NCT01793857

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 7, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

February 14, 2013

Last Update Submit

December 3, 2015

Conditions

Infections, Streptococcal

Keywords

Primary caregiverSurveyAcute Otitis MediaEar infectionPanamaHealthcare seeking behaviour

Outcome Measures

Primary Outcomes (1)

  • Healthcare seeking behaviour of primary caregivers when their child was suspected of having an AOM episode.

    During last six months before date of interview.

Secondary Outcomes (2)

  • Occurrence of suspected AOM based on symptoms reported by the primary caregiver.

    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.

    During last six months before date of interview.

Study Arms (1)

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

Interventions

Data collectionOTHER

Paper questionnaire

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects having previously participated in this survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

GSK Investigational Site

La Chorrera, Provincia de Panamá, Panama

Location

GSK Investigational Site

Panama City, Provincia de Panamá, Panama

Location

GSK Investigational Site

Arraiján, Panama

Location

GSK Investigational Site

Barrio Colón, Panama

Location

GSK Investigational Site

Calidonia, Panama

Location

GSK Investigational Site

Curundú, Panama

Location

GSK Investigational Site

El Espino, Panama

Location

GSK Investigational Site

Guadalupe, La Chorrera, Panama

Location

GSK Investigational Site

Juán Diaz, Panama

Location

GSK Investigational Site

La Chorrera, Panama

Location

GSK Investigational Site

Nuevo Arraiján, Panama

Location

GSK Investigational Site

Panama City, Panama

Location

GSK Investigational Site

Pueblo Nuevo, Panama

Location

MeSH Terms

Conditions

Streptococcal InfectionsOtitis MediaOtitis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 18, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 7, 2015

Record last verified: 2015-09

Locations

PA(13)