The Development and Evaluation of an "E-Visit" Program fo... | NCT00417456

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

NCT00417456

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Mar 16, 2012Estimated

Enrollment

151Actual

Phase

Not Applicable

Conditions

Acne Vulgaris

Interventions

Evisit
Office visit

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 29, 2006

First Submission Date that Met QC Criteria

Dec 29, 2006

First Posted Date

Jan 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2012

Last Update Posted Date

Mar 16, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph C. Kvedar, Director, Center for Connected Health, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

151Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Office Visits	Other: Office visit
2	Experimental	Evisit	Other: Evisit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evisit	Other	Asynchronous,remote care delivery via a secure web platform	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment		6 months

Secondary Outcomes

Measure	Description	Time Frame
Subject satisfaction		6 months
Physician satisfaction		6 months
Timing of visits

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph C. Kvedar, M.D.	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MGH Dermatology Associates		Boston	Massachusetts	02114	United States
Brigham and Women's Hospital Department of Dermatology

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20404229	Derived	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.

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

ID	Term
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration