Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000587505
Ethics application status
Approved
Date submitted
15/05/2015
Date registered
4/06/2015
Date last updated
4/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Residential Ocular Care Study: A Multi-Centered, Randomized Controlled Clinical Trial comparing the effectiveness of an innovative and comprehensive new eye care model with usual care for individuals in Residential Aged Care Facilities
Scientific title
The Residential Ocular Care Study: A Multi-Centered, Randomized Controlled Clinical Trial comparing the effectiveness of an innovative and comprehensive new eye care model with usual care for individuals in Residential Aged Care Facilities
Secondary ID [1] 286707 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vision impairment 295064 0
Mobility 295066 0
Falls 295067 0
Depression 295068 0
Condition category
Condition code
Eye 295316 295316 0 0
Diseases / disorders of the eye
Mental Health 295404 295404 0 0
Depression
Injuries and Accidents 295405 295405 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the Residential Ocular Care (ROC) intervention model, which is a novel model of eye care for people living in residential care facilities. This
comprehensive model includes a thorough on-site eye examination with four subsequent intervention
options for those with vision impairment, namely:
(a) refraction and spectacle provision - glasses will be prescribed;
(b) cataract surgery - participants will be referred to the Royal Victorian Eye and Ear hospital as a public patient where surgery costs will be covered, or they can elect to go privately but will have to cover any out of pocket costs. Reimbursement will be covered for travel to and from the surgery as well as for preop assessments and 2 post op assessments;
(c) low vision rehabilitation - participants will be referred to Vision Australia where low vision therapists will conduct a low vision examination and dispense low vision aids. A follow up session and training session on how to use the aids will also be provided; and
(d) referral to an ophthalmologist for medical and surgical treatments for conditions likely to cause loss of sight or ocular discomfort. If our vision assessment uncovers cases of vision impairment not covered by the other interventions a referral will be made to an appropriate ophthalmologist at a local public hospital for medical treatment or surgical interventions as required at no cost to the participant.

Participants will only be given one of the 4 interventions specified above that best suits their need.

The ROC Model of care will be administered at Baseline visits where one of the four interventions will be given.

Quality of life questionnaires will be administered at baseline, 2 month and 6 month.

At 6 month optometrists will conduct another comprehensive eye tests

The onsite comprehensive eye examinations are carried out by the Optometrist from the Australian College of Optometry and involve testing of visual acuity, subjective refraction and reading fluency. Examinations will be carried out to assess intraocular eye pressures, visual fields and dilated examinations of the back of the eye. Scans will also be taken of the back of the eye.
Intervention code [1] 291857 0
Rehabilitation
Intervention code [2] 291859 0
Diagnosis / Prognosis
Intervention code [3] 291860 0
Treatment: Other
Comparator / control treatment
The comparator will be the usual care group. Usual eye care for residents is informal although some facilities may use a mobile optometric unit to conduct yearly assessments.

The usual care group will not receive any intervention at baseline however quality of life questionnaires will be administered at Baseline, 2 month and 6 month.

At 6 month optometrists will conduct a comprehensive eye test.
Control group
Active

Outcomes
Primary outcome [1] 295053 0
To compare the effectiveness of ROC with usual care on presenting and best corrected near vision
Assessed with the Bailey Lovie Logmar near vision chart
Timepoint [1] 295053 0
2 and 6 months post intervention
Primary outcome [2] 295140 0
To determine the effectiveness of ROC on presenting best corrected distance vision.
Assessed with a Logmar Vision Chart
Timepoint [2] 295140 0
at 2 and 6 months post intervention
Secondary outcome [1] 314675 0
To determine the effectiveness of ROC on residential care-specific daily functioning.
Assessed with the IVI-RC questionnaire
Timepoint [1] 314675 0
1-2 and 6 months post intervention
Secondary outcome [2] 314676 0
To quantify the cost effectiveness of ROC at 6 months post intervention.

A cost effective analysis to quantify the health improvements gained relative to the resources expended will be conducted.
Timepoint [2] 314676 0
6 months post intervention
Secondary outcome [3] 314842 0
To determine the effectiveness of ROC on overall and vision specific quality of life.

