Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-03-07 @ 9:26 PM
Study NCT ID:
NCT03797768
Status:
UNKNOWN
Last Update Posted:
2021-01-28
First Post:
2019-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1438}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in 1 second', 'timeFrame': '1 year', 'description': 'Mean difference in FVE1 between intervention and control arm'}], 'secondaryOutcomes': [{'measure': 'Proportion of risk factors of COPD between intervention and control arm', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '33061350', 'type': 'BACKGROUND', 'citation': 'Adhikari TB, Acharya P, Hogman M, Neupane D, Karki A, Drews A, Cooper BG, Sigsgaard T, Kallestrup P. Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey. Int J Chron Obstruct Pulmon Dis. 2020 Sep 29;15:2319-2331. doi: 10.2147/COPD.S268110. eCollection 2020.'}, {'pmid': '34289879', 'type': 'DERIVED', 'citation': 'Adhikari TB, Neupane D, Karki A, Drews A, Cooper B, Hogman M, Sigsgaard T, Kallestrup P. Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial): study protocol for a cluster-randomized controlled trial. Trials. 2021 Jul 21;22(1):474. doi: 10.1186/s13063-021-05447-7.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.2147/COPD.S268110', 'label': 'Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey'}]}, 'descriptionModule': {'briefSummary': 'Chronic Obstructive Pulmonary Disease (COPD) is the fourth most important cause of death worldwide and is one of the commonest non-communicable diseases (NCDs) in Nepal. The presence of risk factors like indoor and outdoor air pollution, the high prevalence of smoking and lack of general awareness of COPD makes it a serious public health concern. However, no attempt has been made in Nepal to estimate its burden and address the disease at the community level. This community-based cluster randomized controlled study aims to fulfil that gap through mobilization of Female Community Health Workers (FCHVs) who will be trained to perform a certain set of health promotion activities aimed at prevention of the disease and its progression. Baseline and follow-up surveys will be conducted to compare the intervention and control groups. This study has the potential to generate evidence in helping address NCDs in Nepal and also other similar resource-limited countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable of performing spirometry\n* Aged greater than and equal to 40 years\n* Full time residents in the study area and will be in the study area for at least one year\n\nExclusion Criteria:\n\n* Younger than 40 years of age\n* Self-reported pregnancy\n* having active pulmonary tuberculosis or being on medications for pulmonary tuberculosis\n* thoracic, abdominal or eye surgery in the last six months\n* History of Mental illness\n* MI in past 8 weeks prior to study\n* Hospital admission in the past six months for cardiac illness\n* Those who decline to provide consent to the study will be excluded.'}, 'identificationModule': {'nctId': 'NCT03797768', 'acronym': 'COBIN-P', 'briefTitle': 'Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Protocol for Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal: a Community-based Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AUTBA18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: Behavioural-FCHV Visit']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Behavioural-FCHV Visit', 'type': 'BEHAVIORAL', 'description': 'Female Community Health Volunteer will visit selected households on average 3 times a year for providing health promotion messages on improving lung health status and avoiding risk factors to COPD.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Tara Ballav Adhikari, MScPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}