Upper Respiratory InfectionNCT01916031
Appropriate Care of URI (ACURI): Early Head Start
A study testing Education in people with Upper Respiratory Infection, run by Columbia University.
Trial summary
The purpose of this study is to comparatively assess the effectiveness of a tailored educational intervention to improve health literacy levels regarding upper respiratory infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino households in Early Head Start. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Upper Respiratory Infection
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento May 2010
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Attending an infant or toddler EHS group at participating site
Who cannot join
- Participant in pilot study
- Participant in community intervention regarding URI
About this study
The purpose of this study is to comparatively assess the effectiveness of a tailored educational intervention to improve health literacy levels regarding upper respiratory infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino households in Early Head Start.
- Conditions
- Upper Respiratory Infection
- Being tested
- Education
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Upper Respiratory Infection education in Fall Receives: Behavioral: Education |
| Standard Curriculum | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pediatric emergency department visits
Measured: 5 months
Secondary outcomes (4)
Use of over-the-counter medication
Measured: 5 months
Use of incorrect measuring tool
Measured: 5 months
Use of unprescribed antibiotic
Measured: 5 months
Knowledge regarding URI
Composite score
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Stockwell, MD, MPH, Columbia University
- Investigators
- Melissa Stockwell, MD MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916031
- Sponsor's protocol ID
- AAAD7081
- Status last verified
- Aug 2013
- First submitted
- 1 Aug 2013
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Stockwell MS, Catallozzi M, Larson E, Rodriguez C, Subramony A, Andres Martinez R, Martinez E, Barrett A, Meyer D. Effect of a URI-related educational intervention in early head start on ED visits. Pediatrics. 2014 May;133(5):e1233-40. doi: 10.1542/peds.2013-2350. Epub 2014 Apr 7.
PubMed 24709931
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Care of URI (ACURI): Early Head Start
- ClinicalTrials.gov ID
- NCT01916031
- Acronym / sponsor ID
- AAAD7081
- Conditions
- Upper Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Aug 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 purpose of this study is to comparatively assess the effectiveness of a tailored educational intervention to improve health literacy levels regarding upper respiratory infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino households in Early Head Start.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: EducationUpper Respiratory Infection education in Fall |
| Standard Curriculum | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Attending an infant or toddler EHS group at participating site
Key exclusion criteria (2 listed)
- Participant in pilot study
- Participant in community intervention regarding URI
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 |
|---|---|---|
| Education | Behavioural | Education |
Primary outcome
Number of pediatric emergency department visits
Time frame: 5 months
4 secondary outcomes
Use of over-the-counter medication
Time frame: 5 months
Use of incorrect measuring tool
Time frame: 5 months
Use of unprescribed antibiotic
Time frame: 5 months
Knowledge regarding URI
Time frame: 5 months
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 5 Aug 2013.
- Derived from this study: PubMed 24709931Stockwell MS, Catallozzi M, Larson E, Rodriguez C, Subramony A, Andres Martinez R, Martinez E, Barrett A, Meyer D. Effect of a URI-related educational intervention in early head start on ED visits. Pediatrics. 2014 May;133(5):e1233-40. doi: 10.1542/peds.2013-2350. Epub 2014 Apr 7.
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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.
Melissa Stockwell, MD MPH principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Upper Respiratory Infection, run by Columbia University.
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 1 inclusion and 2 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 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of pediatric emergency department visits (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916031, which also lists 1 linked publication.
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 5 Aug 2013.