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Trial registered on ANZCTR


Registration number
ACTRN12614001110673
Ethics application status
Approved
Date submitted
3/10/2014
Date registered
20/10/2014
Date last updated
12/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Diabetes and Eye Health project: increasing eye examinations for adults newly diagnosed with type 2 diabetes.
Scientific title
Development and evaluation of a psycho-educational leaflet to increase the rate of eye examinations for adults newly diagnosed with type 2 diabetes from the following two groups:
1. early onset type 2 diabetes (aged 18-39 years), or
2. who live in rural and regional Victoria
Secondary ID [1] 285373 0
Nil
Universal Trial Number (UTN)
U1111-1161-9803
Trial acronym
yourSAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes
293104 0
Diabetic retinopathy 293105 0
Condition category
Condition code
Public Health 293378 293378 0 0
Health promotion/education
Metabolic and Endocrine 293558 293558 0 0
Diabetes
Eye 293559 293559 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: printed materials (leaflet) containing persuasive behaviour change messages designed to raise awareness of the importance of maintaining optimal blood glucose and blood pressure levels to minimise the risk of diabetic retinopathy, increase intentions to engage in regular eye examinations and increase self-reported eye examinations.
Delivery: the leaflet will be mailed on a single occasion to study participants.
Intervention code [1] 290355 0
Prevention
Intervention code [2] 290359 0
Behaviour
Comparator / control treatment
Control group participants given the opportunity to receive the leaflet at the end ofthe study.
Control group
Active

Outcomes
Primary outcome [1] 293286 0
Outcome is increase/decrease in self-reported eye health examinations assessed via response to a single questionnaire item ("Since you were diagnosed with diabetes, have you had your eye health checked?").

In order to minimise social desirability bias and any potential confounding influence of question-behaviour effect, the question will be embedded within a suite of standard self-management questions based on information already provided to all new NDSS registrants
Timepoint [1] 293286 0
Baseline and six months after randomisation
Secondary outcome [1] 310717 0
Outcome is increase/decrease in intention to seek eye health examinations assessed via summed response to three intention items designed specifically for this purpose.
Timepoint [1] 310717 0
Baseline and six months after randomisation
Secondary outcome [2] 310718 0
Outcome is increase/decrease in knowledge of modifiable risk factors associated with diabetic retinopathy assessed using a questionnaire designed specifically for this study.
Timepoint [2] 310718 0
Baseline and six months after randomisation

Eligibility
Key inclusion criteria
1. Diagnosed with type 2 diabetes in the past three years
2. Australian residents
3. Able to read English
4. Registered with the National Diabetes Services Scheme (NDSS)
5. One of either:
- young adult (aged 18-39 years), or
- live in rural/regional locations of Victoria, Australia
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other diabetes types (e.g. Type 1, gestational, MODY)
Impaired cognitive ability

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subject enrolment: all eligible NDSS registrants who have agreed to be contacted for research will receive an invitation to participate in the Diabetes and Eye Health (Phase 2) study. If interested, they can enter the study website (www.yoursay.org.au) where they will be asked to confirm eligibility status and will be asked to read the Plain Language Statement. At this point, they can consent to continue with the study. Participants will only be identified by their computer's IP address and will be randomly allocated using the method outlined below where treatment allocation is concealed from those administering the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized to one of two treatment arms (intervention vs no intervention). Group allocation will be managed by an independent third party using an online random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Other design feature (above) no longer applies. Explanation provided below (see 'updated statistical methods' and 'reason')
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Revised minimum sample size: a power analysis was conducted using G*Power, calculating required sample size for eye examination rate increase from 40%to 80%. Power and significance levels remained the same. It was estimated that a sample size of 50 (i.e. 25 in each group) study participants who had not previously had eye examinations since their diabetes diagnosis was sufficient to adequately power the study.

Statistical analyses: discriminant function analysis will be conducted to assess differences between conditions (ie. eye examinations) on demographic characteristics and baseline outcome measures. Binomial logistic regression analyses will be conducted on pre-intervention data to determine which modifiable cognitions are most strongly correlated with having had an eye exam. They will be rank ordered in terms of discriminant capacity and highest ranking messages retained for inclusion in psycho-educational leaflet.

