Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000248460
Ethics application status
Approved
Date submitted
4/05/2007
Date registered
8/05/2007
Date last updated
13/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comprehension of medicine label instructions - a pilot study in glaucoma patients.
Scientific title
Are large print labels, on eye medications, required by glaucoma patient's to assist their comprehension of prescribed treatment?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma, medication recall, comprehension of medication instructions, compliance to treatment, visual function, severity of disease. 1787 0
Condition category
Condition code
Eye 1873 1873 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Written informed consent will be obtained from all paricipants.
Participants will have their near vision assessed with their usual correction / glasses.
Thirdly, they will be asked to recall their own eye medication use; name, dose and instructions for use for each.
Finally, they will be asked 3 repeat questions on 4 sample eye drop labels. The questions are structured to allow identification of "the name of the medicine", "which eye the medicine is for" and "how often the medicine should be used". Answers will be recorded as either correct or incorrect.
Participants will be presented 2 standard and 2 large print labels in a set format and permitted a few minutes to examine each before being questioned.
Assessment time approximately 5-10 minutes.
Intervention code [1] 1743 0
Behaviour
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2661 0
Correlation between level of visual function and simultaneous ability to correctly identify information on standard print labels.
Timepoint [1] 2661 0
Assessed through a standard questionaire that follows the presentation of each the sample print labels.
Secondary outcome [1] 4517 0
Correlation between level of visual function and simultaneous ability to recall own eye medication name/s and instructions for use.
Timepoint [1] 4517 0
This is assessed through a standard questionaire that precedes label intervention / presentation.
Secondary outcome [2] 4518 0
Identify ocular disease characteristics of patients who are detected as unable to currently read information on standard print labels.
Timepoint [2] 4518 0
This information is obtained through medical history review once the participant has seen the doctor for his/her appointment at the Hospital. Set data collection form used.

Eligibility
Key inclusion criteria
Patients on any number of medication eye drops who have not had their eyes dilated in the pre-assessment clinic.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that do not speak English.

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



Intervention assignment
Single group
Other design features
Endpoint - clinical evidence to support recommended large print label on eye medication dispensed at Hospital pharmacy.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 592 0
3002

Funding & Sponsors
Funding source category [1] 2020 0
Hospital
Name [1] 2020 0
Royal Victorian Eye and Ear Hospital
Country [1] 2020 0
Australia
Funding source category [2] 3127 0
Self funded/Unfunded
Name [2] 3127 0
Royal Victorian Eye and Ear Hospital
Country [2] 3127 0
Australia
Funding source category [3] 3128 0
Self funded/Unfunded
Name [3] 3128 0
Centre for Eye Research Australia
Country [3] 3128 0
Australia
Primary sponsor type
Individual
Name
Catherine Rokhahr, Pharmacy, Royal Victorian Eye and Ear Hospital.
Address
Phramacy Dept, Gnd, 32 Gisborne Street, East melbourne, VIC, 3002
Country
Australia
Secondary sponsor category [1] 1830 0
Individual
Name [1] 1830 0
Professor Jonathan Crowston
Address [1] 1830 0
Glaucoma Investigation and Research Unit
Centre for Eye Research Australia
Country [1] 1830 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3747 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 3747 0
32 Gisborne Street, East melbourne, VIC, 3002
Ethics committee country [1] 3747 0
Australia
Date submitted for ethics approval [1] 3747 0
Approval date [1] 3747 0
16/10/2006
Ethics approval number [1] 3747 0
06/707H

Summary
Brief summary
Main purpose of this study is to identify if there is a need to offer of a large print label, on eye medications, to glaucoma patients that display certain visual function and disease characteristics. In turn, this may assist these patients in adhering to their prescribed treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27846 0
Address 27846 0
Country 27846 0
Phone 27846 0
Fax 27846 0
Email 27846 0
Contact person for public queries
Name 10932 0
Ms Catherine Rokahr
Address 10932 0
Pharmacy
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne VIC 3002
Country 10932 0
Australia
Phone 10932 0
03 9929 8205
Fax 10932 0
03 9929 8208
Email 10932 0
[email protected]
Contact person for scientific queries
Name 1860 0
Ms Fleur O'Hare
Address 1860 0
Centre for Eye Research Australia
Glaucoma Investigation and Research Unit
Level 1
32 Gisborne Street
East Melbourne VIC 3002
Country 1860 0
Australia
Phone 1860 0
03 9929 8791
Fax 1860 0
03 9929 8164
Email 1860 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.