Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001204235
Ethics application status
Approved
Date submitted
28/06/2018
Date registered
18/07/2018
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A model of culturally-informed integration of diabetic retinopathy screening and diabetes education assessment in Indigenous primary care settings.
Scientific title
A model of integration of diabetic retinopathy screening (DRS) into a diabetes education (DE) service to improve patient engagement with diabetes self-management and to increase diabetic retinopathy screening rates among Indigenous Australians.
Secondary ID [1] 295276 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic retinopathy 308530 0
Type 2 Diabetes Mellitus 308531 0
Condition category
Condition code
Eye 307499 307499 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 307500 307500 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diabetic retinopathy Screening
a) any physical or informational materials used,
Consenting participants will be given a copy of the ethics approved plain language statement. Participants will also be shown digital images of their eyes to discuss retinopathy and facilitate education about related complications of diabetes. To further assist with diabetes education, educational tools such as Feltman (life-size wall hanging) and HbA1c risk-gradient card will be used.
b) each of the procedures, activities, and/or processes used,
The following procedures and activities will be undertaken at baseline and final visits:
1) Measuring and recording of presenting vision and, if this is < 6/12, pinhole vision as well.
2) Diabetic retinopathy imaging will be undertaken. Protocol will consist of 3 images per eye. [disc-centred, macular-centred and an exterior eye image]. Captured images will be sent to an external ophthalmic clinician or certified grader for retinopathy grading and follow-up recommendations based on NHMRC guidelines for management of diabetic retinopathy (2008).
3) Diabetes education will be provided based on standard diabetes education, retinal fundus images and Indigenous pedagogy
4) Ethics approved surveys will be administered. These are Diabetes Knowledge, SNAPE (smoking, nutrition, alcohol, physical activity & emotional wellbeing) and Vision Impairment surveys. At the final visit, a diabetes care satisfaction survey will also be administered.
c) who will deliver the intervention,
Intervention will be delivered by an Indigenous credentialled diabetes educator and registered nurse who is also an experienced and certified retinal imager.
d) the mode of delivery,
Mode of delivery will be by face-to-face individual consultation
e) the number of times the intervention will be delivered and over what period of time,
The intervention will be delivered twice, the first time being the baseline visit and the second being 12 months later, or sooner based on initial grading report recommendations for followup.
f) the location where the intervention occurs.
Intervention will occur at partner Aboriginal Community-Controlled Health Service primary care clinics in regional Victoria, the first being Rumbalara Aboriginal Cooperative – Health Service

Intervention code [1] 301656 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306471 0
Percentage returning for recommended eye screening as per initial grading report recommendations [based on NHMRC guidelines for the management of diabetic retinopathy (2008)]. For example, in the subset without retinopathy, the % returning for diabetic retinopathy screening within 12 months of baseline eye screening.
Eye screening data will be collected from the laptop specific program that automatically captures and stores the retinal images. Each set of images are identified patient identification number, name, age and sex. Data specifically relating to patient adherence to NHMRC eye screening recommendations (when they last seen the optometrist) will be extracted from their electronic health records (Commuicare) and for verification, patient will be asked when/and if they have had a comprehensive eye exam in the last 12 months
Timepoint [1] 306471 0
1) Baseline visit - 2018
2) Final visit - 2019
Secondary outcome [1] 348633 0
1) Diabetes knowledge score
The score will be taken from the validated Diabetes Knowledge Questionnaire (Eigenmann,Skinner & Colagiuri 2011)
Timepoint [1] 348633 0
1) Baseline health service DRS uptake - 2018
2) Final health service DRS uptake - 2019
Secondary outcome [2] 349420 0
2) SNAPE survey scores. Will be gathered from the adapted TEAMSNET SNAPE (smoking, nutrition, alcohol, physical-activity, emotional well-being) survey (Brazionis 2015)
- Smoking status
- Diet quality
- Alcohol consumption
- Physical activity level
- Adapted PHQ9

An adverse event potential exists where an individual records a high score on the adapted PHQ9 survey. If a participant’s score is great than 20 on the adapted PHQ9 survey, the participant will be accompanied by the research nurse to a doctor for emergency mental health assessment and management.
Timepoint [2] 349420 0
November 2019
Secondary outcome [3] 349421 0
3) Vision level
Vision level will be determined from finding collated from the validated vision impairment survey (CERA 2008)
Timepoint [3] 349421 0
November 2019

Eligibility
Key inclusion criteria
Patients of primary health services that have been diagnosed with Type 2 Diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients of primary health services who have not been diagnosed with Type 2 Diabetes

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The researchers will conduct data analyses using Excel and SPSS software. Analyses using descriptive statistics and uni-variate analyses (test for continuous and Chi-squared for categorical variables) will provide key descriptive data, such as prevalence rates and lifestyle data, proportion treated to target for DR risk factors and predictors of DR, vision outcomes and qualitative survey data.
Site differences will be analysed. Analysis of covariance (ANCOVA) will be used to compare differences between groups. To assess confounding, covariates will include age, gender, and established and emerging risk factors for diabetes and DR, as appropriate. Non-parametric statistics will be used when assumptions for parametric methods are violated. All tests will be conducted using an alpha level of
0.05 and 95% confidence intervals or interquartile ranges, as appropriate, will be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/06/2018
Date of last participant enrolment
Anticipated
30/11/2018
Actual
Date of last data collection
Anticipated
30/11/2019
Actual
Sample size
Target
250
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 23116 0
3629 - Mooroopna
Recruitment postcode(s) [2] 23117 0
3550 - Bendigo
Recruitment postcode(s) [3] 23118 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 299867 0
University
Name [1] 299867 0
The University of Melbourne-Research Training Program Scholarship
Country [1] 299867 0
Australia
Funding source category [2] 300102 0
University
Name [2] 300102 0
University of Sydney - NHMRC CRE in Diabetic Retinopathy
Country [2] 300102 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Department of Medicine
The University of Melbourne
St Vincent's Hospital
Level 4 Clinical Sciences Building
29 Regent Street (corner of Princes and Regent Streets)
Fitzroy, Melbourne, VIC 3065
Australia
Country
Australia
Secondary sponsor category [1] 299306 0
Individual
Name [1] 299306 0
Sharon Atkinson-Briggs
Address [1] 299306 0
Department of Medicine
The University of Melbourne
[St Vincent's Hospital]
Level 4 Clinical Sciences Building
29 Regent Street (corner of Princes and Regent Streets)
Fitzroy, Melbourne, VIC 3065
Country [1] 299306 0
Australia
Other collaborator category [1] 280209 0
University
Name [1] 280209 0
University of Sydney
Address [1] 280209 0
Centre for Research Excellence in Diabetic Retinopathy
NHMRC Clinical Trials Centre
University of Sydney
92-94 Parramatta Road
Camperdown
Sydney
NSW 2050
Country [1] 280209 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300738 0
University of Melbourne Human Central Human Research Ethics Committee
Ethics committee address [1] 300738 0
Research Ethics & Integrity
Level 4, 161 Barry Street
The University of Melbourne
Victoria 3010
Ethics committee country [1] 300738 0
Australia
Date submitted for ethics approval [1] 300738 0
24/02/2018
Approval date [1] 300738 0
30/05/2018
Ethics approval number [1] 300738 0
1750594

Summary
Brief summary
Diabetic retinopathy is a major public health problem in Australia, particularly among Indigenous Australians. For this reason, national guidelines in Australia were first developed for diabetic retinopathy. Despite efforts over two decades aimed at timely detection and early treatment of diabetic retinopathy, about half the Indigenous population with diabetes in Australia is not screened in accordance with the guidelines. Novel approaches to screening for diabetic retinopathy are needed, particularly in Australia's remote, under-resourced and Indigenous communities.The aim of this project is to implement an imaging-based telehealth diabetic retinopathy screening program managed by a diabetes educator in Indigenous primary care clinics.

Objectives
1) To develop a model of integrated DE and DRS assessment in regional Indigenous primary care services.

2) To develop culturally-informed DE and DRS programs with input from Indigenous stakeholders.
3) To improve DRS coverage in Indigenous primary health care services.

4) Use DRS images and vision status to reinforce importance of diabetes self-management for reducing risk of all diabetes complications.

5) Facilitate timely referral pathways to ophthalmic services and diabetes specialist services.
Research Design
Proof of concept trial using a qualitative and quantitative approach.

Up to three rural/regional trial-sites and approximately 250 T2DM participants aged older than 18 years of age
Pre-post trial design: diabetic retinopathy screening, assessing health literacy, clinical and lifestyle risk factors, social/emotional well-being, satisfaction with diabetes education, perceived barriers/motivators to access and follow-up services.
Baseline visit:
Diabetic retinopathy screening, Smoking, Nutrition, Alcohol, Physical (activity) and Emotional (well-being) [SNAPE] and Vision Impairment Questionnaires to will be administered. HbA1c, lipids and blood pressure will also be measured to gauge patient’s baseline diabetes self-management. Surveys will assess a patient’s diabetes knowledge and health literacy,
Final visit:
Diabetic retinopathy screening repeated to assess adherence to annual screening recommendation, administration of the Diabetes Knowledge Questionnaire to gauge if patient’s diabetes knowledge has increased and self-care has improved over the intervention period, repeat measurement of patient’s HbA1c, lipids and blood pressure to see if diabetes risk factor control has improved. Patients will also have administered the Diabetes Treatment Satisfaction Questionnaire that will gauge patient’s satisfaction with the intervention over time. With integration of diabetes education and diabetic retinopathy screening, it is expected that engagement with self-management [risk factor control and adherence to retinopathy screening recommendations] will improve.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84650 0
Dr Laima Brazionis
Address 84650 0
Department of Medicine
The University of Melbourne
[St Vincent's Hospital]
Level 4 Clinical Sciences Building
29 Regent Street (Corner of Princess and Regent Streets)
Fitzroy, Melbourne Victoria 3065
Country 84650 0
Australia
Phone 84650 0
+61 (0)417160043
Fax 84650 0
Email 84650 0
[email protected]
Contact person for public queries
Name 84651 0
Dr Laima Brazionis
Address 84651 0
Department of Medicine
The University of Melbourne
[St Vincent's Hospital]
Level 4 Clinical Sciences Building
29 Regent Street (Corner of Princess and Regent Streets)
Fitzroy, Melbourne Victoria 3065
Country 84651 0
Australia
Phone 84651 0
+61 (0)417160043
Fax 84651 0
Email 84651 0
[email protected]
Contact person for scientific queries
Name 84652 0
Dr Laima Brazionis
Address 84652 0
Department of Medicine
The University of Melbourne
[St Vincent's Hospital]
Level 4 Clinical Sciences Building
29 Regent Street (Corner of Princess and Regent Streets)
Fitzroy, Melbourne Victoria 3065
Country 84652 0
Australia
Phone 84652 0
+61 (0)417160043
Fax 84652 0
Email 84652 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

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