Clinical trial NCT06851715: Improving Quality of Life for Teenagers with Asthma
Official title: Can the Quality of Life of Adolescents with Asthma Be Improved by Focusing on Improving Their Asthma Self-management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma in Children
Asthma
Keywords: Asthma
Adolescent
Self-efficacy
Quality of life
Asthma control
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 76
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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)
* Adolescent or parent/guardian unable to communicate sufficiently to complete consent forms.

Primary outcomes:
measure: Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
timeFrame: 3 months after enrolment
Secondary outcomes:
measure: Asthma-related healthcare utilisation
timeFrame: 3 months after enrolment
measure: Asthma Control Test (ACT)
timeFrame: 3 months after enrolment
measure: Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)
timeFrame: 3 months after enrolment
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Isle of Wight
country: United Kingdom
facility: Isle of Wight NHS Trust, St Mary's Hospital
Study officials:
affiliation: University of Southampton
name: Anna Rattu
role: STUDY_DIRECTOR
References: