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Trial registered on ANZCTR


Registration number
ACTRN12614000037606
Ethics application status
Approved
Date submitted
2/01/2014
Date registered
16/01/2014
Date last updated
17/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of robot-assisted therapy on moods, social interaction and communication in community-living older adults with dementia
Scientific title
Effects of robot-assisted therapy using therapeutic robot Paro on moods, social interaction and communication in community-living older adults with mild to moderate dementia
Secondary ID [1] 283833 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 290811 0
Condition category
Condition code
Neurological 291179 291179 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 a 6 week period (max: 30 minutes per session) provided by a trained research assistant/occupational therapist who is familiar with the Paro user manual. In each session, a structured, small-group approach in which a group of four subjects will be arranged to sit around a table with Paro in the centre and will be invited to interact with Paro. The intervention will involve six stages/themes (Introduction of Paro, Baby-sitting Paro, Grooming Paro, Feeding Paro, Making over Paro, and Wardrobe Paro).
Intervention code [1] 288518 0
Behaviour
Comparator / control treatment
Subjects assigned to the control group will receive usual care treatment (i.e, conventional cognitive and physically stimulation lifestyle activities). It will be run for weekly sessions for 30 minutes over six weeks.
Control group
Active

Outcomes
Primary outcome [1] 291168 0
Change of the simplified face scale score after the intervention when compared with the baseline level
Timepoint [1] 291168 0
Baseline and post-intervention (6 weeks)
Secondary outcome [1] 306166 0
Change of cognitive function (will be assessed using the Mini-Mental State Examination (MMSE))
Timepoint [1] 306166 0
Baseline and post-intervention (6 weeks)
Secondary outcome [2] 306167 0
Change of depression (will be assessed with the Corrnell Scale for Depression in Dementia (CSDD))
Timepoint [2] 306167 0
Baseline and post-intervention (6 weeks)
Secondary outcome [3] 306168 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 [3] 306168 0
During intervention sessions
Secondary outcome [4] 306169 0
Change of caregiver burden (will be assessed with the Zarit burden interview (ZBI))
Timepoint [4] 306169 0
Baseline and post-intervention (6 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 10 and 24 with a diagnosis of dementia will be screened for eligibility to the study. 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). Subjects with mild to moderate dementia (CDR 1 or 2) will be further assessed for the presence of behavioral and psychological symptoms of dementia (BPSD) using Cohen-Mansfield Agitation Inventory (CMAI). Only subjects without BPSD 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
Those who exhibit any BPSD (CMAI total score greater than or equal to 2) will be excluded from the study. Subjects will also 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)
This is a single-blind randomized controlled trial (RCT) comparing Paro therapy and usual care. Subject recruitment will be occurred mainly through clinical referrals from different clinical settings. Those who are potentially eligible and interested to participate will be referred to us for eligibility confirmation. Informed consent will be obtained from every eligible subject agreeing to participate. When a subject is unable to give informed consent, proxy consent will be obtained.

After written informed consent, subjects will be randomly allocated into either the intervention or control 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 will aware of the treatment assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 5711 0
Hong Kong
State/province [1] 5711 0

Funding & Sponsors
Funding source category [1] 288491 0
Government body
Name [1] 288491 0
Health and Medical Research Fund
Country [1] 288491 0
Hong Kong
Primary sponsor type
Individual
Name
Ruby Yu
Address
10/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 287192 0
None
Name [1] 287192 0
Address [1] 287192 0
Country [1] 287192 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 45262 0
Dr Ruby Yu
Address 45262 0
Department of Medicine and Therapeutics, 10/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Country 45262 0
Hong Kong
Phone 45262 0
+852 26322190
Fax 45262 0
Email 45262 0
rubyyu@cuhk.edu.hk
Contact person for public queries
Name 45263 0
Ruby Yu
Address 45263 0
Department of Medicine and Therapeutics, 10/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Country 45263 0
Hong Kong
Phone 45263 0
+852 26322190
Fax 45263 0
Email 45263 0
rubyyu@cuhk.edu.hk
Contact person for scientific queries
Name 45264 0
Ruby Yu
Address 45264 0
Department of Medicine and Therapeutics, 10/F, Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Country 45264 0
Hong Kong
Phone 45264 0
+852 26322190
Fax 45264 0
Email 45264 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.