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Recruiting NCT06851715

Improving Quality of Life for Teenagers With Asthma

No phase Interventional Asthma in Children Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinic consultation focused on asthma self-management.
Who it may be relevant to
Registry conditions: Asthma in Children, Asthma. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Can the Quality of Life of Adolescents With Asthma be Improved by Focusing on Improving Their Asthma Self-management

Overview

BACKGROUND: Asthma is a long-term lung condition affecting 1 in 11 children and young people in the UK. Many teenagers have well controlled asthma, but a significant number continue to experience regular symptoms and asthma attacks leading to hospitalisations. While non-adherence to medication is a factor, teenagers also face challenges like changing relationships with parents and peers, avoiding triggers like smoking, and fitting in treatment with daily life demands. Healthcare professionals (HCPs) also face difficulties in managing teenagers with asthma. A previous study, funded by Asthma + Lung UK, developed a new approach to manage teenage asthma by focusing on self-efficacy, which is how confident one feels about performing a task. Teenagers completed the Adolescent Asthma Self-Efficacy Questionnaire (AASEQ), which identified areas where they needed more support. HCPs then tailored their consultations to address these needs. This approach improved the teenagers' confidence in self-managing their asthma. Improving quality of life (QoL) is a key goal in asthma care. Therefore, the aim of this study is to determine if the self-efficacy approach improves QoL for teenagers with asthma. METHODS: Teenagers aged 12-18 years with asthma will be recruited from hospital clinics. They will be randomly assigned to one of two groups: 1. Teenager will complete the AASEQ at the start of their appointment. The HCPs will use this to focus the consultation on areas where the teenager needs support in self-managing their asthma. 2. Teenager will have their usual consultation with the HCP. Three months after the appointment, the QoL will be compared between the two groups using a standardised questionnaire. IMPACT: If the self-efficacy approach proves to be beneficial, it could help HCPs to empower teenagers to better manage their asthma and ultimately improve their quality of life.

Interventions

  • Other Clinic consultation focused on asthma self-management
    The clinic healthcare professionals (HCPs) will be provided with the completed Adolescent Asthma Self-efficacy Questionnaire (AASEQ), which will help identify areas where participants need additional support to improve their asthma self-management skills. Targeted behavioural interventions, developed during the 'ItsMyAsthma' study, will be applied during the clinic consultation to address individual needs.

Primary outcome measures

  • Paediatric Asthma Quality of Life Questionnaire (PAQLQ) [Time frame: 3 months after enrolment]
Secondary outcome measures (3)
  • Asthma-related healthcare utilisation [Time frame: 3 months after enrolment]
  • Asthma Control Test (ACT) [Time frame: 3 months after enrolment]
  • Adolescent Asthma Self-Efficacy Questionnaire (AASEQ) [Time frame: 3 months after enrolment]

Eligibility criteria

Inclusion criteria

  • Adolescent aged 12-18 years
  • Attending a paediatric respiratory clinic
  • Informed consent from adolescent aged ≥16 years, and assent plus parent/guardian consent for adolescents aged ≤16 years
  • Paediatric Asthma Quality of Life Questionnaire score ≤5.5 points

Exclusion criteria

  • Aged 0-11 or over 18 years
  • Other significant long-term medical condition that has a day-to-day impact on their lives (except for co-existing allergic conditions, breathing pattern disorder, dysfunctional breathing, or intermittent laryngeal obstruction)
  • Adolescent or parent/guardian unable to communicate sufficiently to complete consent forms.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United Kingdom · 2 centers
  • University Hospital Southampton NHS Foundation Trust — Southampton
  • Isle of Wight NHS Trust, St Mary's Hospital — Isle of Wight

Identifiers

NCT: NCT06851715 · RHM CHI1258 · 349662

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