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Coronavirus InfectionNCT04361838

The COVID-19 ICU PRAYER Study

A study testing prayer in people with Coronavirus Infection, run by Kansas City Heart Rhythm Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 110 years
Conditions the study is for
Coronavirus Infection
What is being tested?
prayer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
21 May 2020to 30 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Medical Center

    Kansas City, Missouri, 64132

Other trials in United States

About this study

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

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.

Being tested
prayer
Medical subject headings
Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prayerBehavioural

    receive prayers daily while in ICU

Study groups in NCT04361838
Study groupRoleWhat they receive
PrayerActive comparatorPatients will receive a daily prayer and standard of care treatment from multi-denominational group while in the ICU.
Receives: Behavioral: prayer
No PrayerNo interventionPatients will receive standard of care treatment while in the ICU.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Secondary outcomes (5)

  1. 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.

    Measured: daily until patient recovers and moves out of ICU or exits the study, up to 30 days.

  2. Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score

    The higher the SOFA score the increased likelihood of organ failure.

    Measured: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

  3. Difference in patient outcomes - Length of stay in ICU.

    A prolonged length of time in ICU increases mortality.

    Measured: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

  4. Difference in patient outcomes - Length of ventilator support

    A prolonged length of time with ventilator support increases mortality.

    Measured: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

  5. Difference in patient outcomes - length of vasopressor support

    A prolonged length of time with vasopressor support increases recovery time.

    Measured: daily until patient recovers and moves out of ICU or exits the study, up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start21 May 2020
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

Why it stopped: Due to the low enrollment, this study is closed. Analysis of data is not performed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04361838
Sponsor's protocol ID
Covid Prayer Study
Status last verified
Feb 2021
First submitted
16 Apr 2020
Last updated
3 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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. doi: 10.1176/ajp.149.12.1693.

    PubMed 1443246

  • 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.

    PubMed 9724889

  • 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.

    PubMed 30772739

  • 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.

    PubMed 30218372

  • 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.

    PubMed 3393937

  • 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.

    PubMed 10547166

  • 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.

    PubMed 15735569

  • 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.

    PubMed 29525785

  • 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.

    PubMed 29621337

  • 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.

    PubMed 32143990

Questions about this trial

What is this clinical trial studying?

A study testing prayer in people with Coronavirus Infection, run by Kansas City Heart Rhythm Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to the low enrollment, this study is closed. Analysis of data is not performed.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04361838, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.

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