Condition category
Respiratory
Date applied
22/07/2015
Date assigned
23/07/2015
Last edited
07/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Public

Primary contact

Dr Simone Holley

ORCID ID

Contact details

Southampton General Hospital
Mailpoint 803
Southampton University Hospital NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19303

Study information

Scientific title

Improving teenage self-management of asthma: randomised controlled trial

Acronym

ITSMyAsthma RCT

Study hypothesis

The aim of this study is to assess the effectiveness of a teenage asthma toolkit, designed to support healthcare professionals to empower teenagers to self manage their asthma.

Ethics approval

15/NW/0551

Study design

Randomised; Interventional; Design type: Screening, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Children, Respiratory disorders; Subtopic: All Diagnoses, Respiratory (all Subtopics); Disease: Respiratory, All Diseases

Intervention

Clinic – HCPs (doctors and nurses) will use the self-efficacy questionnaire to identify where participants need additional support to improve their asthma self-management skills. The needs of individual patients will then be used to identify specific behavioural interventions. These interventions will be applied in clinic.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The primary outcome measure will be the asthma control test

Secondary outcome measures

N/A

Overall trial start date

15/07/2015

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 12-18 years
2. Able to consent to participation in the study
3. Doctor diagnosed asthma
4. Prescription of a regular prophylactic medication for asthma (eg inhaled corticosteroid, montelukast)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 350; UK Sample Size: 350

Participant exclusion criteria

1. Lack of informed consent from them or their parent
2. Very poorly controlled asthma that, in the view of their paediatrician, requires a step up in preventer therapy
3. Significant other long term medical condition that has a day to day impact on their lives (should not usually include con-existing atopic diseases)

Recruitment start date

15/07/2015

Recruitment end date

31/05/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
Mailpoint 803 Southampton University Hospital NHS Trust Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust & University of Southampton

Sponsor details

University Geriatric Medicine
Level E Centre Block (807)
Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Asthma UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/03/2016: Verifying study status with principal investigator.