
- Kansas City Heart Rhythm Institute
Investigators
- Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Byrd RC. Positive therapeutic effects of intercessory prayer in a coronary care unit population. South Med J. 1988 Jul;81(7):826-9.
- 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.
- 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. Erratum in: Arch Intern Med 2000 Jun 26;160(12):1878.
- 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). pii: e008169. doi: 10.1161/JAHA.117.008169.
- 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.
- 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.
- 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.
- 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.
- 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. Review. Erratum in: J Autoimmun. 2020 Jul;111:102487.
- 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.
- Covid Prayer Study