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

December 3, 2015 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Arraijan, Panama
        • GSK Investigational Site
      • Barrio Colon, Panama
        • GSK Investigational Site
      • Calidonia, Panama
        • GSK Investigational Site
      • Curundu, Panama
        • GSK Investigational Site
      • El Espino, Panama
        • GSK Investigational Site
      • Guadalupe, La Chorrera, Panama
        • GSK Investigational Site
      • Juán Diaz, Panama
        • GSK Investigational Site
      • La Chorrera, Panama
        • GSK Investigational Site
      • Nuevo Arraijan, Panama
        • GSK Investigational Site
      • Panama, Panama
        • GSK Investigational Site
      • Pueblo Nuevo, Panama
        • GSK Investigational Site
    • Panamá
      • La Chorrera, Panamá, Panama
        • GSK Investigational Site
      • Panama, Panamá, Panama
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Data collection
Paper questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healthcare seeking behaviour of primary caregivers when their child was suspected of having an AOM episode.
Time Frame: During last six months before date of interview.
During last six months before date of interview.

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of suspected AOM based on symptoms reported by the primary caregiver.
Time Frame: During last six months before date of interview.
During last six months before date of interview.
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.
Time Frame: During last six months before date of interview.
During last six months before date of interview.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 18, 2013

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116895

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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