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Comparison Between Asynchronous Online Care Model With Usual In Office Care for the Management of Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
April Armstrong, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00985894
First received: September 25, 2009
Last updated: June 18, 2012
Last verified: June 2012

September 25, 2009
June 18, 2012
September 2009
March 2012   (final data collection date for primary outcome measure)
  • Eczema Area and Severity Index (EASI) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Patient-oriented Eczema Measure (POEM) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00985894 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison Between Asynchronous Online Care Model With Usual In Office Care for the Management of Atopic Dermatitis
Comparison Between Asynchronous Online Care Model for the Management of Atopic Dermatitis With That of Face-to-Face, Office Visits

The purpose of this study is to determine if an asynchronous online model of teledermatology can achieve similar clinical outcomes as compared to conventional in-office care for the management of atopic dermatitis. The investigators also aim to determine the effects of this online care model on patient quality of life as well as patient and physician satisfaction.

The investigators' hypotheses include the following:

  1. Compared to in-person visits, the online care model will result in similar clinical improvement in atopic dermatitis disease severity.
  2. Compared to in-person visits, the online care model will result in similar improvements in quality of life.
  3. Providers and subjects in the online group will achieve a similar level of overall satisfaction as those in the in-person group.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Atopic Dermatitis
  • Other: Online Teledermatology Care
    Patients randomized to the intervention group will have their scheduled follow-up visits online via store and forward teledermatology.
    Other Name: Health care service modality
  • Other: Conventional in Office Care
    Patients randomized to the control group will have their scheduled follow-up visits via conventional in office care.
    Other Name: Health care service modality
  • Experimental: Teledermatology
    Online Telemedicine Group
    Intervention: Other: Online Teledermatology Care
  • Active Comparator: Usual Care
    Conventional in-office care
    Intervention: Other: Conventional in Office Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged 4 years or older at time of consent, may be male or female.
  • Meet the Hanifin diagnostic criteria for atopic dermatitis.
  • Capable of giving informed consent (for patients less than 18 years of age, assent will be obtained from the minor and informed consent will be obtained from a legal guardian).
  • Able to image their skin or have someone do it for them.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Have access to a computer with internet connection, a digital camera, and an e-mail address.

Exclusion Criteria:

  • Non English speaking patients.
  • Patients requiring systemic treatment (e.g., cyclosporine, phototherapy).
  • Patients requiring close laboratory monitoring.
Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00985894
200917162-1
No
April Armstrong, University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: April W Armstrong, MD UC Davis Department of Dermatology
University of California, Davis
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP