Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-27 @ 3:47 PM
Study NCT ID:
NCT01793857
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2013-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2013-02-14', 'studyFirstSubmitQcDate': '2013-02-14', 'lastUpdatePostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare seeking behaviour of primary caregivers when their child was suspected of having an AOM episode.', 'timeFrame': 'During last six months before date of interview.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of suspected AOM based on symptoms reported by the primary caregiver.', 'timeFrame': 'During last six months before date of interview.'}, {'measure': 'Potential determinants (such as access to healthcare facilities) influencing healthcare seeking behaviour of primary caregivers who suspected their child aged 6 months to < 30 months of having an AOM episode during the last six months.', 'timeFrame': 'During last six months before date of interview.'}]}, 'conditionsModule': {'keywords': ['Primary caregiver', 'Survey', 'Acute Otitis Media', 'Ear infection', 'Panama', 'Healthcare seeking behaviour'], 'conditions': ['Infections, Streptococcal']}, 'descriptionModule': {'briefSummary': 'The study is a survey aiming to describe the healthcare seeking behaviour of primary caregivers when their child aged 6 months to less than 30 months was suspected to have an episode of acute otitis media in Panama.', 'detailedDescription': "The study is a cross sectional survey in which primary caregivers will be asked if they recall having observed an ear infection in the child in the age range 6 months to less than 30 months in the last 6 months. During the interview, the primary caregivers will be asked what they did for the child during that episode and whether they sought medical care or not. They will be also asked about the demographic characteristics (such as age range) of the child who experienced that episode and the household environment of the child at the time of the episode (such as number of household members), etc.\n\nNo questions will be asked about the episode itself if the primary caregiver does not recall that the child had one in the last six months.\n\nApproximately 1300 primary caregivers will be interviewed in multiple clinics / well-baby clinics in Panama.\n\nThe clinics will be stratified into 'former clinical trial sites' and 'non-clinical trial sites' in urban areas of Panama, based on participation in the COMPAS trial. Both 'former clinical trial sites' and 'non-clinical trial sites' will include private and public facilities. Sites will be selected by convenience sampling and eligible subjects will be enrolled on an on-going basis, in proportion to the population coverage of each site. The participating sites have thus been stratified to be able to assess whether the healthcare seeking behaviour of primary caregivers enrolled at former clinical trial sites are different from those enrolled at non clinical trial sites."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary caregivers with at least one child aged 6 months to less than 30 months visiting a clinic in Panama primarily for well-baby visits or sickness visit.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator/interviewer believes can and will comply with the requirements of the protocol (e.g. availability of time for completion of the interview).\n* Signed informed consent obtained from the subject.\n* Subjects aged 18 years or above, being the primary caregiver of at least one child aged 6 months to less than 30 months, visiting a clinic.\n\nNote:\n\ni. Although the child will most likely be present at the time of interview, his/her presence is not required.\n\nii. If more than one primary caregiver fulfilling the inclusion criteria is present per child, only one will be enrolled in this study.\n\nExclusion Criteria:\n\n• Subjects having previously participated in this survey.'}, 'identificationModule': {'nctId': 'NCT01793857', 'briefTitle': 'Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media in Children Aged 6 Months to Less Than 30 Months in Panama', 'orgStudyIdInfo': {'id': '116895'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'Approximately 1300 primary caregivers of at least one child aged 6 months to less than 30 months who were interviewed during a clinic visit in Panama.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Paper questionnaire', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Chorrera', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'GSK Investigational Site'}, {'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Arraiján', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.9398, 'lon': -79.64038}}, {'city': 'Barrio Colón', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.89427, 'lon': -79.76515}}, {'city': 'Calidonia', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 7.95756, 'lon': -81.38633}}, {'city': 'Curundú', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.97092, 'lon': -79.54612}}, {'city': 'El Espino', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.83919, 'lon': -79.84671}}, {'city': 'Guadalupe, La Chorrera', 'country': 'Panama', 'facility': 'GSK Investigational Site'}, {'city': 'Juán Diaz', 'country': 'Panama', 'facility': 'GSK Investigational Site'}, {'city': 'La Chorrera', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.87763, 'lon': -79.78007}}, {'city': 'Nuevo Arraiján', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.92643, 'lon': -79.72023}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Pueblo Nuevo', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.8807, 'lon': -82.22411}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}