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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph C. Kvedar, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00417456
First received: December 29, 2006
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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.

Condition Intervention
Acne Vulgaris
 Other: Evisit
Other: Office visit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Development and Evaluation of an "E-Visit" Program for the Management of Acne

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subject satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Physician satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Timing of visits [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: RelayHealth platform

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417456

Locations
United States, Massachusetts
MGH Dermatology Associates
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital Department of Dermatology
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Joseph C. Kvedar, M.D. Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joseph C. Kvedar, Director, Center for Connected Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00417456     History of Changes
Other Study ID Numbers: 2005-P-000289
Study First Received: December 29, 2006
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Acne
Telemedicine
Dermatology

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on June 18, 2013