All analyses will be performed on an intention-to-treat basis in the first instance although per protocol analyses may also be conducted to further explore the pattern of results. Effect sizes will be calculated and reported as odds ratios (OR) with 95% CI and missing covariate values will be imputed using multiple imputation (MI) methods.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290040 0
Government body
Name [1] 290040 0
Vision 2020 Australia
Address [1] 290040 0
2/174-176 Queen St, Melbourne VIC 3000
Country [1] 290040 0
Australia
Primary sponsor type
University
Name
Deakin University (The Australian Centre for Behavioural Research in Diabetes)
Address
The Australian Centre for Behavioural Reserch in Diabetes
c/- School of Psychology, Deakin University
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 288731 0
Charities/Societies/Foundations
Name [1] 288731 0
Diabetes - Australia (Victoria)
Address [1] 288731 0
570 Elizabeth Street
Melbourne
VIC 3000
Country [1] 288731 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291751 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 291751 0
Deakin Research Integrity
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Ethics committee country [1] 291751 0
Australia
Date submitted for ethics approval [1] 291751 0
26/06/2014
Approval date [1] 291751 0
28/07/2014
Ethics approval number [1] 291751 0
2014-156
Ethics committee name [2] 299607 0
Deakin University Human Research Ethics Committee
Ethics committee address [2] 299607 0
221 Burwood Highway,
Burwood VIC 3125
Ethics committee country [2] 299607 0
Australia
Date submitted for ethics approval [2] 299607 0
06/11/2014
Approval date [2] 299607 0
10/11/2014
Ethics approval number [2] 299607 0
2014-156

Summary
Brief summary
People with diabetes are vulnerable to diabetic retinopathy (DR); a common complication that damages the blood vessels at the back of the eye. The early stages of DR are asymptomatic; early detection via eye examination and timely treatment are important in reducing the risk of vision loss. National Health and Medical Research Council recommend eye examinations at diabetes diagnosis and minimum every two years thereafter. Some at-risk groups have unacceptably low eye examination rates, including adults with type 2 diabetes (T2DM) who are i) 18-39 years or ii) from rural/regional Victoria (eye exam rates are 50% and 65% respectively).

The aim of this project is to develop communication messages designed to increase eye examination rates for people from the two at-risk groups. Presented in leaflet format, the messages will be mailed to eligible registrants on the National Diabetes Services Scheme (NDSS). It is hypothesized that participants who have not previously had an eye examination and who receive a psycho-educational leaflet intervention containing theoretically derived messages demonstrated to correlate with the target behaviour will report:
a. Increased intentions to seek eye examinations, and
b. Higher rate of eye examinations than control group participants, at follow up.
Trial website
www.yoursay.org.au
Trial related presentations / publications
Public notes
Unfortunately, low recruitment numbers have necessitated a redesign of the RCT to a 2-group design only (Intervention and Control). Although the two group design will be able to assess effectiveness of the behaviour change leaflet (dependent upon adequate retention of participants throughout the study), it will not be able to control for question behaviour effect which was detected in Phase 1 of the Diabetes and Eye Health project.
The design revision received approval from Deakin University Human Research Ethics Committee on 10 November 2014.
Attachments [1] 206 206 0 0

Contacts
Principal investigator
Name 51566 0
Prof Jane Speight
Address 51566 0
The Australian Centre for Behavioural Reserch in Diabetes
c/- 570 Elizabeth Street
Melbourne VIC 3000
Country 51566 0
Australia
Phone 51566 0
+61 (0)3 9244 6448
Fax 51566 0
N/A
Email 51566 0
jspeight@acbrd.org.au
Contact person for public queries
Name 51567 0
Ms Amelia Lake
Address 51567 0
The Australian Centre for Behavioural Reserch in Diabetes
c/- 570 Elizabeth Street
Melbourne VIC 3000
Country 51567 0
Australia
Phone 51567 0
+61 3 9244 6448
Fax 51567 0
N/A
Email 51567 0
alake@acbrd.org.au
Contact person for scientific queries
Name 51568 0
Prof Jane Speight
Address 51568 0
The Australian Centre for Behavioural Reserch in Diabetes
c/- 570 Elizabeth Street
Melbourne VIC 3000
Country 51568 0
Australia
Phone 51568 0
+61 3 9244 6448
Fax 51568 0
N/A
Email 51568 0
jspeight@acbrd.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary