NCT03047902

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 9, 2017

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

February 7, 2017

Last Update Submit

February 8, 2017

Conditions

Asthma

Keywords

Adolescent Smoking Cessation Asthma Carbon Monoxide.

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Evidence base for protocol/guidance

    1 year

Study Arms (2)

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.

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

Other: Group 2- Parents will not be present for the Questionnaire

Interventions

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.

Parent Present
Group 2- Parents will not be present for the QuestionnaireOTHER
Parent Absent

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whittington Health

London, AL1 5DA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Amir Hakim, PHD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colette Datt, BSC

CONTACT

07827 662081colette.datt@nhs.net

Myra Stern, PHD

CONTACT

0207 288 5353myra.stern@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

November 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 9, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)