Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-18 @ 1:38 AM
Study NCT ID:
NCT01964469
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2013-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consumer Access to Personal Health Information for Asthma Self-Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-04-13', 'releaseDate': '2020-03-27'}, {'resetDate': '2020-05-15', 'releaseDate': '2020-04-22'}], 'estimatedResultsFirstSubmitDate': '2020-03-27'}}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-15', 'studyFirstSubmitDate': '2013-01-21', 'studyFirstSubmitQcDate': '2013-10-14', 'lastUpdatePostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health Outcome - Quality', 'timeFrame': '1 year', 'description': 'Improvements in symptom profile greater than conventional best practice.'}, {'measure': 'Health Outcome - Quality of Life', 'timeFrame': '6 months', 'description': 'Per protocol evaluation of the primary outcome, quality of life. It is anticipated that some subjects randomized to the intervention arm will not use the smartphone application. We seek to evaluate the primary outcome in those subjects who were adherent to the application compared to control subjects.'}], 'primaryOutcomes': [{'measure': 'Health Outcome - Quality of Life', 'timeFrame': '6 months', 'description': 'Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice.'}], 'secondaryOutcomes': [{'measure': 'Quality - Health Care Utilization', 'timeFrame': '1 year', 'description': 'Appropriateness of Care - Individuals with asthma who use the intervention will experience a decrease in the number of unplanned health system encounters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '30688654', 'type': 'DERIVED', 'citation': 'Morita PP, Yeung MS, Ferrone M, Taite AK, Madeley C, Stevens Lavigne A, To T, Lougheed MD, Gupta S, Day AG, Cafazzo JA, Licskai C. A Patient-Centered Mobile Health System That Supports Asthma Self-Management (breathe): Design, Development, and Utilization. JMIR Mhealth Uhealth. 2019 Jan 28;7(1):e10956. doi: 10.2196/10956.'}]}, 'descriptionModule': {'briefSummary': 'This study is to compare Smart phone mobile device and/or web based application asthma action plan to the standard of care paper based asthma action plan within an asthma program. The Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice', 'detailedDescription': 'This study is a multi-centre, randomized controlled trial comparing a web-based (Smart phone mobile device, tablet and/or personal computer PC) asthma action plan application to best practice/usual care within an asthma program. A third external comparator arm will compare participants to all patients with asthma in Ontario using data obtained from the Ontario Asthma Surveillance Information System (OASIS) cohort, created from administrative data sets within the Institute for Clinical Evaluative Sciences (ICES). Subjects will be randomly assigned in blocks of four, stratified by site to, in a ratio of 1:1 intervention or control arms. The study will enrol approximately 400 patients in total at all study sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asthma\n* Age 18 of age or older\n* Familiar with web technology\n* Provide consent\n* Understand/read/write English\n\nExclusion Criteria:\n\n\\- Indication of other chronic lung diseases in the opinion of the physician that would impact their ability to participate in the trial or affect quality of life (Cystic Fibrosis, Chronic Obstructive Pulmonary Disease, Bronchiectasis)'}, 'identificationModule': {'nctId': 'NCT01964469', 'acronym': 'ASMA', 'briefTitle': 'Consumer Access to Personal Health Information for Asthma Self-Management', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)', 'orgStudyIdInfo': {'id': '00000940'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Written self-management action plan', 'description': 'Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review.', 'interventionNames': ['Behavioral: mobile & web-based action plan']}, {'type': 'EXPERIMENTAL', 'label': 'mobile & web based action plan', 'description': 'Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application.', 'interventionNames': ['Behavioral: mobile & web-based action plan']}, {'type': 'NO_INTERVENTION', 'label': 'Administrative data set', 'description': 'Health services use will be evaluated comparatively against our intervention population and our control and we will include health services utilization data from one year prior randomization.'}], 'interventions': [{'name': 'mobile & web-based action plan', 'type': 'BEHAVIORAL', 'description': 'Evidence-based best practice primary care asthma program including asthma self-management education replacing the written self-management action plan with the Breathe mobile health and web-based application', 'armGroupLabels': ['Written self-management action plan', 'mobile & web based action plan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amherstburg', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Amherstburg FHT', 'geoPoint': {'lat': 42.10009, 'lon': -83.09985}}, {'city': 'Chatham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Chatham-Kent FHT', 'geoPoint': {'lat': 42.41224, 'lon': -82.18494}}, {'city': 'Harrow', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Harrow FHT', 'geoPoint': {'lat': 42.03339, 'lon': -82.91654}}, {'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston Hospital Asthma Clinic', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N8H 1N8', 'city': 'Leamington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Leamington FHT', 'geoPoint': {'lat': 42.05009, 'lon': -82.59981}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Hospital Asthma Clinic", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Sault Ste. Marie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sault St. Marie Group Health Centre', 'geoPoint': {'lat': 46.51677, 'lon': -84.33325}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor FHT', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'overallOfficials': [{'name': 'Christopher Licskai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lawson Health Research Institution'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Lung Association', 'class': 'OTHER'}, {'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}, {'name': 'TELUS', 'class': 'UNKNOWN'}, {'name': 'Canada Health Infoway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, University of Western Ontario', 'investigatorFullName': 'Chris Licskai', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-03-27', 'type': 'RELEASE'}, {'date': '2020-04-13', 'type': 'RESET'}, {'date': '2020-04-22', 'type': 'RELEASE'}, {'date': '2020-05-15', 'type': 'RESET'}], 'unpostedResponsibleParty': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}