AsthmaNCT03047902
Disclosure of Smoking in Adolescents With Asthma
A study testing Group 1 - Parents will be present for the Questionnaire. and Group 2- Parents will not be present for the Questionnaire in people with Asthma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This is an exploratory randomised matched cohort pilot study. It is hypothesised that adolescents (aged 13-16 years) with asthma attending a secondary care outpatient asthma clinic, will disclose their smoking status to a doctor or nurse, if questioned alone without a parent present and if advised that they will have… Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Asthma
- What is being tested?
- Group 1 - Parents will be present for the Questionnaire. and Group 2- Parents will not be present for the Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Apr 2017
- 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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants will be 13-16 years of age at the time of the study.
- Participants will be regular patients of the asthma clinic and will have a diagnosis of asthma
- All patients will have a consultant verification of their asthma diagnosis
- Patients with multisystem atopy will be included in the study
- Only patients accompanied by parents and with parental consent will be enrolled to the study.
Who cannot join
- Patients <13 years
- Patients attending clinic without a parent.
- Patients with special educational needs or communication difficulties
- Patients who don't speak English as a first language, if an interpreter is not
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Whittington Health
London, AL1 5DA
Colette Datt, BSc, 07960 205 270, colette.datt@nhs.net
Amir Hakim, PHd FHEA, 07886361355, a.hakim08@imperial.ac.uk
About this study
This is an exploratory randomised matched cohort pilot study. It is hypothesised that adolescents (aged 13-16 years) with asthma attending a secondary care outpatient asthma clinic, will disclose their smoking status to a doctor or nurse, if questioned alone without a parent present and if advised that they will have biological validation of their smoking status using a carbon monoxide monitor. It is a study of 30 subjects, who will be recruited over a period of 6 months.
Read the detailed description
Background:
There are currently no recommendations for how to obtain accurate information on tobacco use from teenagers aged 13-16 years, who have asthma and are attending a secondary care outpatient clinic. The approach adopted in this study, using a simple questionnaire and Carbon Monoxide monitor to verify smoking status, could potentially allow health care professionals to identify at risk adolescents before they become regular smokers. It is proposed that adolescents will disclose more accurate information about their smoking status if questioned alone without a parent present and if advised that they will have biological validation of their smoking status, using a carbon monoxide monitor.
The objectives of the study are:
- Use a smoking questionnaire, which will be designed with patient and parent feedback and contribution, to measure smoking status in adolescents, attending a secondary care outpatient clinic.
- To assess the appropriateness and acceptability of Carbon Monoxide(CO) monitoring to correlate smoking status in adolescents attending a paediatric outpatient clinic.
Design and Methodology:
All patients will be selected from the paediatric asthma clinic list at Whittington Health. The researcher will approach them with information regarding the research using a Participant Information Sheet. The CO test and the interpretation of the results of the CO test will be explained also. The researcher will consent both the parents and adolescents in both groups for the study and CO test. The adolescent will need to give written informed consent. The adolescents in group 1 (parents present) will be aware that their parents will be able to share the information on the questionnaire, but they will assured of the confidentiality of the CO test. This will also be explained to the parent. The adolescents in group 2 (i.e. parents present) will be assured of the confidentiality of the questionnaire and CO test. The confidentiality of the results will also, be explained to the parent. The parents will consent for their child to take part in the study but the teenagers will also be asked to assent to the study. It would be made clear to the parent that the teenager has a choice to participate and their refusal is not necessarily related to the fact that they may smoke. Irrespective of whether they participate or not all parents and teenagers will have smoking advice discussed with them.
Each consenting participant will be given a short questionnaire to complete. This will include 5-6 questions about their smoking history and how much they smoke and if they have ever tried to give up and how. The questionnaire will also request some basic demographic data and postcode to help identify the potential effects of environmental pollution and passive smoking may have on the results. The questionnaire should take no longer than 5 minutes to complete.
- Conditions
- Asthma
- Being tested
- Group 1 - Parents will be present for the Questionnaire., Group 2- Parents will not be present for the Questionnaire
- Keywords
- Adolescent Smoking Cessation Asthma Carbon Monoxide.
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 - Parents will be present for the Questionnaire.Other
In Group 1 the parents will be present for the questionnaire. The information on the questionnaire will be disclosed to them.
In Group 2 the parents will not be present for the questionnaire and the information will not be disclosed to them.
Group 2- Parents will not be present for the QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Parent Present | Active comparator | The adolescents in group 1 (Parent Present) will be aware that their parents will be able to share the information on the questionnaire, but they will be assured of the confidentiality of the CO test. This will also be explained to the parent.
Intervention: Parents will be present for the questionnaire but not for the CO test. Receives: Other: Group 1 - Parents will be present for the Questionnaire. |
| Parent Absent | Active comparator | The adolescents in group 2 (parents not present) will be assured of the confidentiality of the questionnaire and CO test. The confidentiality of the test will also be explained to the parent.
Intervention: Parents will not be present for the questionnaire or the CO test Receives: Other: Group 2- Parents will not be present for the Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ascertaining smoking status in adolescents with asthma.
To ascertain if adolescents with asthma are more likely to be truthful about smoking status if questioned alone without their parents and with knowledge that this will be verified by carbon monoxide monitoring. This may provide scope for a personal intervention approach to facilitate discussion about smoking cessation intervention strategies and also may be able to be extrapolated to all paediatric outpatient units and GP surgeries.
