Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000399493
Ethics application status
Approved
Date submitted
2/08/2007
Date registered
3/08/2007
Date last updated
3/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of a low vision self-management program
Scientific title
A randomised controlled trial of a low vision self-management program on quality of life in people with low vision.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low vision due to eye disease 2209 0
Condition category
Condition code
Eye 2304 2304 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised to receive either the new low vision self-management program “Living with Low Vision” or continued access to usual low vision rehabilitation services.

The “Living with Low Vision” program has been developed specifically for this study. It consists of eight 3-hour weekly facilitated group sessions. The program is structured and a facilitator manual clearly outlines the content and delivery. As well as providing information, the topics in the program are covered by exploring participants’ experiences, difficulties and solutions. Participants are encouraged to draw on their extensive life experience and coping mechanisms and to develop new skills and strategies and apply these new techniques in their daily life. Participants are given the option to bring a relative, friend or carer to the program with them.
Intervention code [1] 1924 0
Rehabilitation
Comparator / control treatment

Usual low vision rehabilitation services consist of an initial assessment at a low vision clinic to discuss service goals and an optometric assessment and prescription of low vision devices. Clients have continued access to a multidisciplinary service team consisting of occupational therapy, orientation and mobility, orthoptics and welfare specialists. Additional support and information services are also available. Services are tailored to client goals.
Control group
Active

Outcomes
Primary outcome [1] 3199 0
The Impact of Vision Impairment Questionnaire (IVI) is used to assess the restriction of participation in daily activities in people with low vision (Lamoureux, Pallant, Pesudovs, Hassell, & Keeffe, 2006) The 28-item IVI has been extensively validated and has been shown to be sensitive to rehabilitation-induced changes in people with low vision.

The Depression Anxiety Stress Scale (DASS) is used to assess psychological well-being (Henry & Crawford, 2005; Lovibond & Lovibond, 2004). This is a 21-item self-report measure that provides three 7-item subscales of negative affect: depression, anxiety and stress.
Timepoint [1] 3199 0

All outcomes will be assessed at baseline, 4 months, 10 months and 16 months follow-up.
Secondary outcome [1] 5333 0
The General Self-Efficacy Scale (GSES) is used to assess general self-efficacy (Jerusalem & Schwarzer, 1992).
Timepoint [1] 5333 0
All outcomes will be assessed at baseline, 4 months, 10 months and 16 months follow-up.
Secondary outcome [2] 5334 0
The Positive and Negative Affect Schedule (PANAS) is used to assess the both positive and negative mood (Watson, Clark, & Tellegen, 1988).
Timepoint [2] 5334 0
All outcomes will be assessed at baseline, 4 months, 10 months and 16 months follow-up.
Secondary outcome [3] 5335 0
Adaptation to Age-related Vision Loss Scale (AVL-12) is used to assess psychosocial adaptation to vision loss, including acceptance of limitations, attitudes towards rehabilitation and appropriate help from family and friends (Horowitz & Reinhardt, 2006).
Timepoint [3] 5335 0
All outcomes will be assessed at baseline, 4 months, 10 months and 16 months follow-up.
Secondary outcome [4] 5336 0
The Health Education Impact Questionnaire (HEIQ) scales: ‘Skill and technique acquisition’ (five items) and ‘Positive and active engagement in life’ (five items) are used to determine the direct impact of the program on strategies to manage low vision and engagement in life (Nolte, Elsworth, Sinclair, & Osborne, 2006).
Timepoint [4] 5336 0
All outcomes will be assessed at baseline, 4 months, 10 months and 16 months follow-up.

Eligibility
Key inclusion criteria
Participants are clients of Vision Australia centres who have received a low vision assessment within the last 12 months and meet the following inclusion criteria:i. visual acuity of <6/12 and >6/480 in the better eye with habitual correctionii. age 55 years or olderiii. living independently (not in a nursing home)iv. english speakingv. no cognitive impairment as assessed by the 6 item cognitive impairment test (Brooke & Bullock, 1999) vi. adequate hearing to respond to normal conversation.
Minimum age
55 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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)
Participants are randomised following eligibility determination and baseline assessment. Allocation is conducted centrally by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are randomly assigned to one of the two groups using computer generated random sample selection by a researcher not involved in participant recruitment or assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Researchers conducting assesments are masked.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2468 0
Government body
Name [1] 2468 0
Australian Research Council Linkage Grant
Country [1] 2468 0
Australia
Funding source category [2] 2469 0
University
Name [2] 2469 0
Centre for Eye Research Australia
Country [2] 2469 0
Australia
Funding source category [3] 2470 0
Charities/Societies/Foundations
Name [3] 2470 0
Vision Australia
Country [3] 2470 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jill Keeffe
Address
Country
Secondary sponsor category [1] 2242 0
Individual
Name [1] 2242 0
Dr Ecosse Lamoureux
Address [1] 2242 0
Country [1] 2242 0
Secondary sponsor category [2] 2243 0
Individual
Name [2] 2243 0
Dr Gwyn Rees
Address [2] 2243 0
Country [2] 2243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4347 0
Royal Victorian Eye and Ear Hospital Human Research and Ethics Committee
Ethics committee address [1] 4347 0
Ethics committee country [1] 4347 0
Australia
Date submitted for ethics approval [1] 4347 0
Approval date [1] 4347 0
Ethics approval number [1] 4347 0

Summary
Brief summary
Study objectives
• To determine the effectiveness of the ‘Living with Low Vision’ program in improving vision-specific quality of life and emotional well-being at 4, 10 and 16 months following baseline assessment in comparison with a control group with access to usual rehabilitation services.
• To explore the impact of the ‘Living with Low Vision’ program on the uptake of rehabilitation services, use of low vision aids and devices, and home modification strategies.
• To explore factors are associated with beneficial outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27738 0
Address 27738 0
Country 27738 0
Phone 27738 0
Fax 27738 0
Email 27738 0
Contact person for public queries
Name 11113 0
Dr Gwyn Rees
Address 11113 0
Centre for Eye Research Australia
Department of Ophthalmology
University of Melbourne
Locked Bag 8
East Melbourne VIC 8002
Country 11113 0
Australia
Phone 11113 0
+61 3 99298673
Fax 11113 0
+61 3 96623859
Email 11113 0
[email protected]
Contact person for scientific queries
Name 2041 0
A/Professor Jill Keeffe
Address 2041 0
Centre for Eye Research Australia
Department of Ophthalmology
University of Melbourne
Locked Bag 8
East Melbourne VIC 8002
Country 2041 0
Australia
Phone 2041 0
+61 3 99298375
Fax 2041 0
+61 3 96623859
Email 2041 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
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