Evaluation of Clinical Outcomes in an Online Teledermatology Model for the Management of Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Online Teledermatology Care
Conventional in Office Care
Sponsored by
About this trial
This is an interventional health services research trial for Psoriasis focused on measuring Teledermatology, Telemedicine, Psoriasis
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older at time of consent, may be men or women.
- Requiring treatment of psoriasis for medically-indicated reasons.
- Capable of giving informed consent.
- Able to have their skin imaged by themselves or by family members.
Exclusion Criteria:
- Non-English speaking individuals.
- Individuals lacking access to a digital camera and computer with internet connection.
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
Psoriasis Area Severity Index (PASI)
Secondary Outcome Measures
Full Information
NCT ID
NCT00971477
First Posted
September 1, 2009
Last Updated
December 9, 2010
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT00971477
Brief Title
Evaluation of Clinical Outcomes in an Online Teledermatology Model for the Management of Psoriasis
Official Title
Evaluation of Clinical Outcomes in an Online Teledermatology Model for the Management of Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
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 psoriasis. 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 psoriasis 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
Psoriasis
Keywords
Teledermatology, Telemedicine, Psoriasis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (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 a store and forward teledermatology modality.
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
Psoriasis Area Severity Index (PASI)
Time Frame
Every 6-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older at time of consent, may be men or women.
Requiring treatment of psoriasis for medically-indicated reasons.
Capable of giving informed consent.
Able to have their skin imaged by themselves or by family members.
Exclusion Criteria:
Non-English speaking individuals.
Individuals lacking access to a digital camera and computer with internet connection.
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
Learn more about this trial
Evaluation of Clinical Outcomes in an Online Teledermatology Model for the Management of Psoriasis
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