CoughNCT03126851
Promoting Safe Use of Children's Cough/Cold Medicines
A study testing Label in people with Cough, run by NYU Langone Health at 1 site in United States.
Trial summary
This study seeks to identify ways to help parents safely use cough/cold medications with their children. The study focuses on 3 key tasks that have been found to be difficult for parents: 1) decision-making about whether medicines should be given based on a child's age, 2) use of active ingredient information to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- Label
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 10 Aug 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent/Legal guardian 18 years or older
- Parent/Legal guardian with children <6 years old
- English or Spanish speaking
Who cannot join
- Visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
- Uncorrectable hearing impairment
- Parents/ children too ill to participate will also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Identifying "Best Practices" for the Safe Use of Pediatric Cough and Cold Medications
This study seeks to identify ways to help parents safely use cough/cold medications with their children. The study focuses on 3 key tasks that have been found to be difficult for parents: 1) decision-making about whether medicines should be given based on a child's age, 2) use of active ingredient information to determine which medications are safe to give together, and 3) medication dosing.
Specific ways that labels and dosing tools can be changed to improve parent understanding and ability to use pediatric cough and cold medications will be tested. This includes looking at whether including age restriction information on the front panel helps parents make better decisions about whether a medication should be given to a child, as well as whether presence of a specific warning or pictogram can help improve this understanding. In addition, the role of font size, including a box around ingredients, and use of a specific warning to look at and compare active ingredients, will be examined to see if these can help parents decide if two medications can be given together safely. Finally, dosing charts with pictograms of dosing tools, and provision of certain dosing tools, can lead to fewer parent dosing errors.
Read more
A label/dosing tool combination that incorporates what is learned from the first part of the study will be developed based on findings from the first part of the study, and then tested to see whether this improves parent understanding and use of pediatric cough and cold medicines.
Hypotheses include: 1) changes in labels and dosing tools, such as including explicit warnings, and pictographic warnings/instructions can improve parent understanding and ability to act on of medication instructions, 2) parents with low health literacy and/or LEP will especially benefit from strategies such as explicit wording, warnings, and pictogram, and 3) parents receiving the comprehensive labeling and dosing strategy will have a better understanding of appropriate use of cough/cold medications, including fewer dosing errors, compared to standard labels.
A multi-part experiment will be conducted. Findings will be merged with known evidence around health literacy best practices to develop a comprehensive, consumer-centered strategy for English and Spanish-speaking parents. Pilot testing of the comprehensive strategy in comparison to existing labels will then take place.
Read the detailed description
See Brief summary.
- Conditions
- Cough
- Being tested
- Label
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabelOther
Labels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon.
| Study group | Role | What they receive |
|---|---|---|
| No age range / no explicit warning | Experimental | Label: No age range and no explicit warning on front display panel of medication box. Receives: Other: Label |
| age range / no explicit warning | Experimental | Label: Age range present but no explicit warning on front display panel of medication box. Receives: Other: Label |
| age range / explicit warning in words | Experimental | Label: Age range present with explicit warning in words on front display panel of medication box. Receives: Other: Label |
| age range / explicit warning+pictogram | Experimental | Label: Age range present with explicit warning in words plus pictographic warning on front display panel of medication box. Receives: Other: Label |
What is being measured
The primary outcome is the main question the study is designed to answer.
# of parents making correct decision about whether medication should be given based on age restriction information (survey)
# of parents making correct decision about whether medication should be given to their child based on age restriction information, assessed by survey question
Measured: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
Secondary outcomes (1)
# of parents with correct knowledge of age group that medication can be given to (survey)
# of parents with correct knowledge of the age of the youngest and oldest child the medication can be given to, assessed by survey questions
Measured: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 May 2017
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shonna Yin, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126851
- Sponsor's protocol ID
- 15-01510
- Status last verified
- Jun 2023
- First submitted
- 13 Apr 2017
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying "Best Practices" for the Safe Use of Pediatric Cough and Cold Medications
- ClinicalTrials.gov ID
- NCT03126851
- Acronym / sponsor ID
- 15-01510
- Conditions
- Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- 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.
This study seeks to identify ways to help parents safely use cough/cold medications with their children. The study focuses on 3 key tasks that have been found to be difficult for parents: 1) decision-making about whether medicines should be given based on a child's age, 2) use of active ingredient information to determine which medications are safe to give together, and 3) medication dosing.
Specific ways that labels and dosing tools can be changed to improve parent understanding and ability to use pediatric cough and cold medications will be tested. This includes looking at whether including age restriction information on the front panel helps parents make better decisions about whether a medication should be given to a child, as well as whether presence of a specific warning or pictogram can help improve this understanding. In addition, the role of font size, including a box around ingredients, and use of a specific warning to look at and compare active ingredients, will be examined to see if these can help parents decide if two medications can be given together safely. Finally, dosing charts with pictograms of dosing tools, and provision of certain dosing tools, can lead to fewer parent dosing errors.
A label/dosing tool combination that incorporates what is learned from the first part of the study will be developed based on findings from the first part of the study, and then tested to see whether this improves parent understanding and use of pediatric cough and cold medicines.
Hypotheses include: 1) changes in labels and dosing tools, such as including explicit warnings, and pictographic warnings/instructions can improve parent understanding and ability to act on of medication instructions, 2) parents with low health literacy and/or LEP will especially benefit from strategies such as explicit wording, warnings, and pictogram, and 3) parents receiving the comprehensive labeling and dosing strategy will have a better understanding of appropriate use of cough/cold medications, including fewer dosing errors, compared to standard labels.
A multi-part experiment will be conducted. Findings will be merged with known evidence around health literacy best practices to develop a comprehensive, consumer-centered strategy for English and Spanish-speaking parents. Pilot testing of the comprehensive strategy in comparison to existing labels will then take place.
Detailed description
See Brief summary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No age range / no explicit warning | Experimental | Other: LabelLabel: No age range and no explicit warning on front display panel of medication box. |
| age range / no explicit warning | Experimental | Other: LabelLabel: Age range present but no explicit warning on front display panel of medication box. |
| age range / explicit warning in words | Experimental | Other: LabelLabel: Age range present with explicit warning in words on front display panel of medication box. |
| age range / explicit warning+pictogram | Experimental | Other: LabelLabel: Age range present with explicit warning in words plus pictographic warning on front display panel of medication box. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent/Legal guardian 18 years or older
- Parent/Legal guardian with children <6 years old
- English or Spanish speaking
Key exclusion criteria (3 listed)
- Visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
- Uncorrectable hearing impairment
- Parents/ children too ill to participate will also be excluded
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 |
|---|---|---|
| LabelLabels vary based on presence or absence of age range information, and inclusion of an explicit warning in words, with or without a pictographic icon. | Other | No age range / no explicit warning, age range / explicit warning in words, age range / explicit warning+pictogram, age range / no explicit warning |
Primary outcome
# of parents making correct decision about whether medication should be given based on age restriction information (survey)
Time frame: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
# of parents making correct decision about whether medication should be given to their child based on age restriction information, assessed by survey question
1 secondary outcome
# of parents with correct knowledge of age group that medication can be given to (survey)
Time frame: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)
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 3 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Shonna Yin, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Label in people with Cough, run by NYU Langone Health at 1 site in United States.
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 3 inclusion and 3 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
# of parents making correct decision about whether medication should be given based on age restriction information (survey) (time frame: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)). 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 3 Jul 2023.