Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT02046759
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2014-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010353', 'term': 'Patient Education as Topic'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-24', 'studyFirstSubmitDate': '2014-01-24', 'studyFirstSubmitQcDate': '2014-01-24', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of Inhalation Technique', 'timeFrame': 'at baseline and after 2 months of therapy'}, {'measure': 'Patient Adherence to Therapy', 'timeFrame': '2 months of therapy'}], 'primaryOutcomes': [{'measure': 'Asthma Control Questionnaire', 'timeFrame': 'at baseline & after 2 months of therapy'}], 'secondaryOutcomes': [{'measure': 'Forced Expiratory Volume in 1 second (FEV1%)', 'timeFrame': 'at baseline & after 2 months of therapy'}, {'measure': 'Rescue Medication SABA (number of puffs used most days)', 'timeFrame': 'at baseline & after 2 months of therapy'}, {'measure': 'Inhaled Corticosteroid Use (number of puffs used/day)', 'timeFrame': 'at baseline & after 2 months of therapy'}, {'measure': 'Number of courses of systemic steroid used', 'timeFrame': 'During 2 months of therapy'}, {'measure': 'Number of ER visits/ Hospitalization', 'timeFrame': 'During 2 months of therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effect of asthma care by clinical pharmacist intervention versus routine care on asthma control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with clinical diagnosis of bronchial asthma\n* responsible for administering their own asthma medications.\n\nExclusion Criteria:\n\n* patients who were not responsible for administering their own asthma medications.\n* patients with cognitive defects, other pulmonary disease e.g. Chronic Obstructive Pulmonary Disease (COPD), experiencing illness with asthma-like symptoms e.g. Congestive Heart Failure, evidence of fixed airway obstruction\n* patients unavailable for 2-month follow-up.\n* patients who did not provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT02046759', 'briefTitle': 'A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma', 'orgStudyIdInfo': {'id': 'Asthma-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmacist-Intervention', 'interventionNames': ['Other: Pharmacist- Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Care', 'interventionNames': ['Other: Routine Care']}], 'interventions': [{'name': 'Pharmacist- Intervention', 'type': 'OTHER', 'otherNames': ['Patient Education', 'Asthma Action Plan', 'Shared Decision Making'], 'description': 'Patients received additional education on basic facts about asthma, role of medications, the difference between long-term control medications and quick-relief medications, as well as patient skills in the first visit then reinforcement every two weeks.. The importance of proper inhaler technique, avoidance of asthma triggers and self-monitoring of asthma were also highlighted. Visual aids, physical demonstration as well as written information resources were supplied. Asthma care plans were tailored to patient needs and preferences. Patients were informed how to detect early signs of worsening asthma, when and how to seek medical care as appropriate.', 'armGroupLabels': ['Pharmacist-Intervention']}, {'name': 'Routine Care', 'type': 'OTHER', 'description': 'Patients received usual care delivered by physician without pharmacist intervention. Patients were prescribed asthma medication with summarized basic information on asthma and medication use. Follow-up visits were not planned on consistent basis, but rather individually according to the disease status. No asthma action plans were provided.', 'armGroupLabels': ['Routine Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Rana R Farrag', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ahram Canadian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'Rana Rasheed Ibrahim Farrag', 'investigatorAffiliation': 'Ain Shams University'}}}}