Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media in Children Aged 6 Months to Less Than 30 Months in Panama
Data Collection
Collected at a single point in time - Cross-sectionalBacterial Infections and Mycoses+6
+ Bacterial Infections
+ Ear Diseases
Family-Based
Studying health outcomes within families in order to identify genetic or familial contributions to disease.Summary
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.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. No 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. Approximately 1300 primary caregivers will be interviewed in multiple clinics / well-baby clinics in Panama. The 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1330 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Family-Based
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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). Signed informed consent obtained from the subject. 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. Note: i. Although the child will most likely be present at the time of interview, his/her presence is not required. ii. If more than one primary caregiver fulfilling the inclusion criteria is present per child, only one will be enrolled in this study. Exclusion Criteria: • Subjects having previously participated in this survey.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
GSK Investigational Site
Panama City, PanamaGSK Investigational Site
Arraiján, PanamaGSK Investigational Site
Barrio Colón, Panama