Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000782235
Ethics application status
Approved
Date submitted
6/07/2009
Date registered
9/09/2009
Date last updated
26/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of teledermoscopy as an alternative to face-to-face dermatological consultation in the diagnosis and management of patients referred to a skin lesion clinic
Scientific title
Evaluation of teledermoscopy as an alternative to face-to-face dermatological consultation in the diagnosis and management of patients referred to a skin lesion clinic
Secondary ID [1] 284164 0
nil known
Universal Trial Number (UTN)
Trial acronym
IMAGE IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
possibly malignant skin lesions 237165 0
Condition category
Condition code
Skin 237489 237489 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Teledermoscopy (taking close-up photographs of skin lesions with special equipment) takes 5-10 minutes. Immediately afterwards patients have a face-to-face consultation with a dermatology specialist lasting 10-15 minutes.
Intervention code [1] 236878 0
Diagnosis / Prognosis
Comparator / control treatment
All patients act as their own control by having teledermoscopy followed by a face-to-face consultation with a dermatology specialist.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238297 0
To assess the diagnostic concordance of teledermatology with face-to-face consultation and histopathological diagnosis
Timepoint [1] 238297 0
End of study
Secondary outcome [1] 244674 0
Acceptability of this specific teledermatology system, as assessed by patient questionnaires
Timepoint [1] 244674 0
End of study
Secondary outcome [2] 257325 0
Assess potential for changing patient management (such as triage) with the use of this specific teledermatology system
Timepoint [2] 257325 0
End of study

Eligibility
Key inclusion criteria
Patients referred from General Practitioners to the lesion diagnosis clinic
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lesions located over genital areas; lack of patient consent; inability to obtain adequate image e.g. in hair-bearing area, in concave site such as inner canthus

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients attending this clinic were offered the opportunity to enter the trial then, once consented, underwent both diagnostic procedures in the same sequence (teledermoscopy first then face-to-face consultation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Each participating subject is their own control, i.e. each subject has teledermoscopy first then a face-to-face consultation. Patient management is determined by the latter assessment. The study is evaluating the concordance in diagnosis (and separately in management) between teledermoscopy and face-to-face consultation to assess the potential for use of teledermoscopy as a triage tool to reduce the necessity for face-to-face consultation.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2008
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
7/11/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 1870 0
New Zealand
State/province [1] 1870 0

Funding & Sponsors
Funding source category [1] 237267 0
Charities/Societies/Foundations
Name [1] 237267 0
Waikato Medical Research Foundation
Country [1] 237267 0
New Zealand
Primary sponsor type
Individual
Name
Dr Eugene Tan
Address
Dermatology Department
Waikato Hospital
Pembroke St
Private Bag 3200
Waikato Mail Centre
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 236752 0
Individual
Name [1] 236752 0
Dr Michael Jameson
Address [1] 236752 0
Oncology Department
Waikato Hospital
Pembroke St
Private Bag 3200
Waikato Mail Centre
Hamilton 3240
Country [1] 236752 0
New Zealand
Other collaborator category [1] 743 0
Individual
Name [1] 743 0
Dr Amanda Oakley
Address [1] 743 0
Dermatology Department
Waikato Hospital
Pembroke St
Private Bag 3200
Waikato Mail Centre
Hamilton 3240
Country [1] 743 0
New Zealand
Other collaborator category [2] 744 0
Individual
Name [2] 744 0
Dr Marius Rademaker
Address [2] 744 0
Dermatology Department
Waikato Hospital
Pembroke St
Private Bag 3200
Waikato Mail Centre
Hamilton 3240
Country [2] 744 0
New Zealand
Other collaborator category [3] 745 0
Individual
Name [3] 745 0
Dr Anthony Yung
Address [3] 745 0
Dermatology Department
Waikato Hospital
Pembroke St
Private Bag 3200
Waikato Mail Centre
Hamilton 3240
Country [3] 745 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239367 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 239367 0
Ethics committee country [1] 239367 0
New Zealand
Date submitted for ethics approval [1] 239367 0
Approval date [1] 239367 0
26/02/2008
Ethics approval number [1] 239367 0
NTY/08/01/001

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

Contacts
Principal investigator
Name 29851 0
Dr Eugene Tan
Address 29851 0
Dermatology Department Waikato Hospital Pembroke St Private Bag 3200 Waikato Mail Centre Hamilton 3240
Country 29851 0
New Zealand
Phone 29851 0
+64 7 839 8899
Fax 29851 0
Email 29851 0
[email protected]
Contact person for public queries
Name 13098 0
Eugene Tan
Address 13098 0
Dermatology Department
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 13098 0
New Zealand
Phone 13098 0
+64 7 839 8899
Fax 13098 0
Email 13098 0
[email protected]
Contact person for scientific queries
Name 4026 0
Eugene Tan
Address 4026 0
Dermatology Department
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 4026 0
New Zealand
Phone 4026 0
+64 7 839 8899
Fax 4026 0
Email 4026 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.