Organ DonationNCT02825862
Investigating Affective Attitude Question-behaviour Effects on Intention to Become an Organ Donor
A study testing Question-behaviour effect (for affective attitudes) and Question-behaviour effect (negatively-worded attitudes) in people with Organ Donation, run by Royal College of Surgeons, Ireland at 4 sites in 4 countries.
Trial summary
The investigators aim to experimentally manipulate presence of questions on positive or negative affective attitudes to see if including these moderate as intention to become an organ donor. The methodology will be replicated across three international sites (RCSI Dublin, RCSI Bahrain, RCSI Perdana University). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Organ Donation
- What is being tested?
- Question-behaviour effect (for affective attitudes) and Question-behaviour effect (negatively-worded attitudes)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 999 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2016to Apr 2018
- 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
- Agree to participate
Who cannot join
- Refuse to participate
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Circumventing the 'Ick' Factor: a Multi-site Randomised Trial of the Effects of Omitting Affective Attitudes to Increase Intention to Become an Organ Donor
The investigators aim to experimentally manipulate presence of questions on positive or negative affective attitudes to see if including these moderate as intention to become an organ donor. The methodology will be replicated across three international sites (RCSI Dublin, RCSI Bahrain, RCSI Perdana University).
- Conditions
- Organ Donation
- Being tested
- Question-behaviour effect (for affective attitudes), Question-behaviour effect (negatively-worded attitudes)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Question-behaviour effect (for affective attitudes)Behavioural
Also called Priming
Investigators propose to investigate the Question-behaviour effect (omit affective attitudes). Investigators will conduct an experimental manipulation by omitting certain items from a questionnaire assessing attitudes to organ donation. Specifically, investigators will omit questions on affective attitudes. This group will complete a similar questionnaire to the comparison group, with the same number of items, but items on affective attitudes will substituted for non-affective items (e.g. on political parties).
Question-behaviour effect (negatively-worded attitudes)Behavioural
Also called Priming
Behavioral: Question-behaviour effect (for negatively-worded attitudes) Investigators propose to investigate the Question-behaviour effect (omit negatively-worded affective attitudes). Investigators will conduct an experimental manipulation by omitting certain items from a questionnaire assessing attitudes to organ donation. Specifically, investigators will omit questions on negatively-worded affective attitudes. This group will complete a similar questionnaire to the comparison group, with the same number of items, but items on negatively-worded affective attitudes will substituted for non-affective items (e.g. on political parties).
| Study group | Role | What they receive |
|---|---|---|
| Replication group | No intervention | Replication group - this group will complete the entire questionnaire, in order to replicate the findings of O'Carroll et al (2011) |
| Omit affective attitudes | Active comparator | Omitting affective attitudes The intervention is the omission of all questions on affective attitudes. This group will complete a similar questionnaire to the replication group, with the same number of questionnaire items, but affective attitudes will be omitted. Dummy questions (e.g. about politics) will be substituted for these deleted questions. Receives: Behavioral: Question-behaviour effect (for affective attitudes) |
| Omit negatively-worded items | Active comparator | Omitting negatively-worded affective attitudes. This intervention is the omission of a subset of negatively-worded affective attitudinal items. This group will complete a similar questionnaire to the replication group, with the same number of items, but all negatively-worded affective attitudes will be omitted. Dummy questions (e.g. about politics) will be substituted for these deleted questions. Receives: Behavioral: Question-behaviour effect (negatively-worded attitudes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to become an organ donor
Mean score of two 7-point items: "I will definitely sign up for organ donation and discuss this with my family in the next few months" and "How strong is your intention to sign up for organ donation and discuss this with my family in the next few months?"
