Condition category
Respiratory
Date applied
10/05/2012
Date assigned
23/11/2012
Last edited
23/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Asthma is one of the commonest long-term condition affecting children in the UK. South Asian children are more likely to suffer with symptoms and be admitted to hospital, but are less likely to understand their medication or be involved in managing their condition. Although there are many efforts made to improve the wellbeing of children with asthma, these are generally less successful for south Asian children than for white children. Services that have been developed jointly with children and families have been shown to work better by delivering solutions tailored to the needs of the children and their families that are also practical from profesionals’ perspectives.
This study aims to use a collaborative method of designing healthcare interventions to develop an intervention programme for south Asian children with asthma.

Who can participate?
Different people are welcome to participate at different stages of the project initially, with everyone coming together in the final stages. People who fit the following criteria will be eligible to participate:
Children aged 4-12 years old who have asthma, from either South Asian or White British backgrounds, parents and extended family members of children with asthma, South Asian adults aged 18yrs upwards, with or without asthma, healthcare professionals who have a role in managing asthma in children or in running children’s services are also eligible.

What does the study involve?
This study has several sections spread over 2 years, including:
Focus groups:
There are usually about 6 to 10 people in a group and they take around 1 hour. The groups will discuss asthma and will be held in community centres or health centres around Leicester. They will be run in several different languages at different times of day.
Interviews:
At an interview you will asked to talk about your experiences of having asthma, having a child with asthma, or working with children with asthma. The interviews usually take around 1 1/2 hours, at a time and day to suit you. Interpreters will be available. Usually, we will interview one parent and then one child, and sometimes a grandparent or the other parent. This will usually happen on the same day at the same place, one after the other. We can also do a joint family interview if people feel more comfortable.
Workshops:
At the first workshop, we will go through the results so far and work in small groups to develop ideas and suggestions to help children with asthma. At the second workshop, we’ll perfect the ideas and turn them into to workable plans to be used in Leicester. Each workshop will take approximately 2 hours in total and parts of it will be recorded. They’ll be in health centres or community centres or at the Universities. We’ll arrange the days and times to be convenient to everyone, will provide refreshments and will have translators available.
Results meetings
These short meetings will be held towards the end of the project to let everyone know the results of the study. There will be options for you to get involved in presenting the results, but you can also just come and listen if you prefer.
Evaluation Interviews (Talking to us about your experience of taking part)
At the end of the study, we might ask you to tell us about your experience in taking part in this study. This will be a very short (10 minute) interview, usually over the phone.

What are the possible benefits and risks of participating?
We hope that the information we get from this study will help improve the lives of children with asthma.
Taking part will take up your time.

Where is the study run from?
The University of Leicester is running the study, supported by De Montfort University, Leicester Partnership Trust and University Hospitals Leicester NHS Trust.

When is study starting and how long is it expected to run for?
The study starts in September 2010 and will run for about 18 months, finishing in February 2013.

Who is funding the study?
The money for the study has come from the National Institute of Health Research - Health Services Research Programme.

Who is the main contact?
Dr Deborah Bird
db230@le.ac.uk

Trial website

http://www.heradu.org/mia

Contact information

Type

Scientific

Primary contact

Dr Deborah Bird

ORCID ID

Contact details

Department of Child Health
Level 5
RKCSB Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8591

Study information

Scientific title

MIA - Management and Interventions for Asthma: Development of a coproduced, multifaceted intervention to optimise asthma management, tailored to the needs of children of South Asian origin

Acronym

MIA

Study hypothesis

The research design consists of three linked phases of data collection and analysis, a fourth phase of collaborative workshops to design the intervention, integral to which is assessment of feasibility and acceptability, followed by a final phase of evaluation of the study methodology.

Phase 1 – Evidence synthesis
The purpose of the Evidence Synthesis is to inform subsequent phases of the study by systematically and critically reviewing existing literature on existing interventions for asthma management in south Asian children and families and the barriers and facilitators to asthma management in south Asian children.

Phase 2 – Community Study
We will use focus groups and semi-structured interviews to assess lay perceptions of asthma and the impact of cultural, religious and wider social-environmental influences on children’s health and asthma in particular. This will provide an understanding of the ways in which families of children with asthma are perceived and treated by the extended family and wider community.

Phase 3 – Families’ and Healthcare professionals study
We will use semi-structured interviews to assess the perceptions of the children and their families and the professionals involved in their care. This will allow an understanding of the experience of being a child with asthma or having a child with asthma, particularly the barriers that are faced, as well as the professional context in which asthma management occurs and health professionals perceptions of the barriers to optimal asthma management.

Phase 4 – Collaborative Intervention Development
This phase will bring together the information from phases 1-3 and enable collaboration between families, community members and healthcare professionals to develop, refine and disseminate interventions.

Phase 5 - Evaluation of Collaboratory Methodology
We will assess this methodology against the achievement of the study objectives and using interviews with study participants.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=8591

Ethics approval

Derbyshire Regional Ethics Committee,10th December 2009, ref: 09/H0401/85

Study design

Community-based participatory research utilising qualitative data collection methods

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Patient information material can be found at http://www.heradu.org/mia/data/english/pdf/71828_MIA_PDFs_English_27082010v2.pdf

Condition

Asthma

Intervention

Families Interviews, Up to 70 Semi-structured interviews (from 30 families) involving up to 30 South Asian children with asthma, 30 Primary carers and 10 grandparent/secondary carers.

Focus Groups, Up to eight focus groups with 6-10 adults from the four main South Asian communities, divided by gender where appropriate and conducted in South Asian languages and English.

Health Professional Interviews, Up to 10 Semi-structured interviews with healthcare professionals with a role in the provision of asthma services for South Asian children.

Key Informant Interviews, Up to 10 semi-structured interviews with key informants from the four main south Asian communities.

Workshops, Series of stakeholder workshops to design and refine a multifaceted intervention programme for asthma management in South Asian children.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To test a participatory model of healthcare intervention development

Secondary outcome measures

1. To produce a realistic and achievable intervention plan for asthma management
2. To provide evidence based understanding of asthma and its management in South Asian children

Overall trial start date

01/09/2010

Overall trial end date

28/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Phase 2:
1. Adults aged 18+
2. South Asian descent

Phase 3:
Children
1. Child has at least one parent of south Asian descent
2. Child with doctor diagnosed asthma
3. Child aged 4-12 years (primary school aged)

Adults:
1. Parent (or carer in absence of parents) of a child fulfilling the inclusion criteria
2. Being a grandparent or secondary carer of a child fulfilling the inclusion criteria

Healthcare Professionals
Currently involved in the provision of services for children of south Asian origin, either directly or in commissioning

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 138; UK Sample Size: 138

Participant exclusion criteria

Phase 2: Does not meet inclusion criteria

Phase 3:
Children:
Co-existing respiratory disorder, e.g. Chronic Lung Disease, Long term ventilation

Adults:
Does not meet inclusion criteria

Healthcare Professionals:
Does not meet inclusion criteria

Recruitment start date

01/09/2010

Recruitment end date

28/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Child Health
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

University of Leicester (UK)

Sponsor details

Department of Health Sciences
22-28 Princess Road West
Leicester
LE1 6TP
United Kingdom
fjm11@le.ac.uk

Sponsor type

University/education

Website

http://www.le.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Services Research (UK) Grant Codes: 09/2001/19

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes