Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event

Not Applicable

Completed

• Conditions: Skin Cancer; Telemedicine; Screening
• Interventions: Other: In-person dermatology evaluation; Other: Store-and-forward teledermatology evaluation

• Registration Number: NCT01820234
• Lead Sponsor: University of California, Davis

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:

1. Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.

2. Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.

3. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-02-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
In-person dermatology evaluation	In-person dermatology evaluation	Health care modality
Store-and-forward teledermatology evaluation	Store-and-forward teledermatology evaluation	Health care modality

Primary Outcome Measures

Name	Time	Method
Aggregated diagnostic concordance	At the time of dermatologist evaluation (Day 1)	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

Name	Time	Method
Primary diagnostic concordance	At the time of dermatologist evaluation (Day 1)	Diagnostic concordance between the in-person dermatologist and the teledermatologist for their primary diagnosis.
Categorical diagnostic concordance	At the time of dermatologist evaluation (Day 1)	Diagnostic concordance between the in-person dermatologist and teledermatologist based on standard clinical diagnostic categories for each lesion.
Management concordance	At the time of dermatologist evaluation (Day 1)	The concordance between the in-person dermatologist and teledermatologist for the chosen management plan for each lesion.
Sensitivity	At the time of dermatologist evaluation (Day 1)	The sensitivity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.
Specificity	At the time of dermatologist evaluation (Day 1)	The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.

Trial Locations

Locations (1)

University of California, Davis Shifa Community Clinic; 🇺🇸 Sacramento, California, United States