Trial record 4 of 279 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014