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

May 24, 2017 updated by: University of California, Davis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • UC Davis Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Health care service modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eczema Area and Severity Index (EASI)
Time Frame: Every 8 weeks
Every 8 weeks
Patient-oriented Eczema Measure (POEM)
Time Frame: Every 8 weeks
Every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 28, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200917162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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