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
30/09/2017
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
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