The Development and Evaluation of an "E-Visit" Program for the Management of Acne

March 14, 2012 updated by: Joseph C. Kvedar, Massachusetts General Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Across the United States, a geographically mal-distributed workforce of Dermatologists exists, a problem that is projected to worsen. Patient access to dermatologic care is threatened. The dermatology workforce shortage has resulted in long wait times for patients, especially new patient visits and acute care cases.

Teledermatology has received much attention as a solution to the preceding problems. Teledermatology can reduce the burden of repeat office visits in chronic conditions by facilitating care from home. In this trial, a model incorporating store-and-forward technology is tested in general clinics while its impact on clinical outcomes, satisfaction, and wait times are studied.

Comparison: After consent, study subjects are assigned a unique study number and randomly assigned to one of two groups:

Group 1- The first group of subjects will have four (4) in-office visits spaced six weeks apart.

Group 2- The second group will have four (4) "e-visits" spaced six weeks apart.

At the end of study (after completion of 5th visit overall) all participants will complete a satisfaction survey.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH Dermatology Associates
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Office Visits
Other: Office visit
Conventional office-based care
Experimental: 2
Evisit
Other: Evisit
Asynchronous,remote care delivery via a secure web platform
Other Names:
  • RelayHealth platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Subject satisfaction
Time Frame: 6 months
6 months
Physician satisfaction
Time Frame: 6 months
6 months
Timing of visits
Time Frame: ongoing
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Joseph C. Kvedar, M.D., Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 29, 2006

First Submitted That Met QC Criteria

December 29, 2006

First Posted (Estimate)

January 1, 2007

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-P-000289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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