NCT00417456

Brief Summary

The purpose of this study is to test the efficacy, timeliness, and user satisfaction of an online "E-Visit" application that uses store-and-forward technology for acne patients requiring dermatologic care for their condition. Hypotheses:

  1. 1.That an "E-Visit" is an effective alternative to in-person clinic care for patients with mild to severe facial acne.
  2. 2.That providers and patients will be satisfied with this model.
  3. 3.That mean wait times for new and return visits will be reduced through the "E-Visit" model.
  4. 4.That this prototype for care will improve clinic workflow, offer additional patient access, and allow urgent cases to be seen earlier.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

October 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

2.2 years

First QC Date

December 29, 2006

Last Update Submit

March 14, 2012

Conditions

Keywords

AcneTelemedicineDermatology

Outcome Measures

Primary Outcomes (1)

  • Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment

    6 months

Secondary Outcomes (3)

  • Subject satisfaction

    6 months

  • Physician satisfaction

    6 months

  • Timing of visits

    ongoing

Study Arms (2)

1

ACTIVE COMPARATOR

Office Visits

Other: Office visit

2

EXPERIMENTAL

Evisit

Other: Evisit

Interventions

EvisitOTHER

Asynchronous,remote care delivery via a secure web platform

Also known as: RelayHealth platform
2

Conventional office-based care

1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 12 or older
  • Diagnosis of mild to severe facial acne
  • Access to a credit card
  • Access to an Internet connection and a computer
  • Ability to image self
  • MA Blue Cross/ Blue Shield Coverage

You may not qualify if:

  • Non-English speaking individuals
  • Patients taking Accutane for their acne
  • Impaired Physical ability to image self
  • Impaired Cognitive ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MGH Dermatology Associates

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital Department of Dermatology

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Watson AJ, Bergman H, Williams CM, Kvedar JC. A randomized trial to evaluate the efficacy of online follow-up visits in the management of acne. Arch Dermatol. 2010 Apr;146(4):406-11. doi: 10.1001/archdermatol.2010.29.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Office Visits

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Joseph C. Kvedar, M.D.

    Massachusetts General Hospital

    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
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Connected Health

Study Record Dates

First Submitted

December 29, 2006

First Posted

January 1, 2007

Study Start

October 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations