Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-28 @ 3:34 PM
Study NCT ID:
NCT05762861
Status:
UNKNOWN
Last Update Posted:
2023-03-10
First Post:
2021-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2021-06-20', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of COPD exacerbation with hospital admission', 'timeFrame': '18 months'}, {'measure': 'Number of COPD exacerbation managed at home', 'timeFrame': '18 months'}, {'measure': "Quality of Life using St. George's Respiratory Questionnaire", 'timeFrame': '18 months', 'description': 'Scores range from 0 (no effect on quality of life) to a maximum score of 100 (maximum perceived distress). A higher score means a poorer quality of life'}, {'measure': "Impact of COPD on patient's life using COPD Assessment Test (CAT)", 'timeFrame': '18 months', 'description': "Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life."}, {'measure': 'Impact of the programme - rate of compliance', 'timeFrame': '18 months', 'description': 'Measurement tool - questionnaire'}, {'measure': 'Impact of the programme - satisfaction level', 'timeFrame': '18 months', 'description': 'Measurement tool - questionnaire'}, {'measure': 'Impact of the programme - % of retention of participating patients', 'timeFrame': '18 months', 'description': 'Measurement tool - questionnaire'}], 'secondaryOutcomes': [{'measure': 'Pulmonary function (FEV1 and FEV1/ FVC ratio after BD)', 'timeFrame': '18 months'}, {'measure': 'Dyspnoea level (mMRC)', 'timeFrame': '18 months'}, {'measure': 'Changes in GOLD classification', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD Exacerbation']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to assess the feasibility and benefits of the implementation of an interactive telemonitoring system for earlier detection of COPD exacerbations in a community cohort preventing further deterioration requiring hospital admissions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD\n* Aged 40 years or above\n* Must be enrolled in health centres from Braga'}, 'identificationModule': {'nctId': 'NCT05762861', 'acronym': 'EPISODE', 'briefTitle': 'Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University of Minho'}, 'officialTitle': 'Exploring Clinical Predictors of COPD Exacerbation in a Community Cohort', 'orgStudyIdInfo': {'id': 'ISS 10805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual follow up', 'description': 'Group 1: To keep follow-up in their usual family practice/ pulmonology consultations'}, {'type': 'EXPERIMENTAL', 'label': 'Home telemonitoring', 'description': 'Group 2: To keep follow-up in their usual family practice/ pulmonology consultations and associate an interactive home telemonitoring system managed by the researchers.', 'interventionNames': ['Other: Experimental']}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'otherNames': ['Telemonitoring'], 'description': "Patients will be every two weeks monitored by the researchers' team, taking into consideration lung function, symptoms, physical activity, pulse oximetry, body temperature, need for relief medication and Sputum characteristics. Over the 18 months, they will be the target of health education interventions, 2 individual and 2 in group.", 'armGroupLabels': ['Home telemonitoring']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maria João Barbosa, MD', 'role': 'CONTACT', 'email': 'mijoao@gmail.com', 'phone': '00351968123187'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minho', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Maria Joao Barbosa', 'investigatorAffiliation': 'University of Minho'}}}}