Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02203266
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2014-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2014-07-27', 'studyFirstSubmitQcDate': '2014-07-27', 'lastUpdatePostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of adherence', 'timeFrame': '2 months and 6 months', 'description': 'The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.'}], 'secondaryOutcomes': [{'measure': 'Rescue inhaled medication use', 'timeFrame': 'Six months'}, {'measure': 'Rescue antibiotic and/or steroid medication use', 'timeFrame': '6 months'}, {'measure': 'Quality of life', 'timeFrame': '2 months and 6 months'}, {'measure': 'Adherence in the time domain', 'timeFrame': 'Two months and six months'}, {'measure': 'Technique adherence', 'timeFrame': 'Two months and six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medication Adherence', 'Patient Compliance'], 'conditions': ['Asthma', 'Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '27142873', 'type': 'DERIVED', 'citation': "O'Dwyer SM, MacHale E, Sulaiman I, Holmes M, Hughes C, D'Arcy S, Rapcan V, Taylor T, Boland F, Bosnic-Anticevich S, Reilly RB, Ryder SA, Costello RW. The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA(R), in a community pharmacy setting: study protocol for a randomised controlled trial. Trials. 2016 May 4;17(1):226. doi: 10.1186/s13063-016-1362-9."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:\n\n* Improved compliance with prescribed inhaler use\n* Improved technique of inhaler use\n* A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage.\n* An improvement in patient quality of life scores'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 18 years old or above\n* Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed\n* Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits.\n* Able and willing to take inhaled medication.\n* Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler.\n* Have a history of regular attendance in the pharmacy in which they are recruited which will be demonstrated by the subject having collected three prescriptions for any medication in that pharmacy in the six months preceeding their recruitment to the study.\n\nExclusion Criteria:\n\n* Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months'}, 'identificationModule': {'nctId': 'NCT02203266', 'briefTitle': 'Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting', 'organization': {'class': 'OTHER', 'fullName': 'Beaumont Hospital'}, 'officialTitle': 'A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting', 'orgStudyIdInfo': {'id': 'RC004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feedback', 'description': "Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.", 'interventionNames': ['Device: Feedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Demonstration', 'description': 'Current best practice - inhaler technique education', 'interventionNames': ['Behavioral: Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual care in the community pharmacy setting'}], 'interventions': [{'name': 'Feedback', 'type': 'DEVICE', 'otherNames': ['INCA Device'], 'description': "Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.", 'armGroupLabels': ['Feedback']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': "Feedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months.", 'armGroupLabels': ['Demonstration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'country': 'Ireland', 'facility': 'Boots Retail (Ireland) Limited', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Richard Costello, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal College of Surgeons in Ireland, Clinical Research Centre, Beaumont Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beaumont Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Richard Costello', 'investigatorFullName': 'Professor Richard Costello', 'investigatorAffiliation': 'Beaumont Hospital'}}}}