Living Organ DonationNCT04443114
Informing American Muslims About Living Donation
A study testing Organ Donation Workshop and End of Life Care Workshop in people with Living Organ Donation, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this projects is to test the effectiveness of a tailored educational intervention in increasing knowledge about organ donation among Muslim Americans. More specifically, using the theory of planned behavior (TPB) as a conceptual framework, the workshop's goal is to enhance attendee knowledge of the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Living Organ Donation
- What is being tested?
- Organ Donation Workshop and End of Life Care Workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 3 Aug 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified Muslim men and women
- Fluent in English
- Adult
- Availability to attend workshop sessions
Who cannot join
- No personal or immediate family history of organ transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Feasibility of Peer-Led Educational Workshops on Increasing Awareness Among American Muslims About Living Donation in Mosque Communities
The purpose of this projects is to test the effectiveness of a tailored educational intervention in increasing knowledge about organ donation among Muslim Americans. More specifically, using the theory of planned behavior (TPB) as a conceptual framework, the workshop's goal is to enhance attendee knowledge of the benefits and risks (behavioral beliefs and attitude), understanding of religious arguments for and against (normative beliefs and subjective norm), and procedural knowledge about the process and types of (control beliefs and perceived control) living organ donation.
Read the detailed description
The study consists of two workshops (control and experimental) and an optional follow-up interview.
The study contains 2 intervention arms based on the order in which the organ donation workshop is delivered at the mosque: early and late. The early arm will receive the experimental organ donation workshop first, followed by the control workshop (on end-of-life care). The late arm will receive the workshops in the opposite order (end-of-life care workshop followed by the organ donation workshop).
To address varied adult learning styles, the workshops will incorporate didactic teaching, moderated panel presentations, and facilitated small group discussions led by a trained peer educator. Workshops will also involve self-administered surveys.
- Conditions
- Living Organ Donation
- Being tested
- Organ Donation Workshop, End of Life Care Workshop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organ Donation WorkshopOther
Also called Experimental
Discussion Moderated by Peer Educators Didactic Session 1: Biomedical Aspects of Living Donation Didactic Session 2: Organ Donation and Transplantation in the US- Statistics and Procedures Moderated Debate: Living Organ Donation: Halal or Haram? Facilitated Group Discussions with Peer Educators
End of Life Care WorkshopOther
Also called Control
Discussion Moderated by Peer Educators Didactic Session 1: Critical Theological Concepts about Sickness and Health in Islamic Bioethics Didactic Session 2: Islamic Rulings about Brain Death, and Withdrawing/Withholding Life Support Moderated Panel Discussion: End-of-life Decision Making Facilitated Group Discussions with Peer Educators
| Study group | Role | What they receive |
|---|---|---|
| Early Arm | Other | The early arm will receive the experimental organ donation workshop first, followed by the control workshop on end-of-life care. Receives: Other: Organ Donation Workshop; Other: End of Life Care Workshop |
| Late Arm | Other | The late arm will receive the control workshop on end-of-life care first, followed by the experimental organ donation workshop. Receives: Other: Organ Donation Workshop; Other: End of Life Care Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Islamic knowledge of living organ donation
Islamic Knowledge of Living Donation [IK-LOD] Scale
Measured: 2 weeks
Change in living organ donation knowledge
Living Donation subscale of the Rotterdam Renal Transplant Knowledge Test (R3K-T)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start10 Oct 2018
- Primary completion3 Aug 2019
- Study completion3 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Living Organ DonationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Quinn, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443114
- Sponsor's protocol ID
- IRB18-1378
- Status last verified
- Oct 2020
- First submitted
- 19 Jun 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Padela AI, Duivenbode R, Saunders MR, Quinn M, Koh E. The impact of religiously tailored and ethically balanced education on intention for living organ donation among Muslim Americans. Clin Transplant. 2020 Dec;34(12):e14111. doi: 10.1111/ctr.14111. Epub 2020 Nov 1.
PubMed 33063912Padela AI, Duivenbode R, Quinn M, Saunders MR. Informing American Muslims about living donation through tailored health education: A randomized controlled crossover trial evaluating increase in biomedical and religious knowledge. Am J Transplant. 2021 Mar;21(3):1227-1237. doi: 10.1111/ajt.16242. Epub 2020 Sep 15.
