Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000315819
Ethics application status
Approved
Date submitted
16/03/2012
Date registered
20/03/2012
Date last updated
20/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote consultation by video-conferencing for people with diabetes
Scientific title
Evaluation of accuracy of video tele-consultation for people with type II diabetes by comparing the recommendations made through videoconferencing with those of in-person consultation
Secondary ID [1] 280144 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Remote consultation for people with type II diabetes mellitus 286055 0
Condition category
Condition code
Public Health 286242 286242 0 0
Health service research
Metabolic and Endocrine 286300 286300 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People with type II diabetes who are referring to a diabetes clinic will be seen by endocrinologist consultant remotely via videoconferencing (real-time exchange of video and audio; a form of telemedicine). Duration of each consultation will be approximately 30 minutes.
Arm 1: Patient will be seen by 2 doctors - one by a face to face consultation and the other a video consultation (intervention). The order of in-person and video consultations will be based on random basis.
Arm 2: Patient will be seen by 2 doctors by two face to face consultations one following the other (control)
Intervention code [1] 284461 0
Diagnosis / Prognosis
Intervention code [2] 284502 0
Treatment: Other
Comparator / control treatment
Conventional in-person consultations provided by endocrinologist consultant for people with type II diabetes. Duration of each consultation will be approximately 30 minutes. Each participant will undergo two in-person consultations, one following the other.
Control group
Active

Outcomes
Primary outcome [1] 286741 0
Level of disagreement between recommendations made via videoconferencing and in-person consultation
Timepoint [1] 286741 0
After each consultation
Secondary outcome [1] 296564 0
Nil
Timepoint [1] 296564 0
Nil

Eligibility
Key inclusion criteria
Adult people with type II diabetes mellitus who are referring to diabetes clinic for review consultation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who are referring to the clinic for the first time, people whose first language is not English and no interpreter is available.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A research nurse will call people with type II diabetes who have fixed an appointment with the Princess Alexandra Hospital diabetes clinic and invite them for participation after introducing the study. Enrolment will be made at the diabetes clinic after obtaining written consent on the appointment day. Once enrolled, the participant will select a sealed envelope which will determine allocation to intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A table of random numbers will be generated using a random number generation software. Even numbers will donate allocation to intervention group and odd numbers to the control group. Each random number with corresponding allocated group will be printed on a sheet of paper and sealed in sequentially numbered opaque envelope. The set of envelopes will be kept in a box to be hold at the study site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284904 0
University
Name [1] 284904 0
The University of Queensland
Country [1] 284904 0
Australia
Primary sponsor type
University
Name
Centre for Online Health, The University of Queensland
Address
Level 3, Foundation Building
Royal Children's Hospital
Herston Road
Herston 4029
Queensland
Country
Australia
Secondary sponsor category [1] 283780 0
Hospital
Name [1] 283780 0
Diabetes and Endocrinology department, Princess Alexandra Hospital
Address [1] 283780 0
Princess Alexandra Hospital
Ipswich road
Woolloongabba
4102 QLD
Country [1] 283780 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286891 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 286891 0
Centres for Health Research
Princess Alexandra Hospital
Ipswich Road
Woolloongabba 4102 QLD
Ethics committee country [1] 286891 0
Australia
Date submitted for ethics approval [1] 286891 0
Approval date [1] 286891 0
12/03/2012
Ethics approval number [1] 286891 0
HREC/11/QPAH/645

Summary
Brief summary
Diabetes is a chronic disease which has no cure, instead optimal glycaemic control is required to minimize complications. However, only 40% of people with diabetes are achieving target glycaemic control, demonstrating that effective disease management for people with diabetes remains a challenge. For some, particularly in rural areas, not achieving target glycaemic controls is at least in part due to poor access to qualified health care providers. Telemedicine has been shown to be effective in improving access to care and lowering the costs in some disciplines, but its application in chronic diseases such as diabetes is still controversial.

This research project is designed to evaluate the accuracy and reliability of clinical decisions made when a diabetic patient is consulted by videoconference. This evaluation will be based on comparing the outcomes of specialist consultations provided through face-to-face encounter with video-consultation. Each patient will be seen by 2 doctors – either two face to face consultations one following the other, or a face to face and video consultation. Since doctors do not always agree on their decisions, this arrangement will enable us to determine whether any difference of opinion is a result of the video-conference method, or just normal variation between doctors.

If shown to be as reliable as face-to-face consultation for managing diabetes, there will be valuable evidence to support substituting in-person consultation with video-consultation, which paves the way for at least some specialist consultation for people living in rural areas to avoid the expense and inconvenience of long distance travel. In some cases, it may open the door for specialist advice that is currently not available.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33914 0
Address 33914 0
Country 33914 0
Phone 33914 0
Fax 33914 0
Email 33914 0
Contact person for public queries
Name 17161 0
Dr. Farhad Fatehi
Address 17161 0
Centre for Online Health
Level 3, Foundation Building
Royal Children's Hospital
Herston Road, Herston 4029
Queenland
Country 17161 0
Australia
Phone 17161 0
+61 7 3646 9456
Fax 17161 0
+61 7 3346 4705
Email 17161 0
[email protected]
Contact person for scientific queries
Name 8089 0
Dr. Farhad Fatehi
Address 8089 0
Centre for Online Health
Level 3, Foundation Building
Royal Children's Hospital
Herston Road, Herston 4029
Queenland
Country 8089 0
Australia
Phone 8089 0
+61 7 3646 9456
Fax 8089 0
+61 7 3346 4705
Email 8089 0
[email protected]

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.