- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825862
Investigating Affective Attitude Question-behaviour Effects on Intention to Become an Organ Donor
March 26, 2019 updated by: Royal College of Surgeons, Ireland
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
999
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Karnataka
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Manipal, Karnataka, India, 576104
- Manipal University
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Dublin, Ireland, D2
- RCSI
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Serdang
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Perdana, Serdang, Malaysia, 43400
- RCSI Perdana University
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Stirling, United Kingdom, FK9 4LA
- University of Stirling
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Agree to participate
Exclusion Criteria:
- Refuse to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Replication group
Replication group - this group will complete the entire questionnaire, in order to replicate the findings of O'Carroll et al (2011)
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Active Comparator: Omit 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.
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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).
Other Names:
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Active Comparator: Omit negatively-worded items
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.
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intention to become an organ donor
Time Frame: within 3 months
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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?"
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within 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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))
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"Did survey participant accept a donor card?" Yes/No
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Immediately at the end of the interview (i.e. that day, an average of 10-15 minutes after consenting to participate))
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frank Doyle, PhD, Royal College of Surgeons in Ireland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
June 14, 2016
First Submitted That Met QC Criteria
July 6, 2016
First Posted (Estimate)
July 7, 2016
Study Record Updates
Last Update Posted (Actual)
March 27, 2019
Last Update Submitted That Met QC Criteria
March 26, 2019
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- REC1048b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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