Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-03-05 @ 11:59 PM
Study NCT ID:
NCT00488293
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2007-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Teledermatology on Health Services Outcomes in the Department of Veterans Affairs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.whited@va.gov', 'phone': '919-286-6926', 'title': 'John D. Whited, MD, MHS', 'organization': 'Department of Veterans Affairs'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set', 'otherNumAtRisk': 196, 'otherNumAffected': 1, 'seriousNumAtRisk': 196, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult', 'otherNumAtRisk': 196, 'otherNumAffected': 2, 'seriousNumAtRisk': 196, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash from Sunscreen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection at Biopsy Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death Unrelated to Study Participation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'OG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.0', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '21.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 9', 'description': 'Skindex-16 Change Scores. 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A change score of 10 points is considered clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline to Month 9 Skindex-16 change scores - Composite Score.'}, {'type': 'SECONDARY', 'title': 'Clinical Course Rating Between Baseline and Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'OG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}], 'classes': [{'title': 'Resolved', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Unchanged - Not Clinically Relevant', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Unchanged - Clinically Relevant', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 9', 'description': 'Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical course rating between baseline and month 9'}, {'type': 'PRIMARY', 'title': 'Skindex-16 Change Scores Baseline to Month 3 - Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'OG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 3', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline to Month 3 Skindex-16 change scores - Composite Score'}, {'type': 'PRIMARY', 'title': 'Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'OG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.3', 'spread': '30.6', 'groupId': 'OG000'}, {'value': '-14.4', 'spread': '28.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 9', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline to Month 9 Skindex-16 change scores - Symptoms Score'}, {'type': 'PRIMARY', 'title': 'Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'OG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.7', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '22.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 3', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline to Month 3 Skindex-16 change score - Symptoms Score'}, {'type': 'PRIMARY', 'title': 'Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'OG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.7', 'spread': '30.7', 'groupId': 'OG000'}, {'value': '-18.1', 'spread': '25.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 9', 'description': 'Skindex-16 Change Scores. 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A change score of 10 points is considered clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline to Month 3 Skindex-16 change scores - Emotions Score'}, {'type': 'PRIMARY', 'title': 'Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'OG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.0', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '22.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 9', 'description': 'Skindex-16 Change Scores. 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Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline to Month 3 Skindex-16 change scores - Functioning Scores'}, {'type': 'SECONDARY', 'title': 'Clinical Course Rating Between Baseline and First Clinic Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'OG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}], 'classes': [{'title': 'Resolved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Unchanged - Not Clinically Relevant', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Unchanged - Clinically Relevant', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to First Clinic Visit', 'description': 'Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical course rating between baseline and first clinic visit, if a visit occurred. Timeframe varied and only applied if a first clinic visit occurred.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'FG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Misrandomization/Other Unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment occurred between 2008 and 2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Teledermatology Referrals', 'description': 'Store and forward teledermatology consult process\n\nStore and forward teledermatology: Standard electronic consult, standardized history, and image set'}, {'id': 'BG001', 'title': 'Conventional Referrals', 'description': 'Conventional consult process\n\nConventional consult process: Standard electronic consult'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One patient assigned to teledermatology was misrandomized and not included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2007-06-18', 'resultsFirstSubmitDate': '2014-11-03', 'studyFirstSubmitQcDate': '2007-06-19', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-05', 'studyFirstPostDateStruct': {'date': '2007-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score', 'timeFrame': 'Baseline to Month 9', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.'}, {'measure': 'Skindex-16 Change Scores Baseline to Month 3 - Composite Score', 'timeFrame': 'Baseline to Month 3', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.'}, {'measure': 'Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score', 'timeFrame': 'Baseline to Month 9', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.'}, {'measure': 'Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score', 'timeFrame': 'Baseline to Month 3', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.'}, {'measure': 'Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score', 'timeFrame': 'Baseline to Month 9', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.'}, {'measure': 'Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score', 'timeFrame': 'Baseline to Month 3', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.'}, {'measure': 'Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores', 'timeFrame': 'Baseline to Month 9', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.'}, {'measure': 'Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score', 'timeFrame': 'Baseline to Month 3', 'description': 'Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.'}], 'secondaryOutcomes': [{'measure': 'Clinical Course Rating Between Baseline and Month 9', 'timeFrame': 'Baseline to Month 9', 'description': 'Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.'