Back to resultsEvaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
Primary Purpose
Skin Cancer, Screening, Telemedicine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-person dermatology evaluation
Store-and-forward teledermatology evaluation
Sponsored by
About this trial
This is an interventional screening trial for Skin Cancer focused on measuring Skin cancer, Teledermatology, Screening, Store-and-forward
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older at time of consent, may be male or female.
- Able to provide a brief medical history and have/allow an examination of their skin including photographs.
- Capable of giving informed consent.
- Will be able to receive notification of follow-up recommendations
Exclusion Criteria:
- Patients who will not provide informed consent
- Patient who are unable to fulfill tasks of this study
Sites / Locations
- University of California, Davis Shifa Community Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
In-person dermatology evaluation
Store-and-forward teledermatology evaluation
Arm Description
Health care modality
Health care modality
Outcomes
Primary Outcome Measures
Aggregated diagnostic concordance
Aggregated diagnostic concordance which is defined as the agreement of the in-person dermatologist's principle diagnosis with the teledermatologist's primary diagnosis or any of the differential diagnoses.
Secondary Outcome Measures
Primary diagnostic concordance
Diagnostic concordance between the in-person dermatologist and the teledermatologist for their primary diagnosis.
Categorical diagnostic concordance
Diagnostic concordance between the in-person dermatologist and teledermatologist based on standard clinical diagnostic categories for each lesion.
Management concordance
The concordance between the in-person dermatologist and teledermatologist for the chosen management plan for each lesion.
Sensitivity
The sensitivity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.
Specificity
The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.
Full Information
NCT ID
NCT01820234
First Posted
February 4, 2011
Last Updated
July 17, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT01820234
Brief Title
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
Official Title
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the diagnostic and management concordance of face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer screening event.
The investigators' hypotheses include the following:
Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.
Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.
The sensitivity and specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant will be similar to that of in-person evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer, Screening, Telemedicine
Keywords
Skin cancer, Teledermatology, Screening, Store-and-forward
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-person dermatology evaluation
Arm Type
Other
Arm Description
Health care modality
Arm Title
Store-and-forward teledermatology evaluation
Arm Type
Other
Arm Description
Health care modality
Intervention Type
Other
Intervention Name(s)
In-person dermatology evaluation
Intervention Description
Every patient will be evaluated by an in person dermatologist present at the screening.
Intervention Type
Other
Intervention Name(s)
Store-and-forward teledermatology evaluation
Other Intervention Name(s)
Health care modality
Intervention Description
Every patient will be evaluated online via a store and forward teledermatology modality.
Primary Outcome Measure Information:
Title
Aggregated diagnostic concordance
Description
Aggregated diagnostic concordance which is defined as the agreement of the in-person dermatologist's principle diagnosis with the teledermatologist's primary diagnosis or any of the differential diagnoses.
Time Frame
At the time of dermatologist evaluation (Day 1)
Secondary Outcome Measure Information:
Title
Primary diagnostic concordance
Description
Diagnostic concordance between the in-person dermatologist and the teledermatologist for their primary diagnosis.
Time Frame
At the time of dermatologist evaluation (Day 1)
Title
Categorical diagnostic concordance
Description
Diagnostic concordance between the in-person dermatologist and teledermatologist based on standard clinical diagnostic categories for each lesion.
Time Frame
At the time of dermatologist evaluation (Day 1)
Title
Management concordance
Description
The concordance between the in-person dermatologist and teledermatologist for the chosen management plan for each lesion.
Time Frame
At the time of dermatologist evaluation (Day 1)
Title
Sensitivity
Description
The sensitivity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.
Time Frame
At the time of dermatologist evaluation (Day 1)
Title
Specificity
Description
The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.
Time Frame
At the time of dermatologist evaluation (Day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years of age or older at time of consent, may be male or female.
Able to provide a brief medical history and have/allow an examination of their skin including photographs.
Capable of giving informed consent.
Will be able to receive notification of follow-up recommendations
Exclusion Criteria:
Patients who will not provide informed consent
Patient who are unable to fulfill tasks of this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
April W Armstrong, MD, MPH
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Shifa Community Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95818
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
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