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Trial registered on ANZCTR


Registration number
ACTRN12614000038695
Ethics application status
Approved
Date submitted
2/01/2014
Date registered
16/01/2014
Date last updated
16/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of robot-assisted therapy on behavioural and psychological symptoms in community-living older adults with dementia
Scientific title
Effects of robot-assisted therapy using therapeutic robot Paro on behavioural and psychological symptoms in community-living older adults with moderate to severe dementia
Secondary ID [1] 283835 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 290812 0
Condition category
Condition code
Neurological 291180 291180 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 robot-assisted intervention once a week over an 8 week period (max: 30 minutes per session) provided by a trained research assistant/occupational therapist who is familiar with the Paro user manual. The Paro intervention will generally involve six stages/themes (Introduction of Paro, Baby-sitting Paro, Grooming Paro, Feeding Paro, Making over Paro, and Wardrobe Paro), but subjects are also free to interact with Paro whenever they wish.
Intervention code [1] 288519 0
Behaviour
Comparator / control treatment
This is a single group pre-post intervention study. No control group will be provided.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291169 0
Change of the Chinese version of Neuropsychiatric Inventory (CNPI) – apathy score after the intervention when compared with the baseline level (will be assessed with the Neuropsychiatric Inventory (NPI))
Timepoint [1] 291169 0
Baseline and post-intervention (8 weeks)
Secondary outcome [1] 306170 0
Change of other neuropsychiatric symptoms (will be assessed with the Neuropsychiatric Inventory (NPI))
Timepoint [1] 306170 0
Baseline and post-intervention (8 weeks)
Secondary outcome [2] 306171 0
Change of cognitive function (will be assessed using the Mini-Mental State Examination (MMSE))
Timepoint [2] 306171 0
Baseline and post-intervention (8 weeks)
Secondary outcome [3] 306172 0
Change of agitation behavior (will be assessed with the Cohen-Mansfield Agitation Inventory (CMAI))
Timepoint [3] 306172 0
Baseline and post-intervention (8 weeks)
Secondary outcome [4] 306173 0
Change of depression (will be assessed with the Corrnell Scale for Depression in Dementia (CSDD))
Timepoint [4] 306173 0
Baseline and post-intervention (8 weeks)
Secondary outcome [5] 306174 0
Change of moods (will be assessed with the simplified face scale)
Timepoint [5] 306174 0
Baseline and post-intervention (8 weeks)
Secondary outcome [6] 306175 0
Social interaction and communication (subjects’ emotion expression towards Paro (Responses) during intervention sessions will be charted on every-one-minute basis with an observation table by reviewing videotaped clips after each intervention session)
Timepoint [6] 306175 0
During intervention sessions
Secondary outcome [7] 306176 0
Change of caregiver burden (will be assessed with the Zarit burden interview (ZBI))
Timepoint [7] 306176 0
Baseline and post-intervention (8 weeks)

Eligibility
Key inclusion criteria
Community-living older adults aged 60 years and above will be screened using the Mini-Mental State Examination (CMMSE). Those who score between 5 and 15 with a diagnosis of dementia according to the criteria based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) will be screened for eligibility to the study. Severity of dementia will be determined using Clinical Dementia Rating (CDR). Subjects with CDR greater than or equal to 2 will be further assessed for the presence and severity of behavioural and psychological symptoms of dementia (BPSD) using Neuropsychiatric Inventory (NPI). To be clinically significant, those who exhibit any BPSD (have at least one documented behaviours occur at least once per week at a moderate severity level as defined on the NPI) 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
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5712 0
Hong Kong
State/province [1] 5712 0

Funding & Sponsors
Funding source category [1] 288492 0
Government body
Name [1] 288492 0
Health and Medical Research Fund
Country [1] 288492 0
Hong Kong
Primary sponsor type
Individual
Name
Ruby Yu
Address
Department of Medicine and Therapeutics, 10/F., Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 287195 0
None
Name [1] 287195 0
Address [1] 287195 0
Country [1] 287195 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 45266 0
Dr Ruby Yu
Address 45266 0
Department of Medicine and Therapeutics, 10/F., Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Country 45266 0
Hong Kong
Phone 45266 0
+852 26322190
Fax 45266 0
Email 45266 0
rubyyu@cuhk.edu.hk
Contact person for public queries
Name 45267 0
Ruby Yu
Address 45267 0
Department of Medicine and Therapeutics, 10/F., Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Country 45267 0
Hong Kong
Phone 45267 0
+852 26322190
Fax 45267 0
Email 45267 0
rubyyu@cuhk.edu.hk
Contact person for scientific queries
Name 45268 0
Ruby Yu
Address 45268 0
Department of Medicine and Therapeutics, 10/F., Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Country 45268 0
Hong Kong
Phone 45268 0
+852 26322190
Fax 45268 0
Email 45268 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.