Evaluation of Clinical Outcomes in an Online Teledermatol... | NCT00971477

Studies
Evaluation of Clinical Outcomes in an Online Teledermatology Model for the Management of Psoriasis

NCT00971477

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Dec 13, 2010Estimated

Enrollment

64Actual

Phase

Phase 2

Conditions

Psoriasis

Interventions

Online Teledermatology Care
Conventional in Office Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Sep 1, 2009

First Submission Date that Met QC Criteria

Sep 2, 2009

First Posted Date

Sep 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2010

Last Update Posted Date

Dec 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teledermatology	Experimental	Online Telemedicine Group	Other: Online Teledermatology Care
Usual Care	Active Comparator	Conventional in-office care	Other: Conventional in Office Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Online Teledermatology Care	Other	Patients randomized to the intervention group will have their scheduled follow-up visits online via a store and forward teledermatology modality.

Measure	Description	Time Frame
Psoriasis Area Severity Index (PASI)		Every 6-8 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
April W Armstrong, MD	UC Davis Department of Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Department of Dermatology		Sacramento	California	95816	United States

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003226	Congresses as Topic

Ancestor Terms

ID	Term
D009938	Organizations
D004472	Health Care Economics and Organizations

Browse Leaves

Not provided

Browse Branches

Not provided