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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01820234
First Posted: March 28, 2013
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
  Purpose

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.

Condition Intervention
Skin Cancer Screening Telemedicine Other: In-person dermatology evaluation Other: Store-and-forward teledermatology evaluation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Aggregated diagnostic concordance [ Time Frame: 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:
  • Primary diagnostic concordance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At the time of dermatologist evaluation (Day 1) ]
    The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.


Enrollment: 170
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
In-person dermatology evaluation
Health care modality
Other: In-person dermatology evaluation
Every patient will be evaluated by an in person dermatologist present at the screening.
Store-and-forward teledermatology evaluation
Health care modality
Other: Store-and-forward teledermatology evaluation
Every patient will be evaluated online via a store and forward teledermatology modality.
Other Name: Health care modality

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820234


Locations
United States, California
University of California, Davis Shifa Community Clinic
Sacramento, California, United States, 95818
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: April W Armstrong, MD, MPH University of California, Davis
  More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01820234     History of Changes
Other Study ID Numbers: 201018315
First Submitted: February 4, 2011
First Posted: March 28, 2013
Last Update Posted: July 19, 2017
Last Verified: March 2013

Keywords provided by University of California, Davis:
Skin cancer
Teledermatology
Screening
Store-and-forward

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases