Self-management Intervention to Improve Adolescents' Asthma Control

Study Overview
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Brief Summary
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Approximately 1.1 million children and young people in the United Kingdom (UK) are living with asthma, making it the most common chronic disease in children in the UK. Our recent observational study found that poor asthma control, poor medication adherence, and a poor understanding of asthma were key unmet needs of secondary school children. Following the findings from an earlier study, the investigators have developed a preliminary theory-based multi-faceted intervention, aimed at improving asthma self-management and control in young people.

Detailed Description
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The investigators have developed a theory-driven self-management intervention for children and young people which addresses the barriers to successful self-management, which were identified in an earlier study. The intervention will engage asthmatic teenagers and their peers, and will be delivered in two components. The first component includes a theatre workshop for all children aged 11-13 years in London secondary schools. The aim of this component is to raise awareness of asthma in schools among peers. The second component is a series of four self-management workshops for children with asthma. The aim of this component is to teach children about asthma, using interactive role plays and games. The main topics will include asthma general knowledge and understanding; General Practitioner (GP) communication; asthma triggers and symptoms; medication and emergency response; and self-management techniques and goal setting. The children will also receive a toolkit to take home with them, which will include a copy of the workbook that they have used during the day, containing information on what they have learnt. There will also be information on where they can get more help for their asthma. The toolkit will also include information about a smartphone gaming app, which will be about asthma knowledge.

Official Title
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Multifaceted Theory-based Self-management Intervention to Improve Adolescents' Asthma Control: A Cluster-randomised Controlled Trial (RCT)

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: My Asthma in School


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Doctor-diagnosed asthma Aged 11-14 years (UK school years 7-8) Attending the secondary school in which the study is implemented All children in years 7 and 8 in UK secondary schools are eligible to watch the theatre performance Exclusion Criteria: No diagnosis of asthma Not aged 11-14 years (UK school years 7-8) Not attending the school at the time the intervention is delivered

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will include three treatment arms. The first arm will receive the theatre workshop only; the second arm will receive the theatre workshop and the self-management workshops; the control group will receive usual care. Schools will be randomised to one of the groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asthma workshop and theatre group<br>My Asthma in School. This group will receive the self-management workshops for asthmatic children and the theatre performance for the whole year group. | Behavioral: My Asthma in School<br>* The intervention will include three arms. During the theatre workshop, the children will watch a theatre performance, and engage in a discussion at the end of the play, about what they have watched. The self-management workshops will cover a range of topics identified as barriers to self-management in our earlier study, and will be delivered to children with asthma only. The control group will receive usual care during the intervention.<br>|
| Active Comparator: Theatre only group<br>My Asthma in School. This group will receive the theatre performance only. | Behavioral: My Asthma in School<br>* The intervention will include three arms. During the theatre workshop, the children will watch a theatre performance, and engage in a discussion at the end of the play, about what they have watched. The self-management workshops will cover a range of topics identified as barriers to self-management in our earlier study, and will be delivered to children with asthma only. The control group will receive usual care during the intervention.<br>|
| No Intervention: Control group<br>My Asthma in School. The control group will receive usual care for the duration of the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control | This will be measured using the validated Asthma Control Test. Scores range from 5-25. A score of 19 or below indicates poorly controlled asthma; a score of 20 or above indicates good asthma control. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence Rating Scale. | Measures medication adherence. This scale includes 10 questions. Compliance is indicated by a 'no' response to questions 1-6 and 9-10, and a 'yes' response for questions 7 and 8. | 15 months | 
| Unscheduled care | This scale includes two multiple choice questions; one about unplanned doctor visits and one about unplanned hospital emergency department visits over the previous four weeks. | 15 months | 
| Brief-Illness Perception Questionnaire | This scale includes 9 questions about perceptions of illness. Questions 3, 4 and 7 are reverse scored, and added to the scores for the remaining questions. A higher score indicates a more threatening view of the illness. | 15 months | 
| School absences | This scale includes 3 multiple choice questions. These questions measure whole school day absences, lesson absences, and Physical Education lesson absences, over a four-week period. | 15 months | 
| Asthma knowledge | This scale includes 14 questions about asthma knowledge. | 15 months | 
| Beliefs About Medicines Questionnaire | This scale includes 10 statements about asthma medication. The participants indicate their agreement with the statement by selecting an option from strongly agree to strongly disagree. | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Children and young people, Schools