Self-management Intervention to Improve Adolescents' Asthma Control

Asthma Clinical Trial

— MAIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536416
• Other study ID #: MGU0400
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2022
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• My Asthma in School
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.

Locations

Country	Name	City	State
United Kingdom	Queen Mary University of London	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Harris K, Mosler G, Grigg J. Theory-based self-management intervention to improve adolescents' asthma control: a cluster randomised controlled trial protocol. BMJ Open. 2019 Apr 23;9(4):e025867. doi: 10.1136/bmjopen-2018-025867. — View Citation

Harris K, Newby C, Mosler G, Steed L, Griffiths C, Grigg J. School-based self-management intervention using theatre to improve asthma control in adolescents: a pilot cluster-randomised controlled trial. Pilot Feasibility Stud. 2022 Mar 23;8(1):67. doi: 10 — View Citation

Mosler G, Euba T. Taking control through drama. Lancet. 2018 Jan 27;391(10118):303-304. doi: 10.1016/S0140-6736(17)32283-3. Epub 2017 Sep 8. — View Citation

Mosler G, Harris K, Grigg J, Steed L. Developing a theory-based multimedia intervention for schools to improve young people's asthma: my asthma in school (MAIS). Pilot Feasibility Stud. 2020 Sep 2;6:122. doi: 10.1186/s40814-020-00670-6. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Asthma knowledge	This scale includes 14 questions about asthma knowledge.	15 months
Secondary	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

External Links

•   Project website