The COVID-19 ICU PRAYER Study

Coronavirus Infection Clinical Trial

Official title:

Impact of Multi-Denominational Prayer on Morbidity and Mortality of Patients Admitted to the Intensive Care Unite With Corona Virus Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04361838
• Other study ID #: Covid Prayer Study
• Status: Terminated
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2021
• Source: Kansas City Heart Rhythm Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Infections

Intervention

Behavioral:
• prayer
receive prayers daily while in ICU

Locations

Country	Name	City	State
United States	Research Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Institute

Country where clinical trial is conducted

United States, 

References & Publications (10)

Byrd RC. Positive therapeutic effects of intercessory prayer in a coronary care unit population. South Med J. 1988 Jul;81(7):826-9. — View 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. — View 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. Erratum in: Arch Intern Med 2000 Jun 26;160(12):1878. — View 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). pii: e008169. doi: 10.1161/JAHA.117.008169. — View 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. — View 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. — View 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. — View 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. — View 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. Review. Erratum in: J Autoimmun. 2020 Jul;111:102487. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Secondary	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.	daily until patient recovers and moves out of ICU or exits the study, up to 30 days.
Secondary	Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score	The higher the SOFA score the increased likelihood of organ failure.	daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Secondary	Difference in patient outcomes - Length of stay in ICU.	A prolonged length of time in ICU increases mortality.	daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Secondary	Difference in patient outcomes - Length of ventilator support	A prolonged length of time with ventilator support increases mortality.	daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Secondary	Difference in patient outcomes - length of vasopressor support	A prolonged length of time with vasopressor support increases recovery time.	daily until patient recovers and moves out of ICU or exits the study, up to 30 days