}, {'measure': 'Clinical Course Rating Between Baseline and First Clinic Visit', 'timeFrame': 'Baseline to First Clinic Visit', 'description': 'Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Telemedicine', 'Skin diseases', 'Dermatology', 'Quality of life', 'Economics'], 'conditions': ['Skin Diseases', 'Telemedicine', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '23426111', 'type': 'BACKGROUND', 'citation': 'Whited JD, Warshaw EM, Edison KE, Kapur K, Thottapurathu L, Raju S, Cook B, Engasser H, Pullen S, Parks P, Sindowski T, Motyka D, Brown R, Moritz TE, Datta SK, Chren MM, Marty L, Reda DJ. Effect of store and forward teledermatology on quality of life: a randomized controlled trial. JAMA Dermatol. 2013 May;149(5):584-91. doi: 10.1001/2013.jamadermatol.380.'}, {'pmid': '23666440', 'type': 'RESULT', 'citation': 'Whited JD, Warshaw EM, Kapur K, Edison KE, Thottapurathu L, Raju S, Cook B, Engasser H, Pullen S, Moritz TE, Datta SK, Marty L, Foman NA, Suwattee P, Ward DS, Reda DJ. Clinical course outcomes for store and forward teledermatology versus conventional consultation: a randomized trial. J Telemed Telecare. 2013 Jun;19(4):197-204. doi: 10.1177/1357633x13487116. Epub 2013 May 23.'}, {'pmid': '26375589', 'type': 'DERIVED', 'citation': 'Datta SK, Warshaw EM, Edison KE, Kapur K, Thottapurathu L, Moritz TE, Reda DJ, Whited JD. Cost and Utility Analysis of a Store-and-Forward Teledermatology Referral System: A Randomized Clinical Trial. JAMA Dermatol. 2015 Dec 1;151(12):1323-1329. doi: 10.1001/jamadermatol.2015.2362.'}]}, 'descriptionModule': {'briefSummary': 'This study compares store and forward teledermatology with the conventional clinic-based consult process. Our primary objective is to determine whether the mean change in quality of life, as rated by the subscale scores and composite score on the Skindex-16 differs between the store and forward and conventional care modalities.', 'detailedDescription': "Anticipated Impact on Veterans' Healthcare - Teledermatology has the potential to have a significant impact on veterans' healthcare. There is an unmet demand for Dermatology services distributed throughout a nation-wide patient base. Decentralization of care through the expansion of Community Based Outpatient Centers (CBOCs) adds to the demand for these services. Dermatologic care typically resides only at the largest medical centers within a Veterans Integrated Service Network (VISN). Teledermatology is one means of meeting the demand for Dermatology services by delivering dermatologic care to those sites that are geographically removed from the Dermatology Consult Service.\n\nProject Background - For the majority of ambulatory skin conditions encountered in Primary Care and Dermatology Clinics the impact those conditions have on patients' quality of life is of principal importance. Commonly encountered skin diseases frequently result in discomfort or pain, pruritis, emotional concerns, embarrassment, anxiety, and interfere with activities of daily living, work activities, or interpersonal relations. To date, no data exist that compares quality of life outcomes - the fundamental metric to assess in an ambulatory dermatology population - between patients undergoing store and forward teledermatology consultations with patients managed by the conventional consult processes. Existing data does indicate that teledermatology is a reliable and accurate method of diagnosing skin disease.\n\nResearch Objectives - The purpose of this study was to compare store and forward teledermatology with a conventional clinic-based dermatology consultation process. Our primary objective was to determine whether the mean change in patient quality of life, as rated by the composite score and subscale scores of a skin-specific quality of life index (Skindex-16), differed between the time of randomization and 9 months for patients evaluated by store and forward teledermatology compared to conventional consult methods. Secondary objectives included (a) assessing quality of life between time of randomization and 3 months, (b) assessing time to initial definitive evaluation for patients using each modality, (c) evaluating clinical course using serial digital imaging, (d) comparing the costs and cost-effectiveness of store and forward teledermatology with conventional consult methods.\n\nProject Methods - The study was a parallel-group, superiority, randomized clinical trial that compared store and forward teledermatology with a conventional clinic-based consult process. Patients were randomized using a simple randomization scheme stratified by site to one of the two consult modalities. Eligible patients included those being referred from the remote sites of primary care to the medical center-based sites of dermatology services. Skindex-16 was administered at baseline, 3 months, and 9 months. Time to initial definitive evaluation, calculated based on the need for and timing of a clinic-based visit was measured for both groups. Using digital images, clinical course was assessed on a 5 point scale by an expert panel of three dermatologists. Categories included resolved, improved, unchanged not clinically relevant, unchanged clinically relevant, and worse. Health care utilities were measured using time trade-off data and the Health Utilities Index Mark 2 (HUI2). We compared the costs of teledermatology with conventional consult methods by estimating the average cost per patient over the 9 month study period. Effectiveness was assessed using health care utilities and time to initial definitive evaluation. Costs were estimated from the VA perspective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a single non-emergent skin condition being referred to a VA Dermatology Clinic\n* Must be a veteran at the study site\n\nExclusion Criteria:\n\n* Full body examination requested\n* Unable to read or speak English\n* Emergent skin condition\n* Pending dermatology appointment within 9 months\n* Previous enrollment in the study\n* Impending move from the area'}, 'identificationModule': {'nctId': 'NCT00488293', 'briefTitle': 'Impact of Teledermatology on Health Services Outcomes in the Department of Veterans Affairs', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Impact of Teledermatology on Health Services Outcomes in the VA', 'orgStudyIdInfo': {'id': 'IIR 05-278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Store and forward teledermatology consult process', 'interventionNames': ['Procedure: Store and forward teledermatology']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 2', 'description': 'Conventional consult process'}], 'interventions': [{'name': 'Store and forward teledermatology', 'type': 'PROCEDURE', 'otherNames': ['Teledermatology'], 'description': 'Standard electronic consult, standardized history, and image set', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Health Care System, Minneapolis, MN', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65201-5297', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Harry S. Truman Memorial, Columbia, MO', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'John D. Whited, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harry S. Truman Memorial, Columbia, MO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}