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Completed

NCT Number: NCT03536416

Self-management Intervention to Improve Adolescents' Asthma Control

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.

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Key information

Conditions

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

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary University of London

London, E1 2AT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Asthma control

    Time frame: 15 months

    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.

Secondary outcomes

  1. Medication Adherence Rating Scale.

    Time frame: 15 months

    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.

  2. Unscheduled care

    Time frame: 15 months

    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.

  3. Brief-Illness Perception Questionnaire

    Time frame: 15 months

    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.

  4. School absences

    Time frame: 15 months

    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.

  5. Asthma knowledge

    Time frame: 15 months

    This scale includes 14 questions about asthma knowledge.

  6. Beliefs About Medicines Questionnaire

    Time frame: 15 months

    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.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

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

Acronym: MAIS

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 24, 2018
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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