Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT01711151
Status:
UNKNOWN
Last Update Posted:
2012-10-22
First Post:
2012-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interstitial Lung Disease Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 304}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the Mean K-BILD score between the 4 groups', 'timeFrame': 'Baseline', 'description': 'HRQL'}], 'secondaryOutcomes': [{'measure': 'Severity of dyspnoea suffered by patients', 'timeFrame': 'Baseline'}, {'measure': 'Prevalence of anxiety and depression', 'timeFrame': 'Baseline'}, {'measure': 'Prevalence of sleep-disordered breathing symptoms', 'timeFrame': 'Baseline'}, {'measure': 'Degree of self-awareness displayed by patients', 'timeFrame': 'Baseline'}, {'measure': 'The costs associated with ILD from a patient and healthcare perspective', 'timeFrame': 'Baseline'}, {'measure': 'Demographic details', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ILD'], 'conditions': ['Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': '1. To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how this varies between subgroups of ILD.\n2. To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered breathing within ILD patient population.\n3. To assess the economic impact of ILD.\n4. To understand how self-aware ILD patients are regarding their treatment/management.\n5. To compare the demographic details, including smoking status and occupational history, of patients with interstitial lung disease', 'detailedDescription': 'Primary endpoint\n\n• Health status in the target populations, as determined by the K-BILD questionnaire.\n\nSecondary endpoints -\n\n* Severity of dyspnoea suffered by patients\n* Prevalence of anxiety and depression\n* Prevalence of sleep-disordered breathing symptoms\n* Degree of self-awareness displayed by patients\n* The costs associated with ILD from a patient and healthcare perspective.\n* Demographic details'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Secondary Care', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Age greater than 18 years of age\n* Any smoking status\n* Diagnosis of Interstitial Lung Disease as defined below\n* Full pulmonary lung function tests and routine immunological tests undertaken within 6 months of entry into study\n\nExclusion Criteria:\n\n• Unable to give consent to take part'}, 'identificationModule': {'nctId': 'NCT01711151', 'briefTitle': 'Interstitial Lung Disease Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'University of East Anglia'}, 'officialTitle': 'Questionnaire Study for Patients With Interstitial Lung Disease', 'orgStudyIdInfo': {'id': '2012RESP05'}, 'secondaryIdInfos': [{'id': 'UEAILDQUEST', 'type': 'OTHER', 'domain': 'University of East Anglia'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Idiopathic Pulmonary Fibrosis', 'description': 'Questionnaire evaluation'}, {'label': 'Non Idiopathic Pulmonary Fibrosis', 'description': 'Questionnaire evaluation'}, {'label': 'Sarciodosis', 'description': 'Questionnaire evaluation'}, {'label': 'Healthy Controls', 'description': 'Questionnaire evaluation'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NR47UY', 'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'contacts': [{'name': 'Christopher Atkins', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Norfolk and Norwich Univeristy Hospital NHS foundation Trust', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}], 'centralContacts': [{'name': 'Andrew M Wilson, MRCP, MD', 'role': 'CONTACT', 'email': 'a.m.wilson@uea.ac.uk', 'phone': '00441603591257'}, {'name': 'Christopher Atkins, MBBS, MRCP', 'role': 'CONTACT', 'email': 'christopher.atkins@nnuh.nhs.uk', 'phone': '00441603286286'}], 'overallOfficials': [{'name': 'Andrew M Wilson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of East Anglia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of East Anglia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}