Self-management Intervention to Improve Adolescents' Asthma Control

NCT ID: NCT03536416

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2022-08-31

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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
The schools will be randomised, and will not be told which group they have been randomised to.

Study Groups

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Asthma workshop and theatre group

My Asthma in School. This group will receive the self-management workshops for asthmatic children and the theatre performance for the whole year group.

Group Type EXPERIMENTAL

My Asthma in School

Intervention Type BEHAVIORAL

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.

Theatre only group

My Asthma in School. This group will receive the theatre performance only.

Group Type ACTIVE_COMPARATOR

My Asthma in School

Intervention Type BEHAVIORAL

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.

Control group

My Asthma in School. The control group will receive usual care for the duration of the intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Grigg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Queen Mary University of London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 32884832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31015270 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 29413036 (View on PubMed)

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: 10.1186/s40814-022-01031-1.

Reference Type RESULT
PMID: 35321754 (View on PubMed)

Related Links

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Other Identifiers

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MGU0400

Identifier Type: -

Identifier Source: org_study_id

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