Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT00417456
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2006-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Development and Evaluation of an "E-Visit" Program for the Management of Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009819', 'term': 'Office Visits'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2006-12-29', 'studyFirstSubmitQcDate': '2006-12-29', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Subject satisfaction', 'timeFrame': '6 months'}, {'measure': 'Physician satisfaction', 'timeFrame': '6 months'}, {'measure': 'Timing of visits', 'timeFrame': 'ongoing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acne', 'Telemedicine', 'Dermatology'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '20404229', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. That an "E-Visit" is an effective alternative to in-person clinic care for patients with mild to severe facial acne.\n2. That providers and patients will be satisfied with this model.\n3. That mean wait times for new and return visits will be reduced through the "E-Visit" model.\n4. That this prototype for care will improve clinic workflow, offer additional patient access, and allow urgent cases to be seen earlier.', 'detailedDescription': '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.\n\nTeledermatology 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.\n\nComparison: After consent, study subjects are assigned a unique study number and randomly assigned to one of two groups:\n\nGroup 1- The first group of subjects will have four (4) in-office visits spaced six weeks apart.\n\nGroup 2- The second group will have four (4) "e-visits" spaced six weeks apart.\n\nAt the end of study (after completion of 5th visit overall) all participants will complete a satisfaction survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 12 or older\n* Diagnosis of mild to severe facial acne\n* Access to a credit card\n* Access to an Internet connection and a computer\n* Ability to image self\n* MA Blue Cross/ Blue Shield Coverage\n\nExclusion Criteria:\n\n* Non-English speaking individuals\n* Patients taking Accutane for their acne\n* Impaired Physical ability to image self\n* Impaired Cognitive ability'}, 'identificationModule': {'nctId': 'NCT00417456', 'briefTitle': 'The Development and Evaluation of an "E-Visit" Program for the Management of Acne', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'The Development and Evaluation of an "E-Visit" Program for the Management of Acne', 'orgStudyIdInfo': {'id': '2005-P-000289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Office Visits', 'interventionNames': ['Other: Office visit']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Evisit', 'interventionNames': ['Other: Evisit']}], 'interventions': [{'name': 'Evisit', 'type': 'OTHER', 'otherNames': ['RelayHealth platform'], 'description': 'Asynchronous,remote care delivery via a secure web platform', 'armGroupLabels': ['2']}, {'name': 'Office visit', 'type': 'OTHER', 'description': 'Conventional office-based care', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MGH Dermatology Associates', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital Department of Dermatology", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Joseph C. Kvedar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Center for Connected Health', 'investigatorFullName': 'Joseph C. Kvedar', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}