Improving Quality of Life for Teenagers With Asthma

NCT06851715 | Recruiting

• 2 other identifiers: RHM CHI1258349662
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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. 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. 2.Teenager will have their usual consultation with the HCP.

Conditions

Asthma in Children; Asthma

Keywords

Asthma; Adolescent; Self-efficacy; Quality of life; Asthma control

Outcome Measures

Primary Outcomes (1)

• Paediatric Asthma Quality of Life Questionnaire (PAQLQ)

  Paediatric Asthma Quality of Life Questionnaire score ranging from 0-36 points, with a higher score indicating worse quality of life.

  3 months after enrolment

Secondary Outcomes (3)

• Asthma-related healthcare utilisation

  3 months after enrolment

• Asthma Control Test (ACT)

  3 months after enrolment

• Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)

  3 months after enrolment

Study Arms (2)

Clinic consultation focused on asthma self-management

EXPERIMENTAL

The participant will complete the Adolescent Asthma Self-efficacy Questionnaire (AASEQ), and the clinic healthcare professional will use the responses to focus the consultation on areas where the participant needs support for asthma self-management.

Other: Clinic consultation focused on asthma self-management

Usual clinic consultation

NO INTERVENTION

The participant will not complete the AASEQ at baseline and their healthcare professional will conduct the consultation as per usual management.

Interventions

Clinic consultation focused on asthma self-management OTHER

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.

Clinic consultation focused on asthma self-management

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (2)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6Y, United Kingdom

RECRUITING

Isle of Wight NHS Trust, St Mary's Hospital

Isle of Wight, Isle of Wight, PO30 5TG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Anna Rattu

  University of Southampton

  STUDY DIRECTOR

Central Study Contacts

Anna Rattu

CONTACT

+44 (0)23 8059 6835; a.s.rattu@soton.ac.uk

Graham Roberts

CONTACT

+44 (0)23 8059 8138; g.c.roberts@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)