Disclosure of Smoking in Adolescents With Asthma
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|ClinicalTrials.gov Identifier: NCT03047902|
Recruitment Status : Unknown
Verified October 2016 by Imperial College London.
Recruitment status was: Recruiting
First Posted : February 9, 2017
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Other: Group 1 - Parents will be present for the Questionnaire. Other: Group 2- Parents will not be present for the Questionnaire||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Disclosure of Smoking in Adolescents With Asthma|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||April 2017|
Active Comparator: Parent Present
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.
Other: 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.
Active Comparator: Parent Absent
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
Other: Group 2- Parents will not be present for the Questionnaire
- 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.
- Evidence base for protocol/guidance [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047902
|Contact: Colette Datt, BSC||07827 firstname.lastname@example.org|
|Contact: Myra Stern, PHD||0207 288 email@example.com|
|London, United Kingdom, AL1 5DA|
|Contact: Colette Datt, BSc 07960 205 270 firstname.lastname@example.org|
|Contact: Amir Hakim, PHd FHEA 07886361355 email@example.com|
|Sub-Investigator: Colette Datt, BSc|
|Principal Investigator:||Amir Hakim, PHD||Imperial College London|