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Self-management Intervention to Improve Adolescents' Asthma Control (MAIS)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
My Asthma in School
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Self-management, Children and young people, Schools

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queen Mary University of London

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Asthma workshop and theatre group

Theatre only group

Control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Asthma knowledge
This scale includes 14 questions about asthma knowledge.
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.

Full Information

First Posted
May 14, 2018
Last Updated
November 9, 2022
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT03536416
Brief Title
Self-management Intervention to Improve Adolescents' Asthma Control
Acronym
MAIS
Official Title
Multifaceted Theory-based Self-management Intervention to Improve Adolescents' Asthma Control: A Cluster-randomised Controlled Trial (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Mary University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Self-management, Children and young people, Schools

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The schools will be randomised, and will not be told which group they have been randomised to.
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma workshop and theatre group
Arm Type
Experimental
Arm Description
My Asthma in School. This group will receive the self-management workshops for asthmatic children and the theatre performance for the whole year group.
Arm Title
Theatre only group
Arm Type
Active Comparator
Arm Description
My Asthma in School. This group will receive the theatre performance only.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
My Asthma in School. The control group will receive usual care for the duration of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
My Asthma in School
Intervention Description
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 Outcome Measure Information:
Title
Asthma control
Description
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.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Medication Adherence Rating Scale.
Description
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.
Time Frame
15 months
Title
Unscheduled care
Description
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.
Time Frame
15 months
Title
Brief-Illness Perception Questionnaire
Description
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.
Time Frame
15 months
Title
School absences
Description
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.
Time Frame
15 months
Title
Asthma knowledge
Description
This scale includes 14 questions about asthma knowledge.
Time Frame
15 months
Title
Beliefs About Medicines Questionnaire
Description
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.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Queen Mary University of London
City
London
ZIP/Postal Code
E1 2AT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Overall findings for each school will be reported back to individual schools, however individual participant data will not be reported due to data protection and confidentiality.
Citations:
PubMed Identifier
32884832
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.
Results Reference
background
PubMed Identifier
31015270
Citation
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.
Results Reference
background
PubMed Identifier
29413036
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. No abstract available.
Results Reference
background
PubMed Identifier
35321754
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: 10.1186/s40814-022-01031-1.
Results Reference
result
Links:
URL
https://myhealthinschool.org/
Description
Project website

Learn more about this trial

Self-management Intervention to Improve Adolescents' Asthma Control

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