Infections, StreptococcalNCT01793857
Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 13 sites in Panama.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Data collection
- How many people
- 1,330 participants
- Where
- 13 sitesPanama
- Study dates
- Mar 2013to May 2013
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
- Although the child will most likely be present at the time of interview, his/her presence is not required.
- If more than one primary caregiver fulfilling the inclusion criteria is present per child, only one will be enrolled in this study.
Who cannot join
- Subjects having previously participated in this survey.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Panama13 sites
GSK Investigational Site
Arraiján
GSK Investigational Site
Barrio Colón
GSK Investigational Site
Calidonia
GSK Investigational Site
Curundú
GSK Investigational Site
El Espino
GSK Investigational Site
Guadalupe, La Chorrera
GSK Investigational Site
Juán Diaz
GSK Investigational Site
La Chorrera, Provincia de Panamá
GSK Investigational Site
La Chorrera
GSK Investigational Site
Nuevo Arraiján
GSK Investigational Site
Panama City, Provincia de Panamá
GSK Investigational Site
Panama City
GSK Investigational Site
Pueblo Nuevo
About this study
Official title: 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.
Read the 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.
- Conditions
- Infections, Streptococcal
- Being tested
- Data collection
- Keywords
- Primary caregiver, Survey, Acute Otitis Media, Ear infection, Panama, Healthcare seeking behaviour
- Medical subject headings
- Streptococcal Infections, Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Paper questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare seeking behaviour of primary caregivers when their child was suspected of having an AOM episode.
Measured: During last six months before date of interview.
Secondary outcomes (2)
Occurrence of suspected AOM based on symptoms reported by the primary caregiver.
Measured: 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.
Measured: During last six months before date of interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 1,330 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793857
- Sponsor's protocol ID
- 116895
- Status last verified
- Sep 2015
- First submitted
- 14 Feb 2013
- Last updated
- 7 Dec 2015
- Results posted
- No