The Development and Evaluation of an "E-Visit" Program for the Management of Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Evisit
Office visit
Sponsored by
About this trial
This is an interventional health services research trial for Acne Vulgaris focused on measuring Acne, Telemedicine, Dermatology
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
Sites / Locations
- MGH Dermatology Associates
- Brigham and Women's Hospital Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Office Visits
Evisit
Outcomes
Primary Outcome Measures
Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment
Secondary Outcome Measures
Subject satisfaction
Physician satisfaction
Timing of visits
Full Information
NCT ID
NCT00417456
First Posted
December 29, 2006
Last Updated
March 14, 2012
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00417456
Brief Title
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne, Telemedicine, Dermatology
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Office Visits
Arm Title
2
Arm Type
Experimental
Arm Description
Evisit
Intervention Type
Other
Intervention Name(s)
Evisit
Other Intervention Name(s)
RelayHealth platform
Intervention Description
Asynchronous,remote care delivery via a secure web platform
Intervention Type
Other
Intervention Name(s)
Office visit
Intervention Description
Conventional office-based care
Primary Outcome Measure Information:
Title
Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Subject satisfaction
Time Frame
6 months
Title
Physician satisfaction
Time Frame
6 months
Title
Timing of visits
Time Frame
ongoing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph C. Kvedar, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Dermatology Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital Department of Dermatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20404229
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.
Results Reference
derived
Learn more about this trial
The Development and Evaluation of an "E-Visit" Program for the Management of Acne
We'll reach out to this number within 24 hrs