Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-04 @ 2:56 AM
Study NCT ID:
NCT03337958
Status:
UNKNOWN
Last Update Posted:
2018-07-12
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Education With Inhalers in Patients With COPD Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory parameters', 'timeFrame': 'baseline, 12 months', 'description': 'Changes from baseline to postintervention in respiratory parameters using a spirometer. The most important respiratory parameters evaluated is forced expiratory volume in the first second (FEV1)'}], 'secondaryOutcomes': [{'measure': 'Knowledge of the disease', 'timeFrame': 'Baseline, 12 months', 'description': 'Evaluated at baseline by EPOC-Q'}, {'measure': 'Cognitive Level', 'timeFrame': 'Baseline', 'description': 'Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).'}, {'measure': 'Functional independence', 'timeFrame': 'Baseline', 'description': 'Functional independence was assessed using the Functional Independence Scale (FIM).'}, {'measure': 'Anxiety-depression level', 'timeFrame': 'Baseline', 'description': 'Changes from baseline to postintervention in anxiety and depression measured with the Hospital Anxiety and Depression Scale. Patients are going to complete this questionnaire composed of statements relevant to either generalized anxiety or depression.'}, {'measure': 'Adhesion to inhalers', 'timeFrame': 'Baseline', 'description': 'Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).'}, {'measure': 'Dyspnea level', 'timeFrame': 'baseline, 12 months', 'description': 'Perceived perception of dyspnea was collected through the Modified Borg Scale.'}, {'measure': 'Physical fitness', 'timeFrame': 'baseline, 12 months', 'description': "Physical fitness was assessed by performing the five-times-sit-to-stand test. It consists of getting up and sitting five times in a row without a support. The time period in which the exercise is performed is the patient's score with a maximum of 60 seconds."}, {'measure': 'Technique of the inhaler', 'timeFrame': 'baseline, 12 months', 'description': 'The evaluation of the technique of the inhalers was carried out by means of a checklist composed of 5 items. Checked those points that were done correctly obtaining 5 points if the technique that was done correctly.'}, {'measure': 'Respiratory parameters', 'timeFrame': 'baseline, 12 months', 'description': 'Changes from baseline to postintervention in respiratory parameters using a spirometer as recommended by the American Thoracic Society. The most important respiratory parameters evaluated are forced vital capacity (FVC), carbon dioxide partial pressure (PCO2) and oxygen partial pressure (PO2).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Education', 'Dry Powder Inhalers', 'Metered Dose Inhalers', 'Pulmonary Disease', 'Chronic Obstructive'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is a public health problem with great morbidity. The main therapeutic strategy is inhalers. The objective of this study is to determine the efficacy of an educational intervention in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.', 'detailedDescription': 'The importance of this pathology lies not only in its high prevalence, which is expected to increase due to the aging of society but also in its high mortality. In Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. The clinical development of COPD includes periods of stability interspersed with symptomatic exacerbations, which usually involve hospitalization. During these hospitalizations, respiratory symptoms are worsening.Nevertheless, in Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. Thus, it is very important the pharmacological education in this patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria were to be clinically diagnosed of exacerbation of COPD, to possess pharmacological treatment in the form of inhalers.\n\nExclusion Criteria:\n\n* Exclusion criteria were inability to provide informed consent, presence of psychiatric or cognitive disorders, neurological disorders, organ failure, cancer or inability to cooperate. Patients who had experienced an exacerbation of prior COPD in less than one month were excluded.'}, 'identificationModule': {'nctId': 'NCT03337958', 'briefTitle': 'Education With Inhalers in Patients With COPD Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Evaluation of an Educational Intervention in the Management of Inhalers With Tablet and Ventilatory Reeducation: a Randomized Clinical Study', 'orgStudyIdInfo': {'id': 'DF0071UG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'CONTROL GROUP', 'description': 'Received the standard medical and pharmacological care provided by the hospital'}, {'type': 'EXPERIMENTAL', 'label': 'INTERVENTION GROUP', 'description': 'The group received the standard medical and pharmacological care provided by the hospital. In addition, an educational program on the use of inhalers, which included an explanation of the use of inhalers together with a ventilatory re-education program, furthermore, the technique of inhaler use was trained.', 'interventionNames': ['Device: Ventilatory re-education']}], 'interventions': [{'name': 'Ventilatory re-education', 'type': 'DEVICE', 'description': 'The first day of intervention consisted primarily in ventilatory re-education. During the realization of the technique he was videotaped with a Tablet so that later the patient could be seen and on the video to be able to give him the guidelines for the correction. On the second and third day of the intervention, ventilation re-education was performed and the inhalation technique was subsequently trained.', 'armGroupLabels': ['INTERVENTION GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marie Carmen Valenza, PhD', 'role': 'CONTACT', 'email': 'cvalenza@ugr.es', 'phone': '958242360'}, {'name': 'Marie Carmen Valenza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Physical Therapy', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'centralContacts': [{'name': 'Marie Carmen Valenza, PhD', 'role': 'CONTACT', 'email': 'cvalenza@ugr.es', 'phone': '958 248035'}], 'overallOfficials': [{'name': 'Marie Carmen Valenza, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Marie Carmen Valenza', 'investigatorAffiliation': 'Universidad de Granada'}}}}