Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000614796
Ethics application status
Not yet submitted
Date submitted
28/05/2013
Date registered
29/05/2013
Date last updated
29/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of bright light therapy to improve mood in residential care
Scientific title
A randomised controlled trial of bright light therapy to improve mood in residents in residential aged care
Secondary ID [1] 282546 0
Nil known
Universal Trial Number (UTN)
U1111-1143-3342
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive symptoms
 289215 0
Cognitive decline 289216 0
Condition category
Condition code
Mental Health 289550 289550 0 0
Depression
Neurological 289551 289551 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will spend 1 hour in a room fitted with bright lights that provide 2000-3000 lux at eye level. Light intensity will be measured using a calibrated light meter. The room has space for six residents and one staff member, with a central table and toilet facilities located adjacent to the room. The bright light exposure period will be from 10am-11am, Monday to Friday for two weeks. While in the room, a staff member will be present and will provide residents with morning tea and conduct social activities or assist residents as needed. Residents will be encouraged to remain in the room for the one hour period; however if they wish to leave they will not be prevented from doing so. The residential aged care facility has 2 floors with the same living room on each floor to be used for the study - on one floor the room is fitted with bright lights for the intervention group. This will also enable bright light and usual light groups to occur at the same time.
Intervention code [1] 287216 0
Treatment: Other
Comparator / control treatment
Participants will spend 1 hour in a room fitted with standard lights (300-500 lux at eye level). Light intensity will be measured using a calibrated light meter. The room has space for six residents and one staff member, with a central table and toilet facilities located adjacent to the room. The usual light exposure period will be from 10am-11am, Monday to Friday for two weeks. While in the room, a staff member will be present and will provide residents with morning tea and conduct social activities or assist residents as needed. Residents will be encouraged to remain in the room for the one hour period; however if they wish to leave they will not be prevented from doing so.
Control group
Active

Outcomes
Primary outcome [1] 289641 0
Depression as measured by a score of 5 or more on the Geriatric Depression Scale - 15 item version.
Timepoint [1] 289641 0
Assessed in the week following the intervention period
Secondary outcome [1] 302926 0
ADL status: Modified Barthel Index
Timepoint [1] 302926 0
Assessed in the week following the intervention period
Secondary outcome [2] 303039 0
Depression in Dementia: Cornell Scale for Depression in Dementia
Timepoint [2] 303039 0
Assessed in the week following the intervention period
Secondary outcome [3] 303040 0
Cognition: Standardised Mini Mental State Examination
Timepoint [3] 303040 0
Assessed in the week following the intervention period
Secondary outcome [4] 303041 0
Quality of Life: Six Dimensional Assessment of Quality of Life tool (20 item)
Timepoint [4] 303041 0
Assessed in the week following the intervention period
Secondary outcome [5] 303042 0
Neuropsychiatric Symptoms: Neuropsychiatric Inventory – Nursing Home version
Timepoint [5] 303042 0
Assessed in the week following the intervention period

Eligibility
Key inclusion criteria
-Vasey RSL Brighton East residents.
-Residents with low mood who have capacity to consent, or who have a person responsible who is able to provide consent.
-Residents who are able to be transported to the light therapy room or equivalent and able to remain in the room for a one hour period.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Residents who are receiving palliative care
-Residents with severe eye disease
-Residents who require a secure facility

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Residents identified by staff as having low mood will be invited to participate. Consent will be sought from the resident and/or person responsible. Following the baseline assessment, participants will be randomised to the intervention or control group. Allocation will involve contacting the holder of the allocation schedule who is off-site from the residential aged care facility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number sequence will determine group allocation and project staff will be informed. Randomisation will occur in blocks as the intervention can only be conducted with a limited number of people at a time.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcome measure will be the GDS. Based on a reduction in the presence of depression (as defined by a score of 5 or more on the GDS) to 60% in the intervention group, and no change in the control group, 15 participants in each group will be required (80% power, alpha 0.05, 2 tailed). Allowing for drop-outs, 18 people in each group need to be recruited. All data will be analysed using intention to treat analysis. The difference in the presence of depression between the control group and intervention group will be analysed using chi-square analysis. To analyse the effect of the intervention on secondary outcomes, linear regression will be used for continuous variables, and logistic regression used for categorical variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
30/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6924 0
3187 - Brighton East

Funding & Sponsors
Funding source category [1] 287368 0
Charities/Societies/Foundations
Name [1] 287368 0
Lord Mayors Charitable Foundation
Country [1] 287368 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
GPO Box 2127
Royal Melbourne Hospital
Victoria 3050
Country
Australia
Secondary sponsor category [1] 286112 0
None
Name [1] 286112 0
Address [1] 286112 0
Country [1] 286112 0
Other collaborator category [1] 277439 0
Commercial sector/Industry
Name [1] 277439 0
Vasey RSL Care
Address [1] 277439 0
172 Burwood Road
Hawthorn
Victoria 3122
Country [1] 277439 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289342 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 289342 0
Ethics committee country [1] 289342 0
Australia
Date submitted for ethics approval [1] 289342 0
29/05/2013
Approval date [1] 289342 0
Ethics approval number [1] 289342 0
2013.131

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

Contacts
Principal investigator
Name 40254 0
Dr Kirsten Moore
Address 40254 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital
Vic 3050
Country 40254 0
Australia
Phone 40254 0
61 3 8387 2200
Fax 40254 0
Email 40254 0
[email protected]
Contact person for public queries
Name 40255 0
Kirsten Moore
Address 40255 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital
Vic 3050
Country 40255 0
Australia
Phone 40255 0
61 3 8387 2200
Fax 40255 0
Email 40255 0
[email protected]
Contact person for scientific queries
Name 40256 0
Kirsten Moore
Address 40256 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital
Vic 3050
Country 40256 0
Australia
Phone 40256 0
61 3 8387 2200
Fax 40256 0
Email 40256 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
No additional documents have been identified.