NCT06681545

Brief 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. 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

November 25, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

October 22, 2024

Last Update Submit

February 3, 2025

Conditions

Keywords

young peopleyoung adultsyoung person

Outcome Measures

Primary Outcomes (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.

    12 months

Other Outcomes (1)

  • patient perceived support needs

    12 months

Study Arms (1)

young adults with severe and or uncontrolled asthma

no intervention to be administered. Participants will be asked to participate in 1-1 interviews and or focus group interviews

Other: one to one interviews and or focus groups

Interventions

one to one interviews and or focus groups

young adults with severe and or uncontrolled asthma

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

young adults age 16-25 with severe or uncontrolled asthma

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severe asthma services based at both Manchester University Foundation NHS trust and Liverpool University Foundation NHS Trust

Manchester, Greater, M239LT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Leanne - Jo Holmes, Mres

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2024

First Posted

November 8, 2024

Study Start

November 25, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations