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

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ClinicalTrials.gov Identifier: NCT03536416
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan Grigg, Queen Mary University of London

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: My Asthma in School Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Masking Description: The schools will be randomised, and will not be told which group they have been randomised to.
Primary Purpose: Other
Official Title: Multifaceted Theory-based Self-management Intervention to Improve Adolescents' Asthma Control: A Cluster-randomised Controlled Trial (RCT)
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: Theatre only group
My Asthma in School. This group will receive the theatre performance only.
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.

No Intervention: Control group
My Asthma in School. The control group will receive usual care for the duration of the intervention.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536416


Contacts
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Contact: Professor Grigg 020 7882 2206 j.grigg@qmul.ac.uk
Contact: Katherine Harris 020 7882 2361 k.harris@qmul.ac.uk

Locations
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United Kingdom
Queen Mary University of London Recruiting
London, United Kingdom, E1 2AT
Contact: Dr Grigg    020 7882 2206    j.grigg@qmul.ac.uk   
Contact: Katherine Harris    020 7882 2361    k.harris@qmul.ac.uk   
Sub-Investigator: Professor Bonell         
Sub-Investigator: Professor Griffiths         
Sub-Investigator: Dr Steed         
Sub-Investigator: Katherine Harris         
Sub-Investigator: Dr Mosler         
Sponsors and Collaborators
Queen Mary University of London
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Responsible Party: Jonathan Grigg, Professor, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03536416    
Other Study ID Numbers: MGU0400
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Grigg, Queen Mary University of London:
Self-management
Children and young people
Schools
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases