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

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820234
• Other study ID #: 201018315
• Status: Completed
• Phase: N/A
• First received: February 4, 2011
• Last updated: July 17, 2017
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2013
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Screening
• Skin Cancer
• Skin Neoplasms
• Telemedicine

Intervention

Other:
• In-person dermatology evaluation
Every patient will be evaluated by an in person dermatologist present at the screening.
• Store-and-forward teledermatology evaluation
Every patient will be evaluated online via a store and forward teledermatology modality.

Locations

Country	Name	City	State
United States	University of California, Davis Shifa Community Clinic	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

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