NCT04361838

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

May 21, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

April 16, 2020

Last Update Submit

February 1, 2022

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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.

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Prayer

ACTIVE COMPARATOR

Patients will receive a daily prayer and standard of care treatment from multi-denominational group while in the ICU.

Behavioral: prayer

No Prayer

NO INTERVENTION

Patients will receive standard of care treatment while in the ICU.

Interventions

prayerBEHAVIORAL

receive prayers daily while in ICU

Prayer

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female greater than 18 years of age
  • Confirmed positive for COVID-19
  • Patient admitted to Intensive Care Unit

You may not qualify if:

  • Patients admitted to ICU for diagnosis that is not COVID-19 positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Related Publications (10)

  • 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.

    PMID: 1443246BACKGROUND

  • 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.

    PMID: 9724889BACKGROUND

  • 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.

    PMID: 30772739BACKGROUND

  • 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.

    PMID: 30218372BACKGROUND

  • 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.

    PMID: 3393937BACKGROUND

  • 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.

    PMID: 10547166BACKGROUND

  • 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.

    PMID: 15735569BACKGROUND

  • 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.

    PMID: 29525785BACKGROUND

  • 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.

    PMID: 29621337BACKGROUND

  • 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.

    PMID: 32143990BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Faith Healing

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Spiritual TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Dhanunjaya Lakkireddy, MD

    Kansas City Heart Rhythm Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 24, 2020

Study Start

May 21, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

February 3, 2022

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)