Disclosure of Smoking in Adolescents With Asthma

NCT ID: NCT03047902

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. 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.
2. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Group 1 - Parents will be present for the Questionnaire.

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Group 2- Parents will not be present for the Questionnaire

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Group 2- Parents will not be present for the Questionnaire

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Whittington Hospital NHS Trust

OTHER_GOV

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amir Hakim, PHD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Whittington Health

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Colette Datt, BSC

Role: CONTACT

07827 662081

Myra Stern, PHD

Role: CONTACT

0207 288 5353

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Colette Datt, BSc

Role: primary

07960 205 270

Amir Hakim, PHd FHEA

Role: backup

07886361355

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202314

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Smoke-free Teens Programme
NCT03291132 COMPLETED NA
Researching the Youth Smoking Experience
NCT00156702 COMPLETED PHASE1
Smoking Cessation in Alcoholics
NCT00963482 COMPLETED NA