Trial record 4 of 296 for:    "Skin cancer"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
April Armstrong, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01820234
First received: February 4, 2011
Last updated: March 25, 2013
Last verified: March 2013
  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: 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: April Armstrong, Asst Prof of Dermatology, Director of Clinical Research Unit, University of California, Davis
ClinicalTrials.gov Identifier: NCT01820234     History of Changes
Other Study ID Numbers: 201018315-1
Study First Received: February 4, 2011
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014