Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000724370
Ethics application status
Approved
Date submitted
6/05/2017
Date registered
18/05/2017
Date last updated
18/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical skills assessment of a humanoid robot healthcare provider
Scientific title
Clinical skills assessment of a humanoid robot healthcare provider by healthcare staff and their perceptions to the same.
Secondary ID [1] 291364 0
Nil Known
Universal Trial Number (UTN)
U1111-1193-8366
Trial acronym
Robocare
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perceptions of robot healthcare delivery 303161 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302604 302604 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research team will recruit a minimum of 30 participants who will be adults, gender non-specific, working as health care providers (doctors, nurses, physiotherapists, pharmacist and others directly involved providing patient care) within the NWRH. There is no upper limit with regards to age of the participants.
Volunteer health workers and persons who do not provide direct patient care activities such as kitchen staff, cleaners and secretaries, will be excluded from participating.
The design of the 3-day study is prospective and observational and participants will:
Act as patients and interact with a Robot named NAO, a commercially available robot built by Aldebaran Robotics (58cm tall, weighing 4.3Kg).
Participant information will be provided to the study participants prior to their encounter with NAO and an informed consent will be obtained.
They will evaluate the Robot’s ability to interact as a clinical care provider, performing a simple breathing exercise as guided by the Robot using voice prompts and gestures.
Participants will then fill out a questionnaire at the end of their encounter with the Robot.
The above (both the interaction with NAO plus the completion of questionnnaire) is expected to take each participant approximately 15 minutes.
Participant answers will be analysed by the research team. NAO will not have any direct physical contact with the study participants and at times a robot engineer and a health professional involved in the study will be present with NAO.
Intervention code [1] 297989 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302018 0
A standardised questionnaire consisting of 7 individual questions designed for the study will be utilised. Each question will be ranked by the participants on a scale of 1 to 10 (1 being the lowest score and 10 being the highest).
Timepoint [1] 302018 0
On conclusion of the robot's encounter
Secondary outcome [1] 334521 0
None
Timepoint [1] 334521 0
None

Eligibility
Key inclusion criteria
Adults, gender non-specific, working as health care providers (doctors, nurses, physiotherapists, pharmacist and others directly involved providing patient care) within the NWRH, Burnie, Tasmania. There is no upper limit with regards to age of the participants.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers who do not provide direct clinical care

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A Likert Scale will be utilized for this purpose. Participants will provide their responses to 7 questions on a ranked scale from 1 to 10 (from lowest to highest). We will then calculate a total score and a mean score for the individual scale items. The Cronbach alpha test will be utilized to provide evidence that the components of the scale are sufficiently intercorrelated and to measure the degree of internal consistency. A Cronback Kappa test will be performed to measure inter-rater reliability. Data will be visualised with appropriate charts.

Given this being a perceptual study with no similar studies to compare, a sample size of minimum 30 is arbitrarily chosen

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/05/2017
Date of last participant enrolment
Anticipated
Actual
10/05/2017
Date of last data collection
Anticipated
Actual
10/05/2017
Sample size
Target
30
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 7941 0
North West Regional Hospital - Burnie
Recruitment postcode(s) [1] 15911 0
7320 - Burnie

Funding & Sponsors
Funding source category [1] 295835 0
Charities/Societies/Foundations
Name [1] 295835 0
Nurses Education Fund Northwest Regional Hospital
Country [1] 295835 0
Australia
Funding source category [2] 296372 0
Hospital
Name [2] 296372 0
Northwest Regional Hospital
Country [2] 296372 0
Australia
Primary sponsor type
Individual
Name
Dr. Balaji Bikshandi
Address
North west regional hospital
Intensive Care Unit
Brickport Road
Burnie
TAS 7320
Country
Australia
Secondary sponsor category [1] 294684 0
None
Name [1] 294684 0
Address [1] 294684 0
Country [1] 294684 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297118 0
University of Tasmania HREC
Ethics committee address [1] 297118 0
Ethics committee country [1] 297118 0
Australia
Date submitted for ethics approval [1] 297118 0
14/03/2017
Approval date [1] 297118 0
05/05/2017
Ethics approval number [1] 297118 0
H0016431

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

Contacts
Principal investigator
Name 73034 0
Dr Balaji Bikshandi
Address 73034 0
North west regional hospital
Intensive Care Unit
Brickport Road
Burnie
TAS 7320
Country 73034 0
Australia
Phone 73034 0
+61 3 6430 6666
Fax 73034 0
+61 2 61693070
Email 73034 0
balaji.md@gmail.com
Contact person for public queries
Name 73035 0
Balaji Bikshandi
Address 73035 0
North west regional hospital
Brickport Road
Burnie
TAS 7320
Country 73035 0
Australia
Phone 73035 0
+61 3 6430 6666
Fax 73035 0
+61 2 61693070
Email 73035 0
balaji.md@gmail.com
Contact person for scientific queries
Name 73036 0
Balaji Bikshandi
Address 73036 0
North west regional hospital
Brickport Road
Burnie
TAS 7320
Country 73036 0
Australia
Phone 73036 0
+61 3 6430 6666
Fax 73036 0
+61 2 61693070
Email 73036 0
balaji.md@gmail.com

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.