NCT02825862

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 27, 2019

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

June 14, 2016

Last Update Submit

March 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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?"

    within 3 months

Secondary Outcomes (1)

  • Taking a donor card after the interview

    Immediately at the end of the interview (i.e. that day, an average of 10-15 minutes after consenting to participate))

Study Arms (3)

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.

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.

Behavioral: Question-behaviour effect (negatively-worded attitudes)

Interventions

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).

Also known as: Priming
Omit affective attitudes

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).

Also known as: Priming
Omit negatively-worded items

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Agree to participate

You may not qualify if:

  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Manipal University

Manipal, Karnataka, 576104, India

Location

RCSI

Dublin, D2, Ireland

Location

RCSI Perdana University

Perdana, Serdang, 43400, Malaysia

Location

University of Stirling

Stirling, FK9 4LA, United Kingdom

Location

Study Officials

  • Frank Doyle, PhD

    Royal College of Surgeons in Ireland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

July 7, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

March 27, 2019

Record last verified: 2018-04

Locations