- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06851715
Improving Quality of Life for Teenagers With Asthma (IMPAQT)
Can the Quality of Life of Adolescents With Asthma be Improved by Focusing on Improving Their Asthma Self-management
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:
- 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.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Rattu
- Phone Number: +44 (0)23 8059 6835
- Email: a.s.rattu@soton.ac.uk
Study Contact Backup
- Name: Graham Roberts
- Phone Number: +44 (0)23 8059 8138
- Email: g.c.roberts@soton.ac.uk
Study Locations
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom, SO16 6Y
- Recruiting
- University Hospital Southampton NHS Foundation Trust
-
Contact:
- Graham Roberts
- Phone Number: +44 (0)23 8059 8138
- Email: g.c.roberts@soton.ac.uk
-
-
Isle of Wight
-
Isle of Wight, Isle of Wight, United Kingdom, PO30 5TG
- Recruiting
- Isle of Wight NHS Trust, St Mary's Hospital
-
Contact:
- Graham Roberts
- Phone Number: +44 (0)23 8059 8138
- Email: g.c.roberts@soton.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clinic consultation focused on asthma self-management
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.
|
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.
|
|
No Intervention: Usual clinic consultation
The participant will not complete the AASEQ at baseline and their healthcare professional will conduct the consultation as per usual management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time Frame: 3 months after enrolment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma-related healthcare utilisation
Time Frame: 3 months after enrolment
|
Asthma-related healthcare utilisation including number of asthma exacerbations requiring prednisolone/dexamethasone, and/or GP visits, Emergency Department, Hospital, or Intensive care admissions.
|
3 months after enrolment
|
|
Asthma Control Test (ACT)
Time Frame: 3 months after enrolment
|
Asthma Control Test score ranging from 5-25 points, with a higher score indicating better asthma control.
|
3 months after enrolment
|
|
Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)
Time Frame: 3 months after enrolment
|
Adolescent Asthma Self Efficacy Questionnaire score ranging from 0-100 points, with a higher score indicating greater self-efficacy for management of asthma.
|
3 months after enrolment
|
Collaborators and Investigators
Investigators
- Study Director: Anna Rattu, University of Southampton
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHM CHI1258
- 349662 (Other Identifier: Integrated Research Approval System (IRAS))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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