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Trial registered on ANZCTR


Registration number
ACTRN12611000462987
Ethics application status
Approved
Date submitted
2/05/2011
Date registered
4/05/2011
Date last updated
1/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE): A randomised controlled trial of humour therapy in residential care
Scientific title
Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE): A randomised controlled trial of humour therapy for improving quality of life outcomes in aged persons with dementia in residential care.
Secondary ID [1] 260098 0
nil
Universal Trial Number (UTN)
Trial acronym
SMILE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation, behavioural disturbance and lack of social engagement 270462 0
Depressed mood in dementia 243550 0
Quality of life in residential aged care 243551 0
Condition category
Condition code
Neurological 265929 265929 0 0
Dementias
Mental Health 239854 239854 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
About 400 residents living in 36 hostels and nursing homes will be randomly assigned (at the level of facility) to receive the SMILE intervention or usual care. The SMILE intervention will comprise a 1-day training woprkshop for a staff member nominated by the facility to act as the LaughterBoss for that facility. The training session will be run at a central location off-site in small group experiential learning format, facilitated by an experienced humour therapy practitioner. It will address how to incorporate humour into daily care practices with residents. The LaughterBoss will then partner with an ElderClown (a performer experienced in using humour in health care settings) to engage residents through humour using music, mime, props and other techniques. ElderClowns will visit facilities over 12 weeks for humour therapy sessions lasting 2 hours on each visit, with each facility receiving a minimum of 9 sessions. LaughterBosses will be encouraged to continue to use humour techniques between weekly ElderClown visits and after the program of visits has ceased. SMILE will evaluate whether humour therapy improves resident mood and quality-of-life.
Intervention code [1] 241157 0
Behaviour
Comparator / control treatment
Aged care facilities assigned to the control group will provide usual care for residents with respect to the assessment and management of depresssion and other behavioural issues. Usual care will be in line with each facility's care plan, and the regular assessment processes as prescribed by the Aged Care Funding Instrument in NSW Health (ACFI). At the end of the trial, the staff in the control group will be provided with the same one-day (delayed) training workshop for the volunteer staff nominated as LaughterBosses, as per the intervention group. There will be no ElderClown on-site visits for the control group.
Control group
Active

Outcomes
Primary outcome [1] 240626 0
Social engagement and agitation will be assessed using the 8-item social engagement subscale of the 40-item Multidimensional Observation Scale for Elderly Subjects (MOSES) and the Cohen-Mansfield Agitation Inventory (CMAI, 29 items). These measures will be completed via interview with an informant. The informant will be a person familiar with the resident's usual behaviour, such as a carer employed at the aged care facility, a legal guardian or family member.
Timepoint [1] 240626 0
at baseline (pre-intervention), 12 weeks post intervention, and 12 weeks followup
Primary outcome [2] 240624 0
Depression will be assessed by the researcher using the Cornell Depression Inventory. The item format will be the same as that adopted in the depression category assessment within the Aged Care Funding Instrument (ACFI; Section 10). The ACFI was introduced by the Australian Government in residential aged care in March 2008
Timepoint [2] 240624 0
at baseline (pre-intervention), 12 weeks post intervention, and 12 weeks followup
Primary outcome [3] 240625 0
Quality of life wil be assessed using the DEMQOL version 4, using both the self-report (DEMQOL, 29 item) and informant (DEMQOL-proxy, 32 item) formats. This measure will completed via interview with an informant, and where possible, the resident. The informant will be a person familiar with the resident's usual behaviour, such as a carer employed at the aged care facility, a legal guardian or family member.
Timepoint [3] 240625 0
at baseline (pre-intervention), 12 weeks post intervention, and 12 weeks followup
Secondary outcome [1] 257261 0
A computer-assisted tool for real-time observation of behavioural and social engagement will be used. Developed by the research team, and using some principles of Dementia Care Mapping (DCM) , this behaviour, engagement, and agitation measure (BEAM) will be used by the researchers to record brief observations in three activity profiles for each resident: during a mealtime, a structured activity, and free time.
Timepoint [1] 257261 0
at baseline (pre-intervention), 12 weeks post intervention, and 12 weeks followup during structured activities, meals, and free time

