Clinical trial NCT00417456: The Development and Evaluation of an "E-Visit" Program for the Management of Acne
Official title: The Development and Evaluation of an "E-Visit" Program for the Management of Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: Acne
Telemedicine
Dermatology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-01-01
Enrollment: 151
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

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 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

Primary outcomes:
measure: Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment
timeFrame: 6 months
Secondary outcomes:
measure: Subject satisfaction
timeFrame: 6 months
measure: Physician satisfaction
timeFrame: 6 months
measure: Timing of visits
timeFrame: ongoing
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Dermatology Associates
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital Department of Dermatology
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph C. Kvedar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.