The COVID-19 ICU PRAYER Study

• ClinicalTrials.gov Identifier: NCT04361838
• Recruitment Status: Terminated
• First Posted: April 24, 2020
• Last Update Posted: February 3, 2022
• Sponsor: Kansas City Heart Rhythm Institute
• Information provided by (Responsible Party): Kansas City Heart Rhythm Institute

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
Coronavirus Infection	Behavioral: prayer	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Impact of Multi-Denominational Prayer on Morbidity and Mortality of Patients Admitted to the Intensive Care Unite With Corona Virus Infection
• Actual Study Start Date: May 21, 2020
• Actual Primary Completion Date: April 30, 2021
• Actual Study Completion Date: April 30, 2021

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 :

1. Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality. [ Time Frame: 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 :

1. Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score. [ Time Frame: 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.
2. Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score [ Time Frame: 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.
3. Difference in patient outcomes - Length of stay in ICU. [ Time Frame: 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.
4. Difference in patient outcomes - Length of ventilator support [ Time Frame: 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.
5. Difference in patient outcomes - length of vasopressor support [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 110 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

United States, Missouri

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

More Information

Publications:

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.

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.

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.

Byrd RC. Positive therapeutic effects of intercessory prayer in a coronary care unit population. South Med J. 1988 Jul;81(7):826-9.

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.

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.

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.

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.

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.

• Responsible Party: Kansas City Heart Rhythm Institute
• ClinicalTrials.gov Identifier: NCT04361838
• Other Study ID Numbers: Covid Prayer Study
• First Posted: April 24, 2020
• Last Update Posted: February 3, 2022
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases