Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000984796
Ethics application status
Approved
Date submitted
4/05/2022
Date registered
13/07/2022
Date last updated
13/07/2022
Date data sharing statement initially provided
13/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
An educational intervention to understand Attitudes and address Barriers to Care in Age-related Macular Degeneration: A randomised controlled trial
Scientific title
An educational intervention to understand Attitudes and address Barriers to Care in Age-related Macular Degeneration: A randomised controlled trial
Secondary ID [1] 307056 0
CRTH258AAU02T
Universal Trial Number (UTN)
U1111-1277-9291
Trial acronym
The ABCs of AMD
Linked study record
None.

Health condition
Health condition(s) or problem(s) studied:
Age-related macular degeneration 326202 0
Condition category
Condition code
Eye 323506 323506 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient-determined education has content designed by patients and clinicians:
Attending clinician will deliver Patient-determined Education package during routine baseline clinical eye exam:
- Will involve 5 to 10 minutes of face-to-face education on stage of disease diagnosed at this visit plus relevant treatments appropriate to stage (Ex. smoking cessation, use of Amsler Grid, use of eye health supplements or eye injections). Conversations guided primarily by patient questions and interest.
- May involve material to take-home to read. Material (one page brochure) depends on stage of disease diagnosed at this visit plus relevant treatments appropriate to stage (Ex. smoking cessation, use of Amsler Grid, use of eye health supplements or eye injections) based on most recent published evidence. Take home material offered determined by patient interest and questions.
- May be supported by follow-up text message reminders monthly for 6 months post-enrolment. Reminders will focus on treatments relevant to stage of disease diagnosed and may address smoking cessation, use of Amsler Grid, use of eye health supplements or eye injections. Text reminders enrolled determined by patient questions and interests.
Intervention code [1] 323506 0
Other interventions
Comparator / control treatment
Clinician-determined education has content designed by clinicians (Pragmatic Standard Care, may vary from clinician to clinician):
Attending clinician will deliver Clinician-determined Education package during routine baseline clinical eye exam:
- Will involve 5 to 10 minutes of face-to-face education on stage of disease diagnosed at this visit plus relevant treatments appropriate to stage (Ex. weight loss, exercise, healthy eating, smoking cessation, use of Amsler Grid, use of eye health supplements or eye injections). Conversations guided primarily by clinician determination of patient's need as per clinician's standard practice.
- May involve material to take-home to read. Material (one page brochure) depends on stage of disease diagnosed at this visit plus relevant treatments appropriate to stage (Ex. weight loss, exercise, healthy eating, smoking cessation, use of Amsler Grid, use of eye health supplements or eye injections) . Content of take home material and whether it is offered to patient is determined by clinician as per their standard practice.
- May be supported by follow-up text message reminders monthly for 6 months post-enrolment. Reminders will focus on treatments relevant to stage of disease diagnosed and may address weight loss, exercise, healthy eating, smoking cessation, use of Amsler Grid, use of eye health supplements or eye injections. Text reminders that patient is enrolled to receive is determined by clinician as per their standard practice.
Control group
Active

Outcomes
Primary outcome [1] 331257 0
Composite measure of attitudes towards appropriate care for AMD will be assessed with study-specific questionnaires:
- attitude towards smoking cessation;
- attitude towards antioxidant supplementation;
- attitude towards use of the Amsler Grid to monitor progression and;
- attitude toward anti-VEGF treatment.
Timepoint [1] 331257 0
6 months post-enrolment.
Secondary outcome [1] 409332 0
Attitudes towards smoking cessation assessed with study-specific questionnaire.
Timepoint [1] 409332 0
6 months post enrolment.
Secondary outcome [2] 409509 0
Attitudes towards antioxidant supplementation assessed with study-specific questionnaire..
Timepoint [2] 409509 0
6 months post enrolment
Secondary outcome [3] 409510 0
Attitudes towards use of the Amsler Grid to monitor progression assessed with study-specific questionnaire.
Timepoint [3] 409510 0
6 months post enrolment
Secondary outcome [4] 409511 0
Attitudes towards anti-VEGF treatment assessed with study-specific questionnaire.
Timepoint [4] 409511 0
6 months post enrolment
Secondary outcome [5] 409512 0
Changes in health literacy assessed with study-specific health literacy questionnaire.
Timepoint [5] 409512 0
6 months post enrolment
Secondary outcome [6] 409514 0
Participation in AMD-related support programmes assessed with study-specific questionnaire.
Timepoint [6] 409514 0
6 months post enrolment
Secondary outcome [7] 409515 0
frequency of follow-up care assessed with study-specific questionnaire.
Timepoint [7] 409515 0
6 months post enrolment
Secondary outcome [8] 409516 0
other (new) ocular pathologies assessed with study-specific questionnaire.
Timepoint [8] 409516 0
6 months post enrolment
Secondary outcome [9] 409517 0
estimates of costs to participants and society assessed by stochastic simulation based on reported results of assessed with study-specific questionnaire..
Timepoint [9] 409517 0
6 months post enrolment

Eligibility
Key inclusion criteria
Adults (age greater than 50) diagnosed at the Centre for Eye Health between with:
• Large drusen at the macula in either eye,
• Pigmentary abnormalities associated with at least medium sized drusen in either eye,
• Late AMD (geographic atrophy)
• Late AMD (macular neovascularization)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants must be able to communicate effectively in English and be legally capable to provide formal written direct consent to participate.
Potential participants intending to move outside of the study catchment area (NSW) over the duration of study conduct will not be eligible.
Patients with other co-morbid ocular disease (Ex. glaucoma) requiring treatment will also not be eligible to participate.

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)
Sealed opaque sequentially numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random shuffle, as appropriate per sealed opaque sequentially numbered envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ITT, as per ICH GCP guideline E9: Statistical Principles for Clinical Trials.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/05/2022
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
130
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22313 0
Centre for Eye Health - Kensington
Recruitment postcode(s) [1] 37474 0
2052 - Kensington

Funding & Sponsors
Funding source category [1] 311361 0
Commercial sector/Industry
Name [1] 311361 0
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED
Country [1] 311361 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales,
Kensington, NSW 2052
Country
Australia
Secondary sponsor category [1] 312753 0
None
Name [1] 312753 0
Address [1] 312753 0
Country [1] 312753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310854 0
Human Research Ethics Committee - UNSW
Ethics committee address [1] 310854 0
Ethics committee country [1] 310854 0
Australia
Date submitted for ethics approval [1] 310854 0
Approval date [1] 310854 0
15/10/2021
Ethics approval number [1] 310854 0
HC210745

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

Contacts
Principal investigator
Name 119102 0
Dr Angelica Ly
Address 119102 0
UNSW,
Rupert Myers Building (south wing)
Gate 14, Barker St,
Sydney NSW 2052
Country 119102 0
Australia
Phone 119102 0
+61281150746
Fax 119102 0
Email 119102 0
a.ly@unsw.edu.au
Contact person for public queries
Name 119103 0
Angelica Ly
Address 119103 0
UNSW,
Rupert Myers Building (south wing)
Gate 14, Barker St,
Sydney NSW 2052
Country 119103 0
Australia
Phone 119103 0
+61281150746
Fax 119103 0
Email 119103 0
a.ly@unsw.edu.au
Contact person for scientific queries
Name 119104 0
Angelica Ly
Address 119104 0
UNSW,
Rupert Myers Building (south wing)
Gate 14, Barker St,
Sydney NSW 2052
Country 119104 0
Australia
Phone 119104 0
+61281150746
Fax 119104 0
Email 119104 0
a.ly@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Unable to address this issue at this time.


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.