Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infections, Streptococcal

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study Group

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.

Data collection

Intervention Type OTHER

Paper questionnaire

Interventions

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Data collection

Paper questionnaire

Intervention Type OTHER

Eligibility Criteria

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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.

Exclusion Criteria

• Subjects having previously participated in this survey.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

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116895

Identifier Type: -

Identifier Source: org_study_id

Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Study Group

Data collection

Interventions

Data collection

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GlaxoSmithKline

Responsible Party

Principal Investigators

GSK Clinical Trials

Locations

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Countries

Other Identifiers

116895