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

Infections, Streptococcal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793857
• Other study ID #: 116895
• Status: Completed
• Phase: N/A
• First received: February 14, 2013
• Last updated: December 3, 2015
• Start date: March 2013
• Est. completion date: May 2013

Study information

• Verified date: September 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Comite Nacional de Etica de la Investigación de Panamá (CNEI)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1330
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Family-Based, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Infections, Streptococcal
• Otitis Media
• Streptococcal Infections

Intervention

Other:
• Data collection
Paper questionnaire

Locations

Country	Name	City	State
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	La Chorrera	Panamá
Panama	GSK Investigational Site	Nuevo Arraijan
Panama	GSK Investigational Site	Panama
Panama	GSK Investigational Site	Panama	Panamá
Panama	GSK Investigational Site	Pueblo Nuevo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare seeking behaviour of primary caregivers when their child was suspected of having an AOM episode.		During last six months before date of interview.	No
Secondary	Occurrence of suspected AOM based on symptoms reported by the primary caregiver.		During last six months before date of interview.	No
Secondary	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.		During last six months before date of interview.	No