Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 6:28 PM
Study NCT ID:
NCT00941694
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2009-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asthma Self-Management in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'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', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-15', 'studyFirstSubmitDate': '2009-07-17', 'studyFirstSubmitQcDate': '2009-07-17', 'lastUpdatePostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma Quality of Life Questionnaire', 'timeFrame': '3 months, 6 months, 1 year'}], 'secondaryOutcomes': [{'measure': 'Asthma Control Questionnaire', 'timeFrame': '3 months, 6 months, 12 months'}, {'measure': 'Health Care Utilization', 'timeFrame': '3 months, 6 months, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'aged', 'self care'], 'conditions': ['Asthma', 'Aged']}, 'descriptionModule': {'briefSummary': 'Asthma self-management is an effective way to improve the outcomes of patients with asthma. However, to be most effective these interventions should be targeted and designed toward a specific population or group. There is currently no asthma self-management intervention directed towards older adults. The hypothesis is that a 6-session asthma self-management intervention will improve the outcomes of older patients with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:: Age over 65, physician diagnosed asthma, need for daily asthma control medication, access to a telephone.\n\n\\-\n\nExclusion Criteria: Smoking history greater than 40 pack years, current smoker, mental impairment that would preclude participation in the asthma self management program\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00941694', 'briefTitle': 'Asthma Self-Management in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Asthma Self-Management in Older Adults', 'orgStudyIdInfo': {'id': 'N011060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-Management Intervention', 'description': 'Will receive 6 asthma self-management group or individual session over a 7 week period', 'interventionNames': ['Behavioral: Self management intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Group will receive 3 phone calls not related to asthma self management over a 7 week period', 'interventionNames': ['Behavioral: placebo group']}], 'interventions': [{'name': 'Self management intervention', 'type': 'BEHAVIORAL', 'description': 'Intervention arm will receive 6 group or individual sessions over a 7 week period', 'armGroupLabels': ['Self-Management Intervention']}, {'name': 'placebo group', 'type': 'BEHAVIORAL', 'description': '3 phone calls not related to asthma self-management', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Alan P Baptist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alan Baptist', 'investigatorAffiliation': 'University of Michigan'}}}}