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AsthmaEaSYNCT06681545

Exploring the Lived Experience of Young Adults With Severe Asthma

An observational study of Asthma and Severe Asthma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Asthma is a serious long-term lung condition caused by swollen airways that narrow. This causes wheezing, chest tightness, and breathlessness. Most asthma is well-controlled with medication. Read more about this study

Who is it for?
Ages 16 to 25 years
Conditions the study is for
Asthma, Severe Asthma, Uncontrolled Asthma
What is being tested?
one to one interviews and or focus groups
How many people
46 participants
Where
1 siteUnited Kingdom
Study dates
25 Nov 2024to 31 Oct 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: young adults age 16-25 with severe or uncontrolled asthma

Who may be able to join

  • A confirmed diagnosis of severe or uncontrolled asthma under the care of the Manchester or Liverpool severe asthma services
  • Participants aged 16-25 years.
  • Informed consent provided.

Who cannot join

  • Inability to provide informed consent.
  • Participants with additional long-term conditions who identify their dominant health concern to be non-asthma related.
  • Focus group only- inability to converse in English

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting
  • Severe asthma services based at both Manchester University Foundation NHS trust and Liverpool University Foundation NHS Trust

    Manchester, Greater, M239LT

    Leanne J Holmes, Masters in reserach, 4401619987070 ext. 2311, leannejo.holmes@mft.nhs.uk

    Leanne J Holmes, Masters in research

    Recruiting

Other trials in United Kingdom

About this study

Official title: An Exploration of the Experiences and Support Needs of Young Adults With Severe and Uncontrolled Asthma

Asthma is a serious long-term lung condition caused by swollen airways that narrow. This causes wheezing, chest tightness, and breathlessness. Most asthma is well-controlled with medication.

However, 5-10% of asthmatics have severe asthma where treatment does not control symptoms and up to 67% of asthmatics have uncontrolled asthma, caused by not always taking medication as recommended, lifestyle choices or other health problems worsening their asthma.

Read more

In the UK, asthma affects around 800,000 young adults. This group is at high-risk of having poor asthma control, worse outcomes than other age-groups. This is because young adults need care that differs from other age-groups and current care is not meeting these needs.

There is little information on the experiences and needs of this group and very few studies exist, exploring how to improve care. This study will explore the experiences and needs of young adults (age16-25) with severe and uncontrolled asthma.

Methods. The investigators will perform two study-arms with young adults with severe/uncontrolled asthma in Manchester and Liverpool severe asthma centres:

Study-arm 1: Interview participants using photographs chosen by them to help explain their experiences of living with asthma and support that they need.

Study arm 2: Perform group interviews to understand participants' thoughts around the insights from study-arm 1 combined with their own experiences. To explore and develop ideas on how to improve future care.

At the end of both study arms, a workshop involving patients and stakeholders involved in delivering care will take place, to identify a joint goal of how to improve care in this cohort and map ways in which to achieve this.

Together, the study results and workshop will increase our understanding of the experiences and needs of young adults with asthma. Helping us to identify new ways to improve care which can be tested in future research.

Read the detailed description

Research question "What are the experiences, and support needs of young adults living with severe and uncontrolled asthma?"

Aim To develop a rich in-depth understanding of the lived experiences, challenges, and perceived support needs of being a young adult with severe and or uncontrolled asthma.

Objectives

  1. Examine in -depth the day-to-day experiences of living with severe asthma through undertaking 1-1 in-depth interviews using photo elicitation techniques.
  2. Identify participant support needs through undertaking focus groups
  3. Combine results from 1-1 and focus group interviews, to help inform and develop future interventions/research.
  4. To develop a theory of change with patients and stakeholders.

Study design A qualitative design using photo elicitation driven semi-structured one-to-one interviews (work package 1) followed by focus group interviews, (work package 2) concluding with a Theory of Change (TOC) workshop.

Data collection Work package 1: In-depth interviews - Post consent participants will be asked to select/take and bring between 3-5 pictures or self-taken photographs to the 1-1 interview to help them describe their experiences of living with asthma to the interview. The interviews will be conducted using a pre-designed semi-structured interview schedule and the participant's selected images to guide the interview. Interviews can be either face-to-face in person or online via MS subject to participant choice. The interviews will be audio recorded and uploaded post interview.

Demographic details (age, gender, ethnicity, and educational attainment) and medical history will be obtained from within the medical records, by the PI including Asthma Phenotype, Medication use, Lung function/FeNO and recent ACQ/AQLQ questionnaire results and completed onto a Case report form.

Work package 2: Focus groups - There will be two separate focus groups of between 4-8 participants. They will be face-to-face with the focus groups being led by the PI and supported by a PPIE engagement officer. The focus groups will be audio recorded on an encrypted dictaphone for future transcription. The focus groups will start with a summary of the results derived from the1-1 interviews and a synopsis of previous interventions to date in other research. the investigators will ask participants to consider their own support needs and to provide suggestions for future care interventions within the focus groups. Participant medical history and demographic details (age gender, ethnicity and educational attainment) will be obtained from within the medical notes by the PI.

A TOC workshop will assemble patients and stakeholders involved in the receipt and delivery of care of young adults with severe and uncontrolled asthma and will be facilitated to develop a 'theory-of-change'. The output of the TOC meeting will be a TOC process map and a detailed report of all discussions.

Statistical analysis Demographic and clinical data will be presented descriptively using appropriate statistics, including mean (standard deviation), median (interquartile range), N (percentage), and graphics.

Qualitative data analysis The in-depth 1-1 interviews will be analysed using interpretive phenomenological analysis, whereas the focus groups will be analysed using thematic analysis.

Research Ethics Committee (REC) Before the start of the study, a favourable opinion will be sought from a REC and HRA for the study protocol, informed consent forms and other relevant patient facing documents.

Patient \& Public Involvement This proposed research has been amended and refined over the last four years with young adults. Within this research the investigators will work with a Patient and Public engagement officer and Patient Advisory Group (PAG) consisting of 3-5 individuals to advise on many elements of the study.

Dissemination On completion of the study a final study report will be prepared. It is also intended to publish the results from both work packages in peer reviewed journal's, be presented at professional conference and submitted as part of a PhD thesis.

A study summary leaflet will be designed for both work packages The thematic content of the in-depth interviews and participant photographs/pictures (Subject to opting in on the consent form) will be developed into a short creative media video, outlining the results in a manner understandable for the lay public. The in-depth interviews and focus groups combined will also be made into a short media illustration to facilitate easy understanding by the lay public.

Being tested
one to one interviews and or focus groups
Keywords
young people, young adults, young person
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • one to one interviews and or focus groupsOther

    one to one interviews and or focus groups

Study groups in NCT06681545
Study groupRoleWhat they receive
young adults with severe and or uncontrolled asthmano intervention to be administered. Participants will be asked to participate in 1-1 interviews and or focus group interviews
Receives: Other: one to one interviews and or focus groups

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient perceived experiences and challenges of living with severe and or uncontrolled asthma

    The investigators are not directly using tools/scales to measure outcome measures but will be using the data generated from the in depth interviews and focus groups to understand subjective participant perceived experiences and challenges of living with severe/uncontrolled asthma. in seeking to understand this, the investigators will meet the intended primary outcomes of the study.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start25 Nov 2024
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06681545
Sponsor's protocol ID
B02178
Acronym
EaSY
Status last verified
Feb 2025
First submitted
22 Oct 2024
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Severe Asthma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leanne - Jo Holmes, Mres (+44 01619987070 ext. 2311, leannejo.holmes@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient perceived experiences and challenges of living with severe and or uncontrolled asthma (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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