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Trial registered on ANZCTR


Registration number
ACTRN12616000180415
Ethics application status
Approved
Date submitted
23/01/2016
Date registered
11/02/2016
Date last updated
11/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of an education package for increasing glaucoma knowledge and reducing anxiety in newly diagnosed glaucoma patients.
Scientific title
Efficacy of an education package for increasing glaucoma knowledge and reducing anxiety in newly diagnosed glaucoma patients.
Secondary ID [1] 288403 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 297410 0
Condition category
Condition code
Eye 297596 297596 0 0
Diseases / disorders of the eye
Public Health 297665 297665 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Education to newly diagnosed patients with glaucoma about the nature of the condition, treatment and daily management of treatment regimens.

Education is administered on individualised one-to-one sessions over the telephone via trained health professionals. This is a one off telephone session lasting 30 minutes. This telephone session is followed up 2-3 days later by a mail-out package of information booklets regarding the nature of glaucoma and some common issues regarding its treatment. The overall duration of the intervention period is 4 weeks, during which the telephone session and the mail-out occurs in the first 1-2 weeks. Completion of the telephone interview and mail out is recorded by study staff to ensure adherence to the intervention for all cases in the intervention arm of the study.
Intervention code [1] 293710 0
Lifestyle
Intervention code [2] 293711 0
Behaviour
Comparator / control treatment
The control group do not receive this education during the study, however receive the education once the study period is complete (4-5 weeks)
Control group
Active

Outcomes
Primary outcome [1] 297140 0
Change in score achieved on Glaucoma Knowledge Questionnaire (difference between baseline and final questionnaires, the latter administered 4 weeks following completion of baseline questionnaires)
Timepoint [1] 297140 0
At baseline and 4 weeks post baseline.
Secondary outcome [1] 320148 0
Change in score achieved on the Hospital Anxiety and Depression Score (difference between baseline and final questionnaires, the latter administered 4 weeks following completion of baseline questionnaires)
Timepoint [1] 320148 0
At baseline and 4 weeks post baseline.
Secondary outcome [2] 320330 0
Change in score achieved on the Eye Drop and Treatment Satisfaction Questionnaire
Timepoint [2] 320330 0
At baseline and 4 weeks post baseline.

Eligibility
Key inclusion criteria
Can read, speak and comprehend English or have the service of a valid interpreter
New diagnosis of open angle glaucoma
Glaucoma is treated with topical intraocular pressure-lowering drops
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent ocular surgery (in the past 2 months)

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)
The allocation of the randomised sequence will be recorded onto individual sheets of paper sealed in an opaque envelope; this will be the only record of the sequence. The envelopes will be opened by the study investigators individually and sequentially following enrolment of the study, and prior to data collection, and will be used to sequentially assign participants to the study groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will occur using a randomly generated sequence allocating participants on a 1:1 ratio. This sequence and the randomisation process will be concealed from the investigators enrolling participants. A computerised process will be used to generate a random sequence of numbers that fall into 2 categories; these will be respectively assigned to the control and treatment arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Power calculations were performed as follows. A significance level (alpha) of 5% and a power (1- beta) of 80% were chosen for two-tailed, non-paired student t test to compare final results in the glaucoma knowledge questionnaire. Predicted mean scores and standard deviation for the two groups were based on previous data.

Based on previous data the effect of education administration can be estimated to raise the score on the Glaucoma Knowledge Questionnaire by 9-12%.

Recruitment
Recruitment status
Recruiting
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] 292754 0
Charities/Societies/Foundations
Name [1] 292754 0
Carr Family Trust
Address [1] 292754 0
37 Framont Avenue
HOLLAND PARK QLD 4121
Country [1] 292754 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 291485 0
None
Name [1] 291485 0
none
Address [1] 291485 0
none
Country [1] 291485 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294240 0
Royal Australian and New Zealand College of Ophthalmology Human Research Ethics Committee
Ethics committee address [1] 294240 0
94-98 Chalmers St, Surry Hills NSW 2010
Ethics committee country [1] 294240 0
Australia
Date submitted for ethics approval [1] 294240 0
05/08/2014
Approval date [1] 294240 0
28/10/2014
Ethics approval number [1] 294240 0
48.14

Summary
Brief summary
We aim to investigate the impact of a telephone-based education schemes for newly diagnosed patients with glaucoma. Newly diagnosed glaucoma patients treated with drops are randomised to either the control or treatment arm. All have questionnaires administered over the telephone at the study outset and at completion, 4 weeks following the outset. The questionnaires include a Glaucoma-knowledge Questionnaire, an anxiety scale and an Eye Drop Satisfaction Questionnaire.

Patients in the intervention arm will receive the education in the first week of the study period. THose in the control arm will only receive that information once the study is completed. We will measure differences in changes of scores from outset to conclusion of the study looking for differences between the intervention and control groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63006 0
Dr Simon Skalicky
Address 63006 0
Melbourne Eye Care
338 Balaclava Rd Caulfield North VIC 3161
Country 63006 0
Australia
Phone 63006 0
+61 3 9509 9293
Fax 63006 0
+61 3 9509 9911
Email 63006 0
sskalicky@eyesurgery.com.au
Contact person for public queries
Name 63007 0
Dr Simon Skalicky
Address 63007 0
Melbourne Eye Care
338 Balaclava Rd Caulfield North VIC 3161
Country 63007 0
Australia
Phone 63007 0
+61 3 9509 9293
Fax 63007 0
+61 3 9509 9911
Email 63007 0
sskalicky@eyesurgery.com.au
Contact person for scientific queries
Name 63008 0
Dr Simon Skalicky
Address 63008 0
Melbourne Eye Care
338 Balaclava Rd Caulfield North VIC 3161
Country 63008 0
Australia
Phone 63008 0
+61 3 9509 9293
Fax 63008 0
+61 3 9509 9911
Email 63008 0
sskalicky@eyesurgery.com.au

No information has been provided regarding IPD availability
Summary results
No Results