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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media in Children Aged 6 Months to Less Than 30 Months in Panama
- ClinicalTrials.gov ID
- NCT01793857
- Acronym / sponsor ID
- 116895
- Conditions
- Infections, Streptococcal
- Keywords
- Primary caregiver, Survey, Acute Otitis Media, Ear infection, Panama, Healthcare seeking behaviour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,330 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Data collectionApproximately 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- Subjects having previously participated in this survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionPaper questionnaire | Other | Study Group |
Primary outcome
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.
2 secondary outcomes
Occurrence of suspected AOM based on symptoms reported by the primary caregiver.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 13 sites in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.