Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000445673
Ethics application status
Approved
Date submitted
21/04/2014
Date registered
30/04/2014
Date last updated
29/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Playing Nintendo Wii with Australian Nursing Home Residents.
Scientific title
The Effects of Playing Nintendo Wii With Others on Depression, Sense of Belonging, Social Support and Mood in Australian Nursing Home Residents.
Secondary ID [1] 284463 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 291689 0
Sense of Belonging 291761 0
Social Support 291762 0
Mood 291763 0
Condition category
Condition code
Mental Health 292071 292071 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Residents will play Nintendo Wii with up to three other residents for six weeks. There will be 2 sessions per week, each session will run for up to one hour. The group will be playing Wii bowling. A researcher will supervisor and run all sessions.
Intervention code [1] 289218 0
Other interventions
Comparator / control treatment
Standard care as provided by the nursing home
Control group
Active

Outcomes
Primary outcome [1] 291946 0
Levels of depression in residents will be measured by the Geriatric Depression Scale.
Timepoint [1] 291946 0
Baseline, post-test after 6 weeks and after a 2 month follow up.
Primary outcome [2] 291948 0
Observational data on residents uptake, and use of the Nintendo Wii.
Timepoint [2] 291948 0
During the 6 week trial period and in a post-test Qualitative interview with residents.
Secondary outcome [1] 307904 0
Levels of social support will be measured by the Social Support Scale
Timepoint [1] 307904 0
Baseline, post-test after 6 weeks and after a 2 month follow up.
Secondary outcome [2] 307905 0
Sense of belonging and mood will be measured by visual analogue scales.
Timepoint [2] 307905 0
Baseline, post-test after 6 weeks and after a 2 month follow up.

Eligibility
Key inclusion criteria
Australian resident; currently residing in an aged care residential facility.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Written consent not or unable to be provided, Severe cognitive impairment, Diagnosis of bipolar affective disorder, Schizophrenia intellectual disability, Severe hearing impairment, Acute illness, Inability to communicate in English due to non-English speaking background, Epilepsy or seizures, Pacemaker or implanted medical device, Physical disability preventing use of the Wii console

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2014
Actual
31/01/2014
Date of last participant enrolment
Anticipated
Actual
4/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289108 0
University
Name [1] 289108 0
Federation University
Country [1] 289108 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive,
Mount Helen, VIC
3350
Country
Australia
Secondary sponsor category [1] 287774 0
None
Name [1] 287774 0
Address [1] 287774 0
Country [1] 287774 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290895 0
Federation Univeristy Human Research Ethics Commitee
Ethics committee address [1] 290895 0
Ethics committee country [1] 290895 0
Australia
Date submitted for ethics approval [1] 290895 0
Approval date [1] 290895 0
07/05/2013
Ethics approval number [1] 290895 0
A13-078

Summary
Brief summary
The Nintendo Wii console has been shown to provide both physical and cognitive benefits for the elderly. Playing Wii in groups can also provide an opportunity to interact with others, which may in turn encourage relationships to form. These relationships are based on shared interests and activities.
This research aims to investigate the mental health of elderly nursing home residents who are encouraged to participant in group activities involving the Wii console, compared with elderly residents with no intervention.
A sample of approximately 40 elderly adults aged 65 years and older who are currently living in a residential nursing home will be assigned to either the intervention group) or a control group (no intervention) based on their place of residence. Participants will complete a mental status examination eligibility questionnaire to determine if they have dementia or other health concerns preventing the use of the Wii. Demographics information, self-rated health scale, geriatric depression scale, social support provisional scale, intervention expectancy scale and three visual analogue scales measuring sense of belonging and mood will also be completed. The scores received on the Wii and time spent playing will be recorded by the residents. Residents will be invited to participate in a qualitative interview at the end of the intervention.
The results will provide a theoretical basis for future cost effective intervention programs to be implemented in nursing homes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47842 0
Miss Jessica Chesler
Address 47842 0
School of Health Sciences,
Federation University,
University Drive,
Mount Helen, VIC
3350
Country 47842 0
Australia
Phone 47842 0
+61 0417 558 999
Fax 47842 0
Email 47842 0
jessicachesler@students.federation.edu.au
Contact person for public queries
Name 47843 0
Jessica Chesler
Address 47843 0
School of Health Sciences,
Federation University,
University Drive,
Mount Helen, VIC
3350
Country 47843 0
Australia
Phone 47843 0
+61 0417 558 999
Fax 47843 0
Email 47843 0
jessicachesler@students.federation.edu.au
Contact person for scientific queries
Name 47844 0
Jessica Chesler
Address 47844 0
School of Health Sciences,
Federation University,
University Drive,
Mount Helen, VIC
3350
Country 47844 0
Australia
Phone 47844 0
+61 0417 558 999
Fax 47844 0
Email 47844 0
jessicachesler@students.federation.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
SourceTitleYear of PublicationDOI
EmbaseThe effects of playing Nintendo Wii on depression, sense of belonging and social support in Australian aged care residents: a protocol study of a mixed methods intervention trial.2015https://dx.doi.org/10.1186/s12877-015-0107-z
N.B. These documents automatically identified may not have been verified by the study sponsor.