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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
History of Changes
  Purpose

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.

Condition Intervention Phase
Atopic Dermatitis
 Other: Online Teledermatology Care
Other: Conventional in Office Care
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Comparison Between Asynchronous Online Care Model for the Management of Atopic Dermatitis With That of Face-to-Face, Office Visits

Resource links provided by NLM:

MedlinePlus related topics: Eczema
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Enrollment: 183
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teledermatology
Online Telemedicine Group
 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
Active Comparator: Usual Care
Conventional in-office care
 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

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985894

Locations
United States, California
UC Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: April W Armstrong, MD UC Davis Department of Dermatology
  More Information

No publications provided

Responsible Party: April Armstrong, Study Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00985894     History of Changes
Other Study ID Numbers: 200917162-1
Study First Received: September 25, 2009
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Teledermatology
Telemedicine
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013