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Disclosure of Smoking in Adolescents With Asthma

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Group 1 - Parents will be present for the Questionnaire.
Group 2- Parents will not be present for the Questionnaire
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Adolescent Smoking Cessation Asthma Carbon Monoxide.

Eligibility Criteria

13 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Whittington HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Parent Present

Parent Absent

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 7, 2017
Last Updated
February 8, 2017
Sponsor
Imperial College London
Collaborators
The Whittington Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03047902
Brief Title
Disclosure of Smoking in Adolescents With Asthma
Official Title
Disclosure of Smoking in Adolescents With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
The Whittington Hospital NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Adolescent Smoking Cessation Asthma Carbon Monoxide.

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parent Present
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Parent Absent
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Group 1 - Parents will be present for the Questionnaire.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group 2- Parents will not be present for the Questionnaire
Primary Outcome Measure Information:
Title
Ascertaining smoking status in adolescents with asthma.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evidence base for protocol/guidance
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colette Datt, BSC
Phone
07827 662081
Email
colette.datt@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Myra Stern, PHD
Phone
0207 288 5353
Email
myra.stern@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Hakim, PHD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Whittington Health
City
London
ZIP/Postal Code
AL1 5DA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colette Datt, BSc
Phone
07960 205 270
Email
colette.datt@nhs.net
First Name & Middle Initial & Last Name & Degree
Amir Hakim, PHd FHEA
Phone
07886361355
Email
a.hakim08@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Colette Datt, BSc

12. IPD Sharing Statement

Plan to Share IPD
No

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Disclosure of Smoking in Adolescents With Asthma

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