ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Glaucoma

Condition category

Condition code

Eye

Diseases / disorders of the eye

Public Health

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]

Lifestyle

Intervention code [2]

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]

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]

At baseline and 4 weeks post baseline.

Secondary outcome [1]

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]

At baseline and 4 weeks post baseline.

Secondary outcome [2]

Change in score achieved on the Eye Drop and Treatment Satisfaction Questionnaire

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/04/2015

Date of last participant enrolment

Anticipated

1/07/2016

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Carr Family Trust

Address [1]

37 Framont Avenue
HOLLAND PARK QLD 4121

Country [1]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

Parkville VIC 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Australian and New Zealand College of Ophthalmology Human Research Ethics Committee

Ethics committee address [1]

94-98 Chalmers St, Surry Hills NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/08/2014

Approval date [1]

28/10/2014

Ethics approval number [1]

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

Dr Simon Skalicky

Address

Melbourne Eye Care
338 Balaclava Rd Caulfield North VIC 3161

Country

Australia

Phone

+61 3 9509 9293

Fax

+61 3 9509 9911

[email protected]

Contact person for public queries

Name

Simon Skalicky

Address

Melbourne Eye Care
338 Balaclava Rd Caulfield North VIC 3161

Country

Australia

Phone

+61 3 9509 9293

Fax

+61 3 9509 9911

[email protected]

Contact person for scientific queries

Name

Simon Skalicky

Address

Melbourne Eye Care
338 Balaclava Rd Caulfield North VIC 3161

Country

Australia

Phone

+61 3 9509 9293

Fax

+61 3 9509 9911

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		7. Skalicky SE, D’Mellow G, House P, et al. The Gl... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Glaucoma Australia educational impact study: a randomized short-term clinical trial evaluating the association between glaucoma education and patient knowledge, anxiety and treatment satisfaction.	2018	https://dx.doi.org/10.1111/ceo.13016

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically