MoralsXPHI-COVID19NCT04542122
Moral Judgements and Choices of Caregivers in the Time of COVID-19 Pandemic
A study testing Choices and judgements in people with Morals, run by University Hospital, Caen.
Trial summary
The XPHI-COVID19 randomized study aims to investigate the mechanisms of moral judgements in a population of caregivers, using a survey, with the results to the Oxford Utilitarianism Scale as primary outcome. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Morals
- What is being tested?
- Choices and judgements
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2020to 2 Aug 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All caregivers from french public healthcare center with Intensive Care Unit
- Agreement
Who cannot join
- Refuse to participate or withdraw agreement
Trial locations and contacts
No sites are listed yet.
Florian COVA, PhD contact
About this study
Official title: Moral Judgements and Choices of Caregivers in the Time of COVID-19 Pandemic: a Randomized Experimental Study
The XPHI-COVID19 randomized study aims to investigate the mechanisms of moral judgements in a population of caregivers, using a survey, with the results to the Oxford Utilitarianism Scale as primary outcome.
- Conditions
- Morals
- Being tested
- Choices and judgements
- Keywords
- morals, ethics, moral judgements, moral choices, covid 19, survey, utilitarianism, deontology, oxford utilitarianism scale
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choices and judgementsBehavioural
In the intervention arm, the participant is asked to answer clinical cases in a reverse order from the control group (control has to make moral choices then judge somebody else's choices ; intervention has to judge moral choices first, then make his own)
| Study group | Role | What they receive |
|---|---|---|
| Choices then judgements | No intervention | Not described |
| Judgements then choices | Active comparator | Switch in the order of clinical cases in the survey Receives: Behavioral: Choices and judgements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Utilitarianism Scale
Two-Dimensional Model of Utilitarian Psychology
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start3 Sep 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion2 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MoralsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Sponsor
- Investigators
- Clement GAKUBA, MD PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542122
- Sponsor's protocol ID
- 1474
- Acronym
- XPHI-COVID19
- Status last verified
- Jul 2020
- First submitted
- 31 Aug 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kahane G, Everett JAC, Earp BD, Caviola L, Faber NS, Crockett MJ, Savulescu J. Beyond sacrificial harm: A two-dimensional model of utilitarian psychology. Psychol Rev. 2018 Mar;125(2):131-164. doi: 10.1037/rev0000093. Epub 2017 Dec 21.
PubMed 29265854Garbutt G, Davies P. Should the practice of medicine be a deontological or utilitarian enterprise? J Med Ethics. 2011 May;37(5):267-70. doi: 10.1136/jme.2010.036111. Epub 2011 Jan 29.
PubMed 21278402Conway P, Goldstein-Greenwood J, Polacek D, Greene JD. Sacrificial utilitarian judgments do reflect concern for the greater good: Clarification via process dissociation and the judgments of philosophers. Cognition. 2018 Oct;179:241-265. doi: 10.1016/j.cognition.2018.04.018. Epub 2018 Jul 2.
PubMed 30064654Einav S, Benoit DD. Focus on ethics of admission and discharge policies and conflicts of interest. Intensive Care Med. 2019 Aug;45(8):1130-1132. doi: 10.1007/s00134-019-05673-3. Epub 2019 Jul 2. No abstract available.
PubMed 31267194Emanuel EJ, Persad G, Upshur R, Thome B, Parker M, Glickman A, Zhang C, Boyle C, Smith M, Phillips JP. Fair Allocation of Scarce Medical Resources in the Time of Covid-19. N Engl J Med. 2020 May 21;382(21):2049-2055. doi: 10.1056/NEJMsb2005114. Epub 2020 Mar 23. No abstract available.
PubMed 32202722Truog RD, Mitchell C, Daley GQ. The Toughest Triage - Allocating Ventilators in a Pandemic. N Engl J Med. 2020 May 21;382(21):1973-1975. doi: 10.1056/NEJMp2005689. Epub 2020 Mar 23. No abstract available.
PubMed 32202721Leclerc T, Donat N, Donat A, Pasquier P, Libert N, Schaeffer E, D'Aranda E, Cotte J, Fontaine B, Perrigault PF, Michel F, Muller L, Meaudre E, Veber B. Prioritisation of ICU treatments for critically ill patients in a COVID-19 pandemic with scarce resources. Anaesth Crit Care Pain Med. 2020 Jun;39(3):333-339. doi: 10.1016/j.accpm.2020.05.008. Epub 2020 May 17.
PubMed 32426441Rosenbaum L. Facing Covid-19 in Italy - Ethics, Logistics, and Therapeutics on the Epidemic's Front Line. N Engl J Med. 2020 May 14;382(20):1873-1875. doi: 10.1056/NEJMp2005492. Epub 2020 Mar 18. No abstract available.
