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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01793857
First received: February 14, 2013
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Acute Otitis Media
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media in Children Aged 6 Months to Less Than 30 Months in Panama

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of suspected AOM based on symptoms reported by the primary caregiver. [ Time Frame: During last six months before date of interview. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 1330
Study Start Date: March 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793857

Locations
Panama
GSK Investigational Site
La Chorrera, Panamá, Panama
GSK Investigational Site
Panama, Panamá, Panama
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01793857     History of Changes
Other Study ID Numbers: 116895
Study First Received: February 14, 2013
Last Updated: July 18, 2013
Health Authority: Panama: Comite Nacional de Etica de la Investigación de Panamá (CNEI)

Keywords provided by GlaxoSmithKline:
Primary caregiver
Survey
Acute Otitis Media
Ear infection
Panama
Healthcare seeking behaviour

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014