Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-03-17 @ 11:40 PM
Study NCT ID:
NCT02283892
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2014-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Complaints Checklist Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057189', 'term': 'Checklist'}, {'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2014-11-03', 'studyFirstSubmitQcDate': '2014-11-03', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need to visit the emergency department or acute evaluation outpatient clinic', 'timeFrame': '1 month'}, {'measure': 'Complete blood count ordered in the index evaluation', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Number of diagnostic tests ordered in the index evaluation', 'timeFrame': '1 month'}, {'measure': 'Hospital admission', 'timeFrame': '1 month'}, {'measure': 'Antibiotics prescription', 'timeFrame': '1 month', 'description': 'Frequency and type of antibiotic prescribed in each study arm'}, {'measure': 'Major events', 'timeFrame': '1 month', 'description': 'Composite endpoint: revisit to emergency department OR hospital admission OR death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['respiratory complaints', 'dyspnea', 'cough', 'checklist'], 'conditions': ['Dyspnea', 'Cough']}, 'descriptionModule': {'briefSummary': 'This is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist.', 'detailedDescription': 'This is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist.\n\nStudy setting: emergency department related acute evaluation outpatient clinic\n\nInclusion criteria: 18 years of age or older; patients presenting to the ED reporting cough or dyspnea;\n\nExclusion criteria: acute respiratory failure; SpO2 \\< 92%; any signs of hemodynamic or respiratory instability; possible concurrent diagnosis requiring immediate assessment (e.g..: acute coronary syndrome or stroke; )\n\nPrimary outcome: need of reassessment in the ED or hospitalization within 1 month of index evaluation (intervention).\n\nSecondary outcomes: number of complete blood counts ordered in the index evaluation; number of other diagnostic tests ordered in the index evaluation;\n\nRandomization: block 1:1; stratified by gender and age (\\>50 years old).\n\nMasking will be appllied to: patients; outcome assessors; data analysts;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '18 years of age or older; patients presenting to the ED reporting cough or dyspnea; legally capable.\n\nExclusion criteria: acute respiratory failure; SpO2 \\< 92%; any signs of hemodynamic or respiratory instability; possible concurrent diagnosis requiring immediate assessment (e.g..: acute coronary syndrome or stroke; )'}, 'identificationModule': {'nctId': 'NCT02283892', 'acronym': 'RCC', 'briefTitle': 'Respiratory Complaints Checklist Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Randomized Clinical Trial of the Impact of a Respiratory Complaints Assessment Checklist on Resources Utilization and Clinical Outcomes in an Acute Evaluation Outpatient Clinic', 'orgStudyIdInfo': {'id': '14-0198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Checklist', 'description': '2 checklists available for consultation by the attending physician: (1) dyspnea evaluation checklist and (2) cough evaluation checklist. The checklists are available on computers and mobile devices (smartphone, PDA or tablet computer).', 'interventionNames': ['Other: Checklist']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional assessment', 'description': 'Evaluation of patients reporting dyspnea or cough made by the attending physician, without the use of the checklists for dyspnea or cough evaluation.', 'interventionNames': ['Other: Conventional evaluation']}], 'interventions': [{'name': 'Checklist', 'type': 'OTHER', 'otherNames': ['Clinical protocol'], 'description': '3 page checklist with suggestions of possible diagnosis according to clinical presentation of patients presenting with dyspnea or cough; also suggests diagnostic tests that are likely to be useful in each situation.', 'armGroupLabels': ['Checklist']}, {'name': 'Conventional evaluation', 'type': 'OTHER', 'otherNames': ['Unaided physician evaluation'], 'description': 'Physician evaluation without the use of checklists', 'armGroupLabels': ['Conventional assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Internal Medicine Department Physician', 'investigatorFullName': 'André Luis Ferreira Azeredo-Da-Silva', 'investigatorAffiliation': 'Hospital de Clinicas de Porto Alegre'}}}}