PubMed 32187459
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moral Judgements and Choices of Caregivers in the Time of COVID-19 Pandemic: a Randomized Experimental Study
- ClinicalTrials.gov ID
- NCT04542122
- Acronym / sponsor ID
- XPHI-COVID19 / 1474
- Conditions
- Morals
- Keywords
- morals, ethics, moral judgements, moral choices, covid 19, survey, utilitarianism, deontology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- 3 Sep 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 2 Aug 2021 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The XPHI-COVID19 randomized study aims to investigate the mechanisms of moral judgements in a population of caregivers, using a survey, with the results to the Oxford Utilitarianism Scale as primary outcome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Choices then judgements | No intervention | – |
| Judgements then choices | Active comparator | Behavioral: Choices and judgementsSwitch in the order of clinical cases in the survey |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All caregivers from french public healthcare center with Intensive Care Unit
- Agreement
Key exclusion criteria (1 listed)
- Refuse to participate or withdraw agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choices and judgementsIn the intervention arm, the participant is asked to answer clinical cases in a reverse order from the control group (control has to make moral choices then judge somebody else's choices ; intervention has to judge moral choices first, then make his own) | Behavioural | Judgements then choices |
Primary outcome
Oxford Utilitarianism Scale
Time frame: Up to one year
Two-Dimensional Model of Utilitarian Psychology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 29265854Kahane G, Everett JAC, Earp BD, Caviola L, Faber NS, Crockett MJ, Savulescu J. Beyond sacrificial harm: A two-dimensional model of utilitarian psychology. Psychol Rev. 2018 Mar;125(2):131-164. doi: 10.1037/rev0000093. Epub 2017 Dec 21.
- Background: PubMed 21278402Garbutt G, Davies P. Should the practice of medicine be a deontological or utilitarian enterprise? J Med Ethics. 2011 May;37(5):267-70. doi: 10.1136/jme.2010.036111. Epub 2011 Jan 29.
- Background: PubMed 30064654Conway P, Goldstein-Greenwood J, Polacek D, Greene JD. Sacrificial utilitarian judgments do reflect concern for the greater good: Clarification via process dissociation and the judgments of philosophers. Cognition. 2018 Oct;179:241-265. doi: 10.1016/j.cognition.2018.04.018. Epub 2018 Jul 2.
- Background: PubMed 31267194Einav S, Benoit DD. Focus on ethics of admission and discharge policies and conflicts of interest. Intensive Care Med. 2019 Aug;45(8):1130-1132. doi: 10.1007/s00134-019-05673-3. Epub 2019 Jul 2. No abstract available.
- Background: PubMed 32202722Emanuel EJ, Persad G, Upshur R, Thome B, Parker M, Glickman A, Zhang C, Boyle C, Smith M, Phillips JP. Fair Allocation of Scarce Medical Resources in the Time of Covid-19. N Engl J Med. 2020 May 21;382(21):2049-2055. doi: 10.1056/NEJMsb2005114. Epub 2020 Mar 23. No abstract available.
- Background: PubMed 32202721Truog RD, Mitchell C, Daley GQ. The Toughest Triage - Allocating Ventilators in a Pandemic. N Engl J Med. 2020 May 21;382(21):1973-1975. doi: 10.1056/NEJMp2005689. Epub 2020 Mar 23. No abstract available.
- Background: PubMed 32426441Leclerc T, Donat N, Donat A, Pasquier P, Libert N, Schaeffer E, D'Aranda E, Cotte J, Fontaine B, Perrigault PF, Michel F, Muller L, Meaudre E, Veber B. Prioritisation of ICU treatments for critically ill patients in a COVID-19 pandemic with scarce resources. Anaesth Crit Care Pain Med. 2020 Jun;39(3):333-339. doi: 10.1016/j.accpm.2020.05.008. Epub 2020 May 17.
- Background: PubMed 32187459Rosenbaum L. Facing Covid-19 in Italy - Ethics, Logistics, and Therapeutics on the Epidemic's Front Line. N Engl J Med. 2020 May 14;382(20):1873-1875. doi: 10.1056/NEJMp2005492. Epub 2020 Mar 18. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian COVA, PhD contact
Clement GAKUBA, MD PhD principal investigator
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
A study testing Choices and judgements in people with Morals, run by University Hospital, Caen.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clement GAKUBA, MD PhD (+33231064736, gakuba-c@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Utilitarianism Scale (time frame: Up to one year). 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 NCT04542122, which also lists 8 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 9 Sep 2020.