Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT00233233
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2005-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Data Collection Mode on Self-Report Validity of Asthma Therapy Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2005-10-03', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Concordance between patient's self-reported medication adherence and electronically measured adherence", 'timeFrame': 'Measured at Months 1 through 5'}], 'secondaryOutcomes': [{'measure': 'Impact of mode of assessment on adult self-reports of asthma symptoms, asthma management practices, and quality of life', 'timeFrame': 'Measured at Months 1 through 5'}, {'measure': 'Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome', 'timeFrame': 'Measured at Months 1 through 5'}]}, 'conditionsModule': {'conditions': ['Lung Diseases', 'Asthma']}, 'descriptionModule': {'briefSummary': 'This study will examine how the assessment mode influences the validity of self-reported adherence to asthma therapy. Self-reported adherence to asthma therapy data will be collected using one of three randomized assessment modes (interview, computer, or telephone).', 'detailedDescription': 'BACKGROUND:\n\nSelf-reports are a primary source of behavioral data. Studies have highlighted the variable validity and reliability of self-report measures of health behaviors such as adherence to therapy. Research on self-reports of sensitive information, such as sexual behavior and drug use, suggests that the mode of data collection may enhance validity of self-reports. However, no studies have determined how the mode of data collection influences self-reports when an objective measure of the behavior is available.\n\nDESIGN NARRATIVE:\n\nThe primary aim of this study is to examine the influence of the mode of data collection on the validity of self-reports of inhaled anti-inflammatory medication adherence.\n\nThe key secondary outcomes of the study will attempt to answer the following questions: 1) does the assessment mode influence self-reports of commonly used asthma outcome measures of disease-related symptoms, self-management behaviors, and quality of life?; 2) does the relationship between the assessment mode, the validity of self-reports of adherence, and other measures (i.e., asthma symptoms, self-management behaviors, and quality of life) change over time?; and 3) does the assessment mode interact with baseline personality characteristics and mood to influence the validity of self-reports of adherence and other outcome measures (i.e., asthma symptoms, self-management behaviors, and quality of life)?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of asthma\n* Under a provider's care for asthma\n* Prescribed daily inhaled corticosteroids (by metered dose inhaler \\[MDI\\]) at least 2 times a day\n* Speaks English\n* Otherwise in good general health\n\nExclusion Criteria:\n\nN/A"}, 'identificationModule': {'nctId': 'NCT00233233', 'briefTitle': 'Influence of Data Collection Mode on Self-Report Validity of Asthma Therapy Adherence', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Assessment Mode and Validity of Self-Reports in Adults', 'orgStudyIdInfo': {'id': '325'}, 'secondaryIdInfos': [{'id': 'R01HL064200', 'link': 'https://reporter.nih.gov/quickSearch/R01HL064200', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Standardized Asthma Education Program', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Cynthia Rand, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}