Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT01117493
Status:
COMPLETED
Last Update Posted:
2010-05-05
First Post:
2010-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073278', 'term': 'Self-Management'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-04', 'studyFirstSubmitDate': '2010-05-04', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-efficacy', 'timeFrame': '8 months', 'description': 'Self efficacy is measured using the Chronic Disease Self Efficacy Scale. Confidence is measured on a 1-10 point Likert scale for 10 subscales. There are no specific units for this measurement.'}], 'secondaryOutcomes': [{'measure': 'Perception of illness', 'timeFrame': '8 months', 'description': 'Perception of illness is measured using the Illness Perception Questionnaire - revised IPQ-R. This questionnaire has 8 domains. Minimum score 52 and maximum 204. There are no specific units for this measurement.'}, {'measure': 'Health related quality of life', 'timeFrame': '8 months', 'description': 'Health related quality of life is measured using the St Georges Respiratory Questionnaire. This questionnaire has 3 domains. Min-max scores 0-100%'}, {'measure': 'Self rated health', 'timeFrame': '8 months', 'description': 'An expert patient programme questionnaire is used to record self rated health, management of condition, days lost to work and social activities, satisfaction and benefits. There are no specific units for this measurement.'}, {'measure': 'Lung function', 'timeFrame': '8 months', 'description': 'Spirometric measurement of FEV1 expressed as a percentage predicted is used to assess lung function'}, {'measure': 'Rate of exacerbation', 'timeFrame': '8 months', 'description': 'Frequency of antibiotics is recorded to assess rate of exacerbation. These will be expressed as the number of antibiotics prescribed per group during the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bronchiectasis']}, 'descriptionModule': {'briefSummary': 'The aim of this exploratory randomized controlled trial was to investigate the efficacy of a disease specific Expert Patient Programme compared to usual care in patients with bronchiectasis. Hypothesis: Disease specific EPP will increase self efficacy compared to usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients (\\>18 years) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomography scan were included in the study\n\nExclusion Criteria:\n\n* Primary diagnosis of cystic fibrosis\n* Patients with methicillin-resistant Staphylococcus aureus infection\n* Patients with any condition that would have an impact on the assessment procedures (e.g. sensory impairment, pregnancy, language barriers)\n* Any factor that would prevent adherence to the self-management programme."}, 'identificationModule': {'nctId': 'NCT01117493', 'briefTitle': 'Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Belfast Health and Social Care Trust'}, 'officialTitle': 'Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis', 'orgStudyIdInfo': {'id': '06054JB-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Usual care', 'description': 'Usual care included reviews at a specialist respiratory clinic on a three monthly basis to monitor spirometry, inflammatory blood markers and sputum microbiology. The patients were prescribed inhaled therapy and antibiotics if required, and treatment adjusted to the needs of the patient as necessary, including hospital admission.', 'interventionNames': ['Behavioral: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Expert Patient Programme', 'description': 'Receives a disease specific Expert Patient Programme in addition to usual care. The disease specific Expert Patient Programme was delivered one session per week (lasting 2½ hours) for eight weeks and included 2 weeks disease specific education followed by 6 weeks standardised Expert Patient Programme.', 'interventionNames': ['Behavioral: Expert Patient Programme']}], 'interventions': [{'name': 'Expert Patient Programme', 'type': 'BEHAVIORAL', 'otherNames': ['Self-management'], 'description': 'Intervention was a disease specific Expert Patient Programme in addition to usual care. The disease specific Expert Patient Programme was delivered one session per week (lasting 2½ hours) for eight weeks and included 2 weeks disease specific education followed by 6 weeks standardised Expert Patient Programme.', 'armGroupLabels': ['Expert Patient Programme']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'otherNames': ['Usual management'], 'description': 'Usual care included reviews at a specialist respiratory clinic on a three monthly basis to monitor spirometry, inflammatory blood markers and sputum microbiology. The patients were prescribed inhaled therapy and antibiotics if required, and treatment adjusted to the needs of the patient as necessary, including hospital admission.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Judy M Bradley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Belfast Health and Social Care Trust & University of Ulster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Belfast Health and Social Care Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ulster', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Judy Bradley', 'oldOrganization': 'Belfast Health and Social Care TRust'}}}}