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

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00417456

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:

That an "E-Visit" is an effective alternative to in-person clinic care for patients with mild to severe facial acne.
That providers and patients will be satisfied with this model.
That mean wait times for new and return visits will be reduced through the "E-Visit" model.
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:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
1: Active Comparator Office Visits	Other: Office visit Conventional office-based care
2: Experimental Evisit	Other: Evisit Asynchronous,remote care deliverly via a secure web 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

Responsible Party:	Partners Healthcare ( Joseph Kvedar )
Study ID Numbers:	2005-P-000289
Study First Received:	December 29, 2006
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00417456 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Acne
Telemedicine
Dermatology

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies

Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Acneiform Eruptions
Sebaceous Gland Diseases
Acne Vulgaris

ClinicalTrials.gov processed this record on September 11, 2009