Measured: within 3 months
Secondary outcomes (1)
Taking a donor card after the interview
"Did survey participant accept a donor card?" Yes/No
Measured: Immediately at the end of the interview (i.e. that day, an average of 10-15 minutes after consenting to participate))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ DonationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stirling, Manipal University
- Responsible party
- Sponsor
- Investigators
- Frank Doyle, PhD, Principal investigator, Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825862
- Sponsor's protocol ID
- REC1048b
- Status last verified
- Apr 2018
- First submitted
- 14 Jun 2016
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumventing the 'Ick' Factor: a Multi-site Randomised Trial of the Effects of Omitting Affective Attitudes to Increase Intention to Become an Organ Donor
- ClinicalTrials.gov ID
- NCT02825862
- Acronym / sponsor ID
- REC1048b
- Conditions
- Organ Donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- University of Stirling, Manipal University
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 7 Jul 2016 (estimated)
- 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 investigators aim to experimentally manipulate presence of questions on positive or negative affective attitudes to see if including these moderate as intention to become an organ donor. The methodology will be replicated across three international sites (RCSI Dublin, RCSI Bahrain, RCSI Perdana University).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Replication group | No intervention | –Replication group - this group will complete the entire questionnaire, in order to replicate the findings of O'Carroll et al (2011) |
| Omit affective attitudes | Active comparator | Behavioral: Question-behaviour effect (for affective attitudes)Omitting affective attitudes The intervention is the omission of all questions on affective attitudes. This group will complete a similar questionnaire to the replication group, with the same number of questionnaire items, but affective attitudes will be omitted. Dummy questions (e.g. about politics) will be substituted for these deleted questions. |
| Omit negatively-worded items | Active comparator | Behavioral: Question-behaviour effect (negatively-worded attitudes)Omitting negatively-worded affective attitudes. This intervention is the omission of a subset of negatively-worded affective attitudinal items. This group will complete a similar questionnaire to the replication group, with the same number of items, but all negatively-worded affective attitudes will be omitted. Dummy questions (e.g. about politics) will be substituted for these deleted questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Agree to participate
Key exclusion criteria (1 listed)
- Refuse to participate
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 |
|---|---|---|
| Question-behaviour effect (for affective attitudes)Also: PrimingInvestigators propose to investigate the Question-behaviour effect (omit affective attitudes). Investigators will conduct an experimental manipulation by omitting certain items from a questionnaire assessing attitudes to organ donation. Specifically, investigators will omit questions on affective attitudes. This group will complete a similar questionnaire to the comparison group, with the same number of items, but items on affective attitudes will substituted for non-affective items (e.g. on political parties). | Behavioural | Omit affective attitudes |
| Question-behaviour effect (negatively-worded attitudes)Also: PrimingBehavioral: Question-behaviour effect (for negatively-worded attitudes) Investigators propose to investigate the Question-behaviour effect (omit negatively-worded affective attitudes). Investigators will conduct an experimental manipulation by omitting certain items from a questionnaire assessing attitudes to organ donation. Specifically, investigators will omit questions on negatively-worded affective attitudes. This group will complete a similar questionnaire to the comparison group, with the same number of items, but items on negatively-worded affective attitudes will substituted for non-affective items (e.g. on political parties). | Behavioural | Omit negatively-worded items |
Primary outcome
Intention to become an organ donor
Time frame: within 3 months
Mean score of two 7-point items: "I will definitely sign up for organ donation and discuss this with my family in the next few months" and "How strong is your intention to sign up for organ donation and discuss this with my family in the next few months?"
1 secondary outcome
Taking a donor card after the interview
Time frame: Immediately at the end of the interview (i.e. that day, an average of 10-15 minutes after consenting to participate))
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 27 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Organ Donation
Not yet recruitingObservational study
Brain-based Prediction of the Dying Duration in Humans After Withdrawal of Life Sustaining Therapies to Inform Donation After Circulatory Death
Organ Donation After Circulatory Death
Not yet recruiting
Improving Deceased Organ Donation and Transplantation Using the Donation Advisor Clinical Decision Support Tool
Organ Donation After Circulatory Death, Organ Donation
RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Active, not recruitingPhase 3
Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
Influenza (Pandemic), Avian Influenza
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.
Frank Doyle, PhD principal investigator
Royal College of Surgeons in Ireland
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Question-behaviour effect (for affective attitudes) and Question-behaviour effect (negatively-worded attitudes) in people with Organ Donation, run by Royal College of Surgeons, Ireland at 4 sites in 4 countries.
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 1 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 27 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 4 sites in India, Ireland, Malaysia, United Kingdom. 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?
Intention to become an organ donor (time frame: within 3 months). 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 27 Mar 2019.