ControlNCT03216213
Evaluating Attitudes Towards Organ Donation in Singapore
A study testing Frame and Norms in people with Control and Behavior, run by Yale-NUS College at 1 site in Singapore.
Trial summary
One survey is conducted. Exploring the effect of different messages on family members' decision making on organ donation. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- Frame and Norms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Sep 2018to 8 Feb 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above age 21
- Singapore Citizens and Permanent Residents
Who cannot join
- Below age 21
- Non-citizens
- Not able to make decisions for self
Trial locations and contacts
1 site in 1 country.
About this study
One survey is conducted. Exploring the effect of different messages on family members' decision making on organ donation.
Read the detailed description
The investigators intend to examine the impact of nudging interventions in the form of a vignette designed to emulate the standard procedure of informing family members of a loved one's unfavourable prognosis. The investigators intend to examine the effect of the interventions on the eventual decision-making process of the family member.
- Being tested
- Frame, Norms
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrameOther
Vignette is framed in a way that nudges participant to leave a legacy
NormsOther
Vignette informs the participant that most people choose an option to try to nudge participant into choosing that option as well
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Vignette contains no extra information |
| Frame | Experimental | Vignette is framed in a particular manner Receives: Other: Frame |
| Norms | Experimental | Vignette contains extra information about norms Receives: Other: Norms |
| All | Experimental | Vignette contains extra information about norms and is framed in a particular manner. Receives: Other: Frame; Other: Norms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary survey item - Preferred option for mother's situation
A binary choice between 'Turning off life support' and 'Wait and see' which measures the efficacy of nudges on ultimate decision-making.
Measured: 3 minutes
10cm line scale survey item - Willingness for participant's mother's organs to be donated under brain death
A 10cm line scale will be given and participants will be asked to put a cross on the line that corresponds to what they are feeling. This will measure their willingness for their mother's organs to be donated under the conditions of brain death.
Measured: 3 minutes
Secondary outcomes (2)
10cm line scale survey item - Willingness for participant's mother's organs to be donated under cardiac death
A 10cm line scale will be given and participants will be asked to put a cross on the line that corresponds to what they are feeling. This will measure their willingness for their mother's organs to be donated under the conditions of cardiac death.
Measured: 3 minutes
10cm line scale survey item - Willingness for participant's own organs to be donated under brain death
A 10cm line scale will be given and participants will be asked to put a cross on the line that corresponds to what they are feeling. This will measure their willingness to donate their own organs under conditions of brain death.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start27 Sep 2018
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ControlStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216213
- Sponsor's protocol ID
- HSS-1502-P02
- Status last verified
- Mar 2019
- First submitted
- 10 Jul 2017
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Attitudes Towards Organ Donation in Singapore
- ClinicalTrials.gov ID
- NCT03216213
- Acronym / sponsor ID
- HSS-1502-P02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 13 Jul 2017 (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.
One survey is conducted. Exploring the effect of different messages on family members' decision making on organ donation.
Detailed description
The investigators intend to examine the impact of nudging interventions in the form of a vignette designed to emulate the standard procedure of informing family members of a loved one's unfavourable prognosis. The investigators intend to examine the effect of the interventions on the eventual decision-making process of the family member.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Vignette contains no extra information |
| Frame | Experimental | Other: FrameVignette is framed in a particular manner |
| Norms | Experimental | Other: NormsVignette contains extra information about norms |
| All | Experimental | Other: Frame, Other: NormsVignette contains extra information about norms and is framed in a particular manner. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above age 21
- Singapore Citizens and Permanent Residents
Key exclusion criteria (3 listed)
- Below age 21
- Non-citizens
- Not able to make decisions for self
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 |
|---|---|---|
| FrameVignette is framed in a way that nudges participant to leave a legacy | Other | All, Frame |
| NormsVignette informs the participant that most people choose an option to try to nudge participant into choosing that option as well | Other | All, Norms |
Primary outcome
Binary survey item - Preferred option for mother's situation
Time frame: 3 minutes
A binary choice between 'Turning off life support' and 'Wait and see' which measures the efficacy of nudges on ultimate decision-making.
10cm line scale survey item - Willingness for participant's mother's organs to be donated under brain death
Time frame: 3 minutes
A 10cm line scale will be given and participants will be asked to put a cross on the line that corresponds to what they are feeling. This will measure their willingness for their mother's organs to be donated under the conditions of brain death.
2 secondary outcomes
10cm line scale survey item - Willingness for participant's mother's organs to be donated under cardiac death
Time frame: 3 minutes
10cm line scale survey item - Willingness for participant's own organs to be donated under brain death
Time frame: 3 minutes
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 8 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frame and Norms in people with Control and Behavior, run by Yale-NUS College at 1 site in Singapore.
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 3 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 8 Mar 2019. 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 Singapore. 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?
Binary survey item - Preferred option for mother's situation (time frame: 3 minutes). 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?
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 8 Mar 2019.