Adolescent Behavior, Asthma
Conditions
Brief summary
This trial will address the impaired quality of life of young people with asthma, despite appropriate medicines. Research shows that young people report needing to calm themselves down during an asthma attack to control their breathing. Although physiotherapist- delivered breathing retraining programmes now have a clear evidence base in adults with asthma, improving quality of life, there is a lack of evidence assessing its use in younger patients. The investigators have redesigned an adult training package to make it appropriate for young people and will now assess how effective such an intervention would be in this population. This study will include young people (12-17 years) with physician diagnosed asthma. The repurposing, optimisation and acceptability of the intervention in the adolescent age group has been undertaken in Stages 1 and 2 of the Breathe 4 Teens (BREATHE4T) project. A self-guided, breathing retraining digital intervention has been developed, delivered via a mobile friendly, online platform. The current study is a randomised, controlled feasibility trial and will provide the necessary information for a substantive cost-effectiveness trial. Participants with access to the intervention will be compared to a usual care group. Asthma and quality of life of both groups will also be assessed at baseline, 2-month and 6-month time points. At the end of the 6 months, the control group will also be given access to the website. The online nature of this study allows recruitment from across the United Kingdom. Recruitment methods would include primary care, hospital clinics, social media and posters. AsthmaUK will also provide publicity to assist recruitment.
Detailed description
The trial will aim to assess the acceptability, uptake and success in collecting follow up data and variance in asthma-related outcome measures. A parallel group design will be used with participants being randomised to intervention or normal management. The intervention will be a self-guided, breathing retraining digital intervention, delivered via a mobile-friendly, online platform. The intervention will continue to be used for 6 months after which both groups will be reassessed. The usual management control group will then have access to the intervention (delayed access).
Interventions
BEHAVIORALBreathe for Teens (Breathe4T)
A digital, self-management intervention for adolescents to control their asthma using breathing retraining. The mobile-friendly website provides information about asthma, how it affects the lungs, and how breathing patterns can be dysfunctional. Information is presented using short (30sec-2min) video clips featuring physiotherapists, researchers and adolescent role models. Users are given tips about their practice, including choosing a suitable time and place and building up gradually. Users can plan and log their practice and record their confidence in using the breathing techniques. There are 8 sessions including peer-led videos demonstrating breathing exercises with voiceovers and step-by-step instructions. All features and sessions can be accessed via a main dashboard where users can tailor the intervention to allow parental involvement, reminders and a preferred format for notifications (email/text). Other features include frequently asked questions (FAQs) and a progress chart.
Sponsors
University of Bath
Aston University
University Hospital Southampton NHS Foundation Trust
Asthma UK
University of Southampton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Young people aged 12-17 years * Physician diagnosed asthma * Impaired quality of life (\<85) * Under the care of a general practitioner, community or hospital practitioner for their asthma
Exclusion criteria
* Co-existent respiratory conditions such as bronchiectasis * Already using breathing techniques * Already enrolled in another interventional study * Lack of informed consent * Learning difficulties * Previously involved with Stages 1 and 2 of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma-specific Quality of Life | 6 months | PedsQL (paediatric quality of life inventory) - asthma module - presented as a total score with a higher score indicating lower problems, and therefore better quality of life. Min 0 - Max 100. Scale scores are computed as the sum of the items over the number of items answered. |
| Asthma Control | 6 months | Asthma control test (ACT) - presented as a total score with a lower score indicating poor control. Overall score above 19 would indicate well-controlled asthma. Min value 0 - Max 25. |
| Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | 6 months | Self-reported in a healthcare utilisation questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attendance at Emergency Department for an Exacerbation of Asthma | 6 months | Self-reported in a healthcare utilisation questionnaire |
| Hospital Admission for an Exacerbation of Asthma | 6 months | Self-reported in a healthcare utilisation questionnaire |
| Paediatric Quality of Life | 6 months | Paediatric asthma quality life questionnaire (PAQLQ) - presented as a total score. Higher scores represent a better quality of life. Min value 1 - max 7. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Access to digital intervention
Breathe4T: A digital, self-management intervention for adolescents to control their asthma using breathing retraining. The mobile-friendly website provides information about asthma and how it affects the lungs, as well as how breathing patterns can be dysfunctional. Information is presented using short (30sec-2min) video clips featuring physiotherapists, researchers and adolescