Self-management Intervention to Improve Adolescents' Asthma Control

NCT03536416 | Completed

• 1 other identifier: MGU0400
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

Self-management; Children and young people; Schools

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Medication Adherence Rating Scale.

  15 months

• Unscheduled care

  15 months

• Brief-Illness Perception Questionnaire

  15 months

• School absences

  15 months

• Asthma knowledge

  15 months

Study Arms (3)

Asthma workshop and theatre group

EXPERIMENTAL

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

Theatre only group

ACTIVE COMPARATOR

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

Behavioral: My Asthma in School

Control group

NO INTERVENTION

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

Interventions

My Asthma in School 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.

Asthma workshop and theatre group; Theatre only group

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University of London

London, E1 2AT, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 32884832 BACKGROUND

• 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.

  PMID: 31015270 BACKGROUND

• 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.

  PMID: 29413036 BACKGROUND

• 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.

  PMID: 35321754 RESULT

Related Links

• Project website

MeSH Terms

Conditions

Asthma

Interventions

Schools

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The schools will be randomised, and will not be told which group they have been randomised to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: December 18, 2018
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)