Eligibility
Key inclusion criteria
Permanent residents in Australian Government approved and accredited residential aged/dementia care services providing low or high care for residents with dementia, accessible by sealed road, located in greater Sydney.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Younger than 50 years of age

Less than 3 months since admission to fulltime residential care

In respite care not fulltime residental care

Multiple communication impairements corresponding with 2 out of 3 of aphasic, blind, and/or deaf

Non-English speaking with no bilingual informant available

In palliative care or terminally ill with life expectancy less than 6 months relative to study commencement at that facility

Scheduled to move from the facility within 6 months of study commencement at that facility

Acutely physically unwell at time of assessment

Floridly symptomatic at the time of assessment (in the psychiatric sense)

Bedbound and noncommunicative (i.e. vegetative state)

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)
Thirty-six RACF units will be stratified by size (small=18 beds or less, large=greater than 18 beds) and care type (high or low care) to ensure balance across treatment groups and to allow testing of whether the effects of humour therapy differ across strata. Units within each stratum will be assigned a number and then randomised to receive the humour intervention or usual care. Randomisation will occur after all the facilities have been recruited, however the group to which the units have been allocated will not be revealed to other study staff or RACFs until consent for individual residents has been obtained and baseline assessments have been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
cluster randomised trial - unit of randomisation is facility, not residents withing facility
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237524 0
Government body
Name [1] 237524 0
National Health and Medical Research Council (NHMRC)
Country [1] 237524 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
The University of New South Wales
SYDNEY
NSW 2052
Country
Australia
Secondary sponsor category [1] 264099 0
University
Name [1] 264099 0
University of Technology
Address [1] 264099 0
University of Technology, Sydney
P.O. Box 123
Broadway, NSW 2007
Australia
Country [1] 264099 0
Australia
Secondary sponsor category [2] 264100 0
Charities/Societies/Foundations
Name [2] 264100 0
Humour Foundation
Address [2] 264100 0
Suite 3.5
126 Greville Street
Chatswood NSW 2067
Country [2] 264100 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243654 0
University of New South Wales
Ethics committee address [1] 243654 0
Ethics committee country [1] 243654 0
Australia
Date submitted for ethics approval [1] 243654 0
20/01/2009
Approval date [1] 243654 0
27/01/2009
Ethics approval number [1] 243654 0
08345

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

Contacts
Principal investigator
Name 30073 0
Address 30073 0
Country 30073 0
Phone 30073 0
Fax 30073 0
Email 30073 0
Contact person for public queries
Name 13320 0
Professor Henry Brodaty
Address 13320 0
Dementia Collaborative Research Centre
School of Psychiatry
Faculty of Medicine
Level 3, AGSM Building
The University of New South Wales
SYDNEY NSW 2052
Country 13320 0
Australia
Phone 13320 0
+61 2 9385 2595
Fax 13320 0
Email 13320 0
h.brodaty@unsw.edu.au
Contact person for scientific queries
Name 4248 0
Dr Lee-Fay Low
Address 4248 0
Dementia Collaborative Research Centre
School of Psychiatry
Faculty of Medicine
Level 3, AGSM Building
The University of New South Wales
SYDNEY NSW 2052
Country 4248 0
Australia
Phone 4248 0
+61 2 9385 2599
Fax 4248 0
Email 4248 0
lf.low@unsw.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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes2013https://doi.org/10.1136/bmjopen-2012-002072
EmbaseSuccessful ingredients in the SMILE study: Resident, staff, and management factors influence the effects of humor therapy in residential aged care.2014https://dx.doi.org/10.1016/j.jagp.2013.08.005
EmbaseThe Effects of Humor Therapy on Nursing Home Residents Measured Using Observational Methods: The SMILE Cluster Randomized Trial.2014https://dx.doi.org/10.1016/j.jamda.2014.03.017
N.B. These documents automatically identified may not have been verified by the study sponsor.