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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417456
• Other study ID #: 2005-P-000289
• Status: Completed
• Phase: N/A
• First received: December 29, 2006
• Last updated: March 14, 2012
• Start date: October 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• Evisit
Asynchronous,remote care delivery via a secure web platform
• Office visit
Conventional office-based care

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital Department of Dermatology	Boston	Massachusetts
United States	MGH Dermatology Associates	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment		6 months	Yes
Secondary	Subject satisfaction		6 months	No
Secondary	Physician satisfaction		6 months	No
Secondary	Timing of visits		ongoing	No