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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Teledermatology Care
Conventional in Office Care
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atopic Dermatitis focused on measuring Teledermatology, Telemedicine, Atopic Dermatitis

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UC Davis Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teledermatology

Usual Care

Arm Description

Online Telemedicine Group

Conventional in-office care

Outcomes

Primary Outcome Measures

Eczema Area and Severity Index (EASI)
Patient-oriented Eczema Measure (POEM)

Secondary Outcome Measures

Full Information

First Posted
September 25, 2009
Last Updated
May 24, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00985894
Brief Title
Comparison Between Asynchronous Online Care Model With Usual In Office Care for the Management of Atopic Dermatitis
Official Title
Comparison Between Asynchronous Online Care Model for the Management of Atopic Dermatitis With That of Face-to-Face, Office Visits
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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: Compared to in-person visits, the online care model will result in similar clinical improvement in atopic dermatitis disease severity. Compared to in-person visits, the online care model will result in similar improvements in quality of life. Providers and subjects in the online group will achieve a similar level of overall satisfaction as those in the in-person group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Teledermatology, Telemedicine, Atopic Dermatitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teledermatology
Arm Type
Experimental
Arm Description
Online Telemedicine Group
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Conventional in-office care
Intervention Type
Other
Intervention Name(s)
Online Teledermatology Care
Other Intervention Name(s)
Health care service modality
Intervention Description
Patients randomized to the intervention group will have their scheduled follow-up visits online via store and forward teledermatology.
Intervention Type
Other
Intervention Name(s)
Conventional in Office Care
Other Intervention Name(s)
Health care service modality
Intervention Description
Patients randomized to the control group will have their scheduled follow-up visits via conventional in office care.
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI)
Time Frame
Every 8 weeks
Title
Patient-oriented Eczema Measure (POEM)
Time Frame
Every 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
April W Armstrong, MD
Organizational Affiliation
UC Davis Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25338198
Citation
Armstrong AW, Johnson MA, Lin S, Maverakis E, Fazel N, Liu FT. Patient-centered, direct-access online care for management of atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2015 Feb;151(2):154-60. doi: 10.1001/jamadermatol.2014.2299.
Results Reference
derived

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

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