Measured: 6 months
Secondary outcomes (1)
Evidence base for protocol/guidance
To provide an evidence base for producing a guidance/protocol for how best to obtain a smoking history from adolescents in a collaborative and facilitative way.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startNov 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- The Whittington Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Amir Hakim, PHD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047902
- Sponsor's protocol ID
- 202314
- Status last verified
- Oct 2016
- First submitted
- 7 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disclosure of Smoking in Adolescents With Asthma
- ClinicalTrials.gov ID
- NCT03047902
- Acronym / sponsor ID
- 202314
- Conditions
- Asthma
- Keywords
- Adolescent Smoking Cessation Asthma Carbon Monoxide.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- The Whittington Hospital NHS Trust
- Study start
- Nov 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 9 Feb 2017 (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.
This is an exploratory randomised matched cohort pilot study. It is hypothesised that adolescents (aged 13-16 years) with asthma attending a secondary care outpatient asthma clinic, will disclose their smoking status to a doctor or nurse, if questioned alone without a parent present and if advised that they will have biological validation of their smoking status using a carbon monoxide monitor. It is a study of 30 subjects, who will be recruited over a period of 6 months.
Detailed description
Background:
There are currently no recommendations for how to obtain accurate information on tobacco use from teenagers aged 13-16 years, who have asthma and are attending a secondary care outpatient clinic. The approach adopted in this study, using a simple questionnaire and Carbon Monoxide monitor to verify smoking status, could potentially allow health care professionals to identify at risk adolescents before they become regular smokers. It is proposed that adolescents will disclose more accurate information about their smoking status if questioned alone without a parent present and if advised that they will have biological validation of their smoking status, using a carbon monoxide monitor.
The objectives of the study are:
- Use a smoking questionnaire, which will be designed with patient and parent feedback and contribution, to measure smoking status in adolescents, attending a secondary care outpatient clinic.
- To assess the appropriateness and acceptability of Carbon Monoxide(CO) monitoring to correlate smoking status in adolescents attending a paediatric outpatient clinic.
Design and Methodology:
All patients will be selected from the paediatric asthma clinic list at Whittington Health. The researcher will approach them with information regarding the research using a Participant Information Sheet. The CO test and the interpretation of the results of the CO test will be explained also. The researcher will consent both the parents and adolescents in both groups for the study and CO test. The adolescent will need to give written informed consent. The adolescents in group 1 (parents present) will be aware that their parents will be able to share the information on the questionnaire, but they will assured of the confidentiality of the CO test. This will also be explained to the parent. The adolescents in group 2 (i.e. parents present) will be assured of the confidentiality of the questionnaire and CO test. The confidentiality of the results will also, be explained to the parent. The parents will consent for their child to take part in the study but the teenagers will also be asked to assent to the study. It would be made clear to the parent that the teenager has a choice to participate and their refusal is not necessarily related to the fact that they may smoke. Irrespective of whether they participate or not all parents and teenagers will have smoking advice discussed with them.
Each consenting participant will be given a short questionnaire to complete. This will include 5-6 questions about their smoking history and how much they smoke and if they have ever tried to give up and how. The questionnaire will also request some basic demographic data and postcode to help identify the potential effects of environmental pollution and passive smoking may have on the results. The questionnaire should take no longer than 5 minutes to complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Present | Active comparator | Other: Group 1 - Parents will be present for the Questionnaire.The adolescents in group 1 (Parent Present) will be aware that their parents will be able to share the information on the questionnaire, but they will be assured of the confidentiality of the CO test. This will also be explained to the parent. Intervention: Parents will be present for the questionnaire but not for the CO test. |
| Parent Absent | Active comparator | Other: Group 2- Parents will not be present for the QuestionnaireThe adolescents in group 2 (parents not present) will be assured of the confidentiality of the questionnaire and CO test. The confidentiality of the test will also be explained to the parent. Intervention: Parents will not be present for the questionnaire or the CO test |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participants will be 13-16 years of age at the time of the study.
- Participants will be regular patients of the asthma clinic and will have a diagnosis of asthma
- All patients will have a consultant verification of their asthma diagnosis
- Patients with multisystem atopy will be included in the study
- Only patients accompanied by parents and with parental consent will be enrolled to the study.
Key exclusion criteria (4 listed)
- Patients <13 years
- Patients attending clinic without a parent.
- Patients with special educational needs or communication difficulties
- Patients who don't speak English as a first language, if an interpreter is not
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 |
|---|---|---|
| Group 1 - Parents will be present for the Questionnaire.In Group 1 the parents will be present for the questionnaire. The information on the questionnaire will be disclosed to them. In Group 2 the parents will not be present for the questionnaire and the information will not be disclosed to them. | Other | Parent Present |
| Group 2- Parents will not be present for the Questionnaire | Other | Parent Absent |
Primary outcome
Ascertaining smoking status in adolescents with asthma.
Time frame: 6 months
To ascertain if adolescents with asthma are more likely to be truthful about smoking status if questioned alone without their parents and with knowledge that this will be verified by carbon monoxide monitoring. This may provide scope for a personal intervention approach to facilitate discussion about smoking cessation intervention strategies and also may be able to be extrapolated to all paediatric outpatient units and GP surgeries.
1 secondary outcome
Evidence base for protocol/guidance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Amir Hakim, PHD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 - Parents will be present for the Questionnaire. and Group 2- Parents will not be present for the Questionnaire in people with Asthma, run by Imperial College London at 1 site in United Kingdom.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Feb 2017. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colette Datt, BSC (07827 662081, colette.datt@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ascertaining smoking status in adolescents with asthma. (time frame: 6 months). 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 9 Feb 2017.