Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000942752
Ethics application status
Approved
Date submitted
22/08/2013
Date registered
26/08/2013
Date last updated
26/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Touch-screen video game technology on cognitive and behavioral symptoms for community-living older adults with mild to moderate dementia
Scientific title
Computer assisted intervention using touch-screen video game technology on cognitive and behavioral symptoms for community-living older adults with mild to moderate dementia
Secondary ID [1] 283055 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 289895 0
Condition category
Condition code
Neurological 290259 290259 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects assigned to the intervention group will be invited to participate in the computer assisted intervention 2 days a week over an 8 week period (45 minutes per session) provided by a trained research assistant. A selection of touch-screen video games will be used, including Able-X (mosquito splat), Brain Gym (mahjong flip and It’s going to rain), fun discovery and let’s find it etc.
Intervention code [1] 287777 0
Behaviour
Comparator / control treatment
Subjects assigned to the control group will receive conventional remedial activities such as pegboard games, card games, chess board etc. It will be conducted by a trained research assistant 2 days a week over an 8 week period and is expected to last for 45 minutes per session.
Control group
Active

Outcomes
Primary outcome [1] 290284 0
Change of the Chinese version of the Neuropsychiatric Inventory (CNPI) apathy score after the intervention when compared with the baseline level.
Timepoint [1] 290284 0
Baseline and post-intervention (8 weeks)
Secondary outcome [1] 304242 0
Cognitive function (will be measured by the Chinese version of the Mini-Mental State Examination (CMMSE))
Timepoint [1] 304242 0
Baseline and post-intervention (8 weeks)
Secondary outcome [2] 304293 0
Neuropsychiatric symptoms (will be measured by the Chinese version of Neuropsychiatric Inventory (CNPI))
Timepoint [2] 304293 0
Baseline and post-intervention (8 weeks)
Secondary outcome [3] 304294 0
Agitated behavior (will be measured by the Chinese version of the Cohen-Mansfield Agitation Inventory (CCMAI))
Timepoint [3] 304294 0
Baseline and post-intervention (8 weeks)
Secondary outcome [4] 304295 0
Depression (will be measured by the Chinese version of the Corrnell Scale for Depression in Dementia (CSDD))
Timepoint [4] 304295 0
Baseline and post-intervention (8 weeks)
Secondary outcome [5] 304296 0
Mood state (will be measured by a simplified face scale)
Timepoint [5] 304296 0
Baseline and post-intervention (8 weeks)
Secondary outcome [6] 304297 0
Social interaction and communication (subjects’ emotion expression towards video games and their participation will be charted on every-one-minute basis with the observation table by reviewing videotaped clips after each intervention session)
Timepoint [6] 304297 0
After each intervention session over 8 weeks

Eligibility
Key inclusion criteria
Community-living older adults aged 60 years and above will be screened using Chinese version of the Mini-Mental State Examination (CMMSE). Those who score between 13 and 23 will be further clinically adjudicated by a panel of clinical experts. Criteria for a diagnosis of dementia will be based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Severity of dementia will be determined using Clinical Dementia Rating (CDR). Only subjects with mild to moderate dementia (CDR 1 or 2) will be invited to participate.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if they have medical conditions severe enough to affect the patient’s ability to complete the treatment course and/or follow-up.

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)
This is a single blind randomized controlled trial. After eligibility check, subjects and their carergivers who agree to join the study will be randomly allocated into either the control or intervention group. Simple randomization will be adopted using computer-generated random numbers, sealed in an opaque envelope. Treatment assignment will be done by an independent person by opening the envelopes with consecutive numbers for eligible subjects. Subjects and their carergivers will aware of the treatment assigned. The outcome assessors will remain blinded to treatment allocation until the data entry is complete.
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
164
Accrual to date
Final
Recruitment outside Australia
Country [1] 5326 0
Hong Kong
State/province [1] 5326 0

Funding & Sponsors
Funding source category [1] 287819 0
Government body
Name [1] 287819 0
Health and Medical Research Fund
Country [1] 287819 0
Hong Kong
Primary sponsor type
Individual
Name
Ruby YU
Address
10/F, Clinical Sciences Building,
Prince of Wales Hospital, Shatin, Hong Kong.
Country
Hong Kong
Secondary sponsor category [1] 286549 0
None
Name [1] 286549 0
Address [1] 286549 0
Country [1] 286549 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 42314 0
Dr Ruby YU
Address 42314 0
Department of Medicine & Therapeutics,
10/F., Clinical Sciences Building,
Prince of Wales Hospital, Shatin, Hong Kong.
Country 42314 0
Hong Kong
Phone 42314 0
+852, 26322190
Fax 42314 0
Email 42314 0
rubyyu@cuhk.edu.hk
Contact person for public queries
Name 42315 0
Ruby YU
Address 42315 0
Department of Medicine & Therapeutics,
10/F., Clinical Sciences Building,
Prince of Wales Hospital, Shatin, Hong Kong.
Country 42315 0
Hong Kong
Phone 42315 0
+852, 26322190
Fax 42315 0
Email 42315 0
rubyyu@cuhk.edu.hk
Contact person for scientific queries
Name 42316 0
Ruby YU
Address 42316 0
Department of Medicine & Therapeutics,
10/F., Clinical Sciences Building,
Prince of Wales Hospital, Shatin, Hong Kong.
Country 42316 0
Hong Kong
Phone 42316 0
+852, 26322190
Fax 42316 0
Email 42316 0
rubyyu@cuhk.edu.hk

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.