Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-04-09 @ 11:53 PM
Study NCT ID:
NCT01875302
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2013-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2013-06-07', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate that the following PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome)', 'timeFrame': '60 minutes', 'description': 'The primary measures to demonstrate equivalency of electronic to paper PRO instruments are Usability and Cognitive Debriefing.\n\nUsability data is gathered using systematic observation under controlled conditions to determine how well the device may be used by subjects.\n\nQualitative, Content Analysis of Cognitive Debriefing Data The cognitive debriefing data will be content analyzed for subject understanding of the instructions on the device used to deliver the PRO instrument.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD PRO Instraments equivalency'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': "This protocol defines the requirements to demonstrate that the PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All validation studies of the questionnaires were conducted using the original paper versions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD Subjects', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Give their signed written informed consent to participate\n* Current symptoms COPD, as diagnosed by a physician\n* Age 40 - 75 years\n* Able to read and understand English\n\nExclusion Criteria:\n\n• Unwilling to complete the 3 electronic PRO questionnaires or participate in an interview during completion of questionnaires'}, 'identificationModule': {'nctId': 'NCT01875302', 'briefTitle': 'Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions', 'organization': {'class': 'INDUSTRY', 'fullName': 'nSpire Health, Inc.'}, 'officialTitle': 'Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions', 'orgStudyIdInfo': {'id': 'NSH-001'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michelle Vig, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'nSpire Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'nSpire Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}