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

NCT01820234 | Completed

• 1 other identifier: 201018315
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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. 1.Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.
2. 2.Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.
3. 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.

Conditions

Skin Cancer; Screening; Telemedicine

Keywords

Skin cancer; Teledermatology; Screening; Store-and-forward

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Primary diagnostic concordance

  At the time of dermatologist evaluation (Day 1)

• Categorical diagnostic concordance

  At the time of dermatologist evaluation (Day 1)

• Management concordance

  At the time of dermatologist evaluation (Day 1)

• Sensitivity

  At the time of dermatologist evaluation (Day 1)

• Specificity

  At the time of dermatologist evaluation (Day 1)

Study Arms (2)

In-person dermatology evaluation

OTHER

Health care modality

Other: In-person dermatology evaluation

Store-and-forward teledermatology evaluation

OTHER

Health care modality

Other: Store-and-forward teledermatology evaluation

Interventions

In-person dermatology evaluation OTHER

Every patient will be evaluated by an in person dermatologist present at the screening.

In-person dermatology evaluation

Store-and-forward teledermatology evaluation OTHER

Every patient will be evaluated online via a store and forward teledermatology modality.

Also known as: Health care modality

Store-and-forward teledermatology evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who will not provide informed consent
• Patient who are unable to fulfill tasks of this study

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Shifa Community Clinic

Sacramento, California, 95818, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• April W Armstrong, MD, MPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: March 28, 2013
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 19, 2017

Record last verified: 2013-03

Locations

US (1)