Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000690651
Ethics application status
Approved
Date submitted
23/06/2014
Date registered
1/07/2014
Date last updated
5/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of brief and enhanced information videos on increasing organ donor registration rates among TAFE students
Scientific title
Increasing organ donor registration rates among TAFE students: A cluster randomised controlled trial of brief and enhanced information videos
Secondary ID [1] 284843 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Organ Donation 292236 0
Condition category
Condition code
Public Health 292573 292573 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a three-arm cluster randomised controlled trial investigating the comparative effectiveness of two video interventions designed to increase registration on the Australian Organ Donor Register versus a control.

Brief video intervention: Classes allocated to the brief video intervention will be invited to complete a baseline survey investigating knowledge and attitudes towards organ donation as well as current organ donor registration status. Following this, organ donor registration forms will be distributed and a brief, 5-minute video delivering the “Discover, Decide, Discuss” message about organ donation will be screened. Students will then be invited to consider registering their organ donation decision by completing the registration form.
Enhanced video intervention: Classes allocated to the enhanced video intervention will follow the same procedure as the brief video intervention, but this intervention will screen an enhanced informative video about organ donation (10 minutes) which includes an interview with an organ donation recipient and a relative, in addition to the "Discover, Decide, Discuss" message.

One month after completion of the baseline survey (and intervention delivery where applicable), the research team will return to all classes involved to administer a brief follow-up questionnaire investigating changes in knowledge and attitudes as well as self-reported registration status.
Intervention code [1] 289640 0
Behaviour
Comparator / control treatment
Control: Classes allocated to the control condition will be invited to complete a baseline survey during class time only and will receive no active intervention. They will also be invited to complete the follow-up survey.
Control group
Active

Outcomes
Primary outcome [1] 292433 0
Proportion of students registered on the Australian Organ Donor Register measured by self-report and validated via the number of registration forms returned
Timepoint [1] 292433 0
Baseline and one month follow-up
Secondary outcome [1] 308936 0
Proportion of students reporting family conversations about organ donation measured by a questionnaire specifically developed by the research team
Timepoint [1] 308936 0
Baseline and one month follow-up
Secondary outcome [2] 309085 0
Organ donation knowledge measured by a questionnaire specifically developed by the research team
Timepoint [2] 309085 0
Baseline and one month follow-up
Secondary outcome [3] 309086 0
Organ donation attitudes measured by a questionnaire specifically developed by the research team
Timepoint [3] 309086 0
Baseline and one month follow-up

Eligibility
Key inclusion criteria
Aged 16 years or older, enrolled in a participating TAFE class, present in class on day of baseline survey delivery, can read and understand English
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 16 years of age, not enrolled in a participating TAFE class

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Class recruitment will be carried out by a TAFE representative who will approach class teachers, and ask permission for inclusion of their class in the study.
All eligible students in class on the day of the baseline survey will be invited to complete the survey. Return of a completed survey will be taken as implied consent.
Classes will be randomly allocated into one of three conditions via a computer random number generator and will be done by an independent statistician off-site to ensure adequate allocation concealment procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation into conditions: Classes will be stratified by faculty, course (where possible) and number of enrolled students. Classes will be block randomised. Randomisation will occur using a computer random number generator and will be completed by an independent statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Classes participating from the same faculty on the same day will be randomised to the same condition to reduce the likelihood of contamination.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming the baseline prevalence of students on organ donor registration is 12%, and that there are between 10 and 25 students available per class, with 30 classes recruited per arm the study will have 80% power to detect a difference of between 9-10% in the proportion of students on the organ donor registry at follow-up between any two arms of the study with 2.5% significance. This effect was calculated for intraclass correlations between 0.01 and 0.03.

Statistical Methods: Baseline characteristics of the intervention and control groups will be compared using proportions for categorical variables and means/standard deviations for continuous variables. Since the intervention is targeted at increasing individual donor rates the unit of analysis will be the individual. Primary outcome: Differences between the proportion that students who have signed up on the Australian Organ Donor Register at follow-up between either treatment arm and control will be assessed using a mixed effects logistic regression model. The model will include fixed effects for treatment (control, Intervention 1 or Intervention 2) and the cluster specific mean baseline proportion that are already registered. A random effect term for each class will be included to account for the clustering of students from the same class. The control arm will be used as the reference group and the p-value associated with either intervention arm will be used to determine the statistical significance. Either intervention will be considered statistically significantly better than the control if the p-value is less than 0.025. The primary analysis will be a complete case analysis, with sensitivity analysis undertaken to include all participants under an appropriate model for missing data. Agreement between self-reported registration and assessment of completed registration forms will be reported with the kappa statistic.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2014
Actual
4/08/2014
Date of last participant enrolment
Anticipated
24/11/2014
Actual
30/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
1080
Accrual to date
Final
1228
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8321 0
2297 - Tighes Hill

Funding & Sponsors
Funding source category [1] 289452 0
Government body
Name [1] 289452 0
National Health and Medical Research Council
Country [1] 289452 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 288140 0
None
Name [1] 288140 0
Address [1] 288140 0
Country [1] 288140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291210 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 291210 0
Ethics committee country [1] 291210 0
Australia
Date submitted for ethics approval [1] 291210 0
Approval date [1] 291210 0
15/06/2012
Ethics approval number [1] 291210 0
H-2012-0140

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49362 0
Prof Rob Sanson-Fisher
Address 49362 0
School of Medicine and Public Health, Faculty of Health
University of Newcastle
Level 4, West Wing
HMRI Building
University Drive, Callaghan
NSW 2308
Country 49362 0
Australia
Phone 49362 0
+61 2 40420713
Fax 49362 0
Email 49362 0
[email protected]
Contact person for public queries
Name 49363 0
Rob Sanson-Fisher
Address 49363 0
School of Medicine and Public Health, Faculty of Health
University of Newcastle
Level 4, West Wing
HMRI Building
University Drive, Callaghan
NSW 2308
Country 49363 0
Australia
Phone 49363 0
+61 2 40420713
Fax 49363 0
Email 49363 0
[email protected]
Contact person for scientific queries
Name 49364 0
Rob Sanson-Fisher
Address 49364 0
School of Medicine and Public Health, Faculty of Health
University of Newcastle
Level 4, West Wing
HMRI Building
University Drive, Callaghan
NSW 2308
Country 49364 0
Australia
Phone 49364 0
+61 2 40420713
Fax 49364 0
Email 49364 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.