PubMed 32772460
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Peer-Led Educational Workshops on Increasing Awareness Among American Muslims About Living Donation in Mosque Communities
- ClinicalTrials.gov ID
- NCT04443114
- Acronym / sponsor ID
- IRB18-1378
- Conditions
- Living Organ Donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 3 Aug 2019 (actual)
- Study completion
- 3 Aug 2019 (actual)
- First posted
- 23 Jun 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 purpose of this projects is to test the effectiveness of a tailored educational intervention in increasing knowledge about organ donation among Muslim Americans. More specifically, using the theory of planned behavior (TPB) as a conceptual framework, the workshop's goal is to enhance attendee knowledge of the benefits and risks (behavioral beliefs and attitude), understanding of religious arguments for and against (normative beliefs and subjective norm), and procedural knowledge about the process and types of (control beliefs and perceived control) living organ donation.
Detailed description
The study consists of two workshops (control and experimental) and an optional follow-up interview.
The study contains 2 intervention arms based on the order in which the organ donation workshop is delivered at the mosque: early and late. The early arm will receive the experimental organ donation workshop first, followed by the control workshop (on end-of-life care). The late arm will receive the workshops in the opposite order (end-of-life care workshop followed by the organ donation workshop).
To address varied adult learning styles, the workshops will incorporate didactic teaching, moderated panel presentations, and facilitated small group discussions led by a trained peer educator. Workshops will also involve self-administered surveys.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Arm | Other | Other: Organ Donation Workshop, Other: End of Life Care WorkshopThe early arm will receive the experimental organ donation workshop first, followed by the control workshop on end-of-life care. |
| Late Arm | Other | Other: Organ Donation Workshop, Other: End of Life Care WorkshopThe late arm will receive the control workshop on end-of-life care first, followed by the experimental organ donation workshop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identified Muslim men and women
- Fluent in English
- Adult
- Availability to attend workshop sessions
Key exclusion criteria (1 listed)
- No personal or immediate family history of organ transplant
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 |
|---|---|---|
| Organ Donation WorkshopAlso: ExperimentalDiscussion Moderated by Peer Educators Didactic Session 1: Biomedical Aspects of Living Donation Didactic Session 2: Organ Donation and Transplantation in the US- Statistics and Procedures Moderated Debate: Living Organ Donation: Halal or Haram? Facilitated Group Discussions with Peer Educators | Other | Early Arm, Late Arm |
| End of Life Care WorkshopAlso: ControlDiscussion Moderated by Peer Educators Didactic Session 1: Critical Theological Concepts about Sickness and Health in Islamic Bioethics Didactic Session 2: Islamic Rulings about Brain Death, and Withdrawing/Withholding Life Support Moderated Panel Discussion: End-of-life Decision Making Facilitated Group Discussions with Peer Educators | Other | Early Arm, Late Arm |
Primary outcome
Change in Islamic knowledge of living organ donation
Time frame: 2 weeks
Islamic Knowledge of Living Donation [IK-LOD] Scale
Change in living organ donation knowledge
Time frame: 2 weeks
Living Donation subscale of the Rotterdam Renal Transplant Knowledge Test (R3K-T)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 33063912Padela AI, Duivenbode R, Saunders MR, Quinn M, Koh E. The impact of religiously tailored and ethically balanced education on intention for living organ donation among Muslim Americans. Clin Transplant. 2020 Dec;34(12):e14111. doi: 10.1111/ctr.14111. Epub 2020 Nov 1.
- Derived from this study: PubMed 32772460Padela AI, Duivenbode R, Quinn M, Saunders MR. Informing American Muslims about living donation through tailored health education: A randomized controlled crossover trial evaluating increase in biomedical and religious knowledge. Am J Transplant. 2021 Mar;21(3):1227-1237. doi: 10.1111/ajt.16242. Epub 2020 Sep 15.
- 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.
Michael Quinn, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organ Donation Workshop and End of Life Care Workshop in people with Living Organ Donation, run by University of Chicago 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 4 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: finished, as of the sponsor's last update on 19 Oct 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Islamic knowledge of living organ donation (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 NCT04443114, which also lists 2 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 19 Oct 2020.