Assessed with the EQ-5D and Quality of Vision questionnaire
Timepoint [3] 314842 0
1-2 and 6 month post intervention
Secondary outcome [4] 314843 0
To determine the effectiveness of ROC on depression assessed by the ACFI 10 - Cornell Scale for Depression questionnaire
Timepoint [4] 314843 0
1-2 and 6 months post intervention
Secondary outcome [5] 314844 0
To determine the effectiveness of ROC on rates of falls by obtaining data from the facility using a falls risk questionnaire
Timepoint [5] 314844 0
Collected for falls 3 months prior to baseline visit and 6 months after baseline visit
Secondary outcome [6] 314845 0
To determine the effectiveness of ROC on residents eye care utilisation. Using a questionnaire that asks them if they are using their eye care (eg. glasses, magnifiers), what activities they use them for and for how long.
intervention.
Timepoint [6] 314845 0
2 and 6 months post intervention

Eligibility
Key inclusion criteria
Inclusion Criteria
(i) Presenting distance vision of 6/15 or less and/or Near vision of N8 or less in both eyes
(ii) Ability to speak English
(iii) People deemed not cognitively impaired as determined by the Psychogeriatric Assessment Scale (PAS) questionnaire. A score of <15 in the PAS is deemed eligible.
(iv) Ability to undergo visual acuity testing and provide reliable results
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
(i) Presenting distance vision of 6/12 or better and/or Near vision of better than N8 in both eyes
(ii) Inability to speak English
(iii)People with a cognitive impairment as determined by the Psychogeriatric Assessment Scale (PAS) questionnaire. A score of >15 in the PAS is deemed ineligible.
(iii) Non-english speaking residents
(iv) inability to be tested for vision
(v) contraindication(s) as indicated by general practitioner responsible for residents care.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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)
Randomization schedules will be developed at the Centre for Eye Research Australia using a list of
computer generated pseudo-random numbers designed to yield expected assignment ratio of 1:1. For
logistical reasons and to minimise confounding effects, we will randomize by residential care facility into
ROC or usual care. This will be undertaken by the Project Manager and facilities will be informed of the
allocation after the screening consultations.
After the patient has given written informed consent, and screening and baseline data have been obtained
and passed eligibility review, the resident will be assigned an identification code made up of the residential
care facility, and a 3 digit no along with the patients’ initials.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/06/2014
Actual
18/06/2014
Date of last participant enrolment
Anticipated
1/06/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
395
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291272 0
Government body
Name [1] 291272 0
National Health Medical Record Council (NHMRC)
Country [1] 291272 0
Australia
Primary sponsor type
Other
Name
Centre for Eye Research Australia
Address
32 Gisborne Street
East Melbourne
VIC 3002
Country
Australia
Secondary sponsor category [1] 289945 0
None
Name [1] 289945 0
Address [1] 289945 0
Country [1] 289945 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292833 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 292833 0
Ethics committee country [1] 292833 0
Australia
Date submitted for ethics approval [1] 292833 0
Approval date [1] 292833 0
21/02/2014
Ethics approval number [1] 292833 0
R13-52AC

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

Contacts
Principal investigator
Name 57262 0
A/Prof Ecosse Lamoureux
Address 57262 0
Centre for Eye Research Australia
Level 1, 32 Gisborne Street
East Melbourne
VIC 3002
Country 57262 0
Australia
Phone 57262 0
+61 3 9929 8434
Fax 57262 0
Email 57262 0
[email protected]
Contact person for public queries
Name 57263 0
Marios Constantinou
Address 57263 0
Centre for Eye Research Australia
Level 1, 32 Gisborne Street
East Melbourne
VIC 3002
Country 57263 0
Australia
Phone 57263 0
+61 3 9929 8434
Fax 57263 0
Email 57263 0
[email protected]
Contact person for scientific queries
Name 57264 0
Marios Constantinou
Address 57264 0
Centre for Eye Research Australia
Level 1, 32 Gisborne Street
East Melbourne
VIC 3002
Country 57264 0
Australia
Phone 57264 0
+61 3 9929 8434
Fax 57264 0
Email 57264 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
SourceTitleYear of PublicationDOI
EmbaseImproving eye care in residential aged care facilities using the Residential Ocular Care (ROC) model: Study protocol for a multicentered, prospective, customized, and cluster randomized controlled trial in Australia.2018https://dx.doi.org/10.1186/s13063-018-3025-5
EmbaseEffectiveness of an innovative and comprehensive eye care model for individuals in residential care facilities: Results of the residential ocular care (ROC) multicentred randomised controlled trial.2020https://dx.doi.org/10.1136/bjophthalmol-2019-315620
N.B. These documents automatically identified may not have been verified by the study sponsor.