Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT04017559
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-10', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inhaled Antibiotic collection percentage', 'timeFrame': '6 months preceding intervention compared to end of 6 month intervention period', 'description': 'Change in adherence to Inhaled Antibiotic measured by collection from pharmacy in 6 months before intervention and at end of intervention'}], 'secondaryOutcomes': [{'measure': 'Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)', 'timeFrame': '6 months', 'description': 'Change in ppFEV1 from start of study to end of study (6 months)'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '6 months', 'description': 'Change in BMI from start of study to end of study (6 months)'}, {'measure': 'Need for additional Intra-venous or oral antibiotics', 'timeFrame': '6 months', 'description': 'change in additional antibiotic days from 6 months preceding the intervention to end of intervention period'}, {'measure': 'Treatment quality and satisfaction (TQSM)', 'timeFrame': '6 months', 'description': 'Change in TQSM from start to end of intervention period'}, {'measure': 'Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)', 'timeFrame': '6 months', 'description': 'Change in MMAS-8 from start to end of intervention period'}, {'measure': 'Density of Pseudomonas growth in sputum', 'timeFrame': '6 months', 'description': 'Change in density of pseudomonas growth from start to end of intervention period'}, {'measure': 'Quality of life measured by CFQ-R', 'timeFrame': '6 months', 'description': 'Change in quality of life from start to end of intervention period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Adherence to treatment is a major challenge in cystic fibrosis (CF). Motivational Interviewing (MI) is increasingly used to address this, but its effectiveness is unknown. We investigated the clinical impact of an MI intervention, delivered by a specifically trained pharmacist, on adherence to inhaled antibiotics (IA).', 'detailedDescription': 'Adherence to treatment is a major challenge in cystic fibrosis (CF). Motivational Interviewing (MI) is increasingly used to address this, but its effectiveness is unknown. We investigated the clinical impact of an MI intervention, delivered by a specifically trained pharmacist, on adherence to inhaled antibiotics (IA).\n\nAdults with CF were recruited through the Regional CF Centre. A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months. Demographics, ppFEV1, BMI, adherence (IA collection rates) and additional antibiotic use were collected during the study and for 6 months prior. Treatment Quality and Satisfaction (TQSM), self-reported adherence (Moriskey Medication Adherence Scale-8 (MMAS-8)), Quality Of Life (CF Questionnaire-Revised (CFQ-R)) and sputum Pseudomonas aeruginosa (Pa) density were assessed at each study visit. Statistical analysis compared outcomes pre and post-intervention and variation during the intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients with a documented diagnosis of CF aged ≥18 years on the date of informed consent\n2. Known chronic infection with Pa, as defined by the Leeds criteria\n3. Has been prescribed inhaled colomycin and/or tobramycin and/or aztreonam for a minimum of 3 months prior to study enrolment\n4. Able to provide written informed consent\n5. Able to understand and comply with protocol requirements and instructions\n6. Has been identified by the physician during routine appointments as having difficulties with adherence to their inhaled therapies\n\nExclusion Criteria:\n\n1. Patients that do not expectorate sputum spontaneously\n2. Inability to complete questionnaires'}, 'identificationModule': {'nctId': 'NCT04017559', 'briefTitle': 'Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Belfast Health and Social Care Trust'}, 'officialTitle': 'Assessing the Clinical Impact of Motivational Interviewing on Inhaled Antibiotic Adherence in Cystic Fibrosis', 'orgStudyIdInfo': {'id': '14074DD-AS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention cohort', 'description': 'All participants were entered into the intervention cohort to receive the Motivational Interviewing intervention', 'interventionNames': ['Behavioral: Motivational Interviewing']}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.', 'armGroupLabels': ['Intervention cohort']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Belfast Health and Social Care Trust', 'class': 'OTHER'}, 'collaborators': [{'name': "Queen's University, Belfast", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}