ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12608000571370

Ethics application status

Approved

Date submitted

1/09/2008

Date registered

12/11/2008

Date last updated

6/11/2013

Type of registration

Retrospectively registered

Titles & IDs

Public title

ENvironment and Vision Optimisation in Residential Care (EnVORC)

Scientific title

Effectiveness of vision intervention, environmental modification, and staff training targeting vision factors; to improve vision, independence, safety and quality of life in the residential care setting.

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

ENvironment and Vision Optimisation in Residential Care (EnVORC)

Linked study record

Health condition

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

Vision

Physical environment in residential care facility/s

Residents' Independence in residential care setting

Safety in residential care setting

Quality of Life in residential care setting

Condition category

Condition code

Eye

Diseases / disorders of the eye

Mental Health

Depression

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Implementation of a targeted intervention plans to address individuals' and facilities' environmental factors influencing vision and the environment to improve residents' safety, function and quality or life in participating facilities. Interventions include provision of magnification glasses, referral to optometrist/ opthalmologist/ general practitioner (GP), environmental modification of facility (eg improvement in lighting), and staff training related to vision and residential care (staff training was a one hour session of demonstration and experiential learning, supported with a resource kit for ongoing review.). The full intervention took approximately six months.

Intervention code [1]

Other interventions

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

environmental hazards in residental care facilities and residents' bedrooms (Improving the environment for older people in health services audit tool - Victorian Department of Human Services)

Timepoint [1]

baseline and post intervention

Primary outcome [2]

Residents' quality of life as assessed on the "Nursing home, vision targeted, health related, quality of life questionnaire' (NHVQoL)

Timepoint [2]

baseline and post intervention

Secondary outcome [1]

Safety and Falls, as recorded by facilities' incident reports

Timepoint [1]

baseline and post intervention

Secondary outcome [2]

Residents' physical function as assessed on the deMorton Mobility Index (DEMMI)

Timepoint [2]

baseline and post intervention

Secondary outcome [3]

Residents' depression levels as assessed from the Cornell and Patient Health Questionnaire-9 (PHQ-9) scales

Timepoint [3]

baseline and post intervention

Secondary outcome [4]

Environmental audit, using the tool "Improving the environment for older people in health services: an audit tool"

Timepoint [4]

baseline and post intervention

Eligibility

Key inclusion criteria

Resident of low care participating residential facility or high care resident within participating low care facility that has ageing in place.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Not fitting inclusion criteria

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

Other

Other design features

Individually tailored intervention based on participants' vision screening and environmental assessments.
Implementional of facility improvements based on environmental audit tool.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2008

Actual

25/02/2008

Date of last participant enrolment

Anticipated

Actual

29/04/2008

Date of last data collection

Anticipated

Actual

Sample size

Target

189

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3134

Recruitment postcode(s) [2]

3228

Recruitment postcode(s) [3]

3015

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Eye Health Demonstration Grants Program, Australian Government Department of Health and Ageing

Address [1]

Department of Health and Ageing
Central Office
GPO Box 9848
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

National Ageing Research Institute

Address

PO Box 2127
Royal Melbourne Hospital
Parkville 3050

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Centre for Eye Research Australia

Address [1]

University of Melbourne
32 Gisborne St
East Melbourne 3002

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Barwon Health Research and Ethics Advisory Committee

Ethics committee address [1]

The Geelong Hospital
Ryrie St PO Box 281
Geelong 3220
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/11/2007

Ethics approval number [1]

07/81

Summary

Brief summary

This collaborative project between National Ageing Research Institute (NARI) and the Centre for Eye Research Australia (CERA) addresses vision related needs for older people in low-level residential care.  The project involves three facilities; one in Geelong and two in Melbourne.  The project aims to screen residents to quantify the magnitude of vision impairment among people in residential aged care facilities, and to conduct environmental audits to determine the extent of environmental factors influencing function and quality of life in this setting. Following this, a collaborative approach with each facility’s key staff members, residents and carers will determine how the problems identified will be addressed. 

Interventions will include: referral for further assessment where indicated; provision of corrective lenses for those with correctable visual impairments; environmental modification to address factors affecting function and safety; staff training about screening and management / referral options for residents with visual impairment (including consideration of environmental factors for residents with impaired vision) and information for residents and carers to maximise vision and environmental safety.

In order to assess the effectiveness of the management plans, data will be collected (before and after the intervention) about falls rates, vision screening, environmental hazards and residents’ functional status and wellbeing.

Key learnings from the project will be compiled as user-friendly resources that can be accessed by other residential care facilities enabling them to adopt a similar approach.  The project will be undertaken over 18 months and is due for completion in February 2009.

Trial website

Trial related presentations / publications

Lamoureux, E. L., E. Fenwick, et al. (2009). "Impact of the severity distance and near vision impairment on depression and vision-specific quality of life in older people living in residential care." Investigative Ophthalmology & Visual Science 50(9): 4103-4109.

Moore, K., K. Borschmann, et al. (2009). ENvironment and Vision Optimisation in Residential Care (EnVORC). Project report by the National Ageing Research Institute and the Centre for Eye Research Australia to the Australian Government Department of Health and Ageing.

Moore, K., E. Lamoureux, et al. (2009). Environment and Vision Optimisation in Residential Care (ENVORC). Aged Care Standards and Accreditation Agency's Better Practice Event, Melbourne.

Moore, K., E. Lamoureux, et al. (2009). Are Vision and Environmental factors adequately addressed in low level residential aged care facilities? . 18th Annual Tri-State Conference, Albury.

Public notes

Contacts

Principal investigator

Name

Prof Keith Hill

Address

National Ageing Research Institute Preventive and Public Health Division, Building 8, Gate 4, 34-54 Poplar Rd, Parkville, Victoria 3052

Country

Australia

Phone

+61 3 8387 2626

Fax

Email

k.hill@nari.unimelb.edu.au

Contact person for public queries

Name

Professor Keith Hill

Address

National Ageing Research Institute
Preventive and Public Health Division
PO Box 2127
Royal Melbourne Hospital 3050

or Gate 4, 34-54 Poplar Rd
Building 8

Country

Australia

Phone

+61 3 8387 2626

Fax

+61 3 8387 2153

Email

k.hill@nari.unimelb.edu.au

Contact person for scientific queries

Name

Professor Keith Hill

Address

National Ageing Research Institute
Preventive and Public Health Division
PO Box 2127
Royal Melbourne Hospital 3050

or Gate 4, 34-54 Poplar Rd
Building 8

Country

Australia

Phone

+61 3 8387 2626

Fax

+61 3 8387 2153

Email

k.hill@nari.unimelb.edu.au

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.