NCT00985894

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:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

September 25, 2009

Last Update Submit

May 24, 2017

Conditions

Atopic Dermatitis

Keywords

TeledermatologyTelemedicineAtopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • Eczema Area and Severity Index (EASI)

    Every 8 weeks

  • Patient-oriented Eczema Measure (POEM)

    Every 8 weeks

Study Arms (2)

Teledermatology

EXPERIMENTAL

Online Telemedicine Group

Other: Online Teledermatology Care

Usual Care

ACTIVE COMPARATOR

Conventional in-office care

Other: Conventional in Office Care

Interventions

Online Teledermatology CareOTHER

Patients randomized to the intervention group will have their scheduled follow-up visits online via store and forward teledermatology.

Also known as: Health care service modality
Teledermatology
Conventional in Office CareOTHER

Patients randomized to the control group will have their scheduled follow-up visits via conventional in office care.

Also known as: Health care service modality
Usual Care

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Non English speaking patients.
  • Patients requiring systemic treatment (e.g., cyclosporine, phototherapy).
  • Patients requiring close laboratory monitoring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (1)

  • 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.

    PMID: 25338198DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • April W Armstrong, MD

    UC Davis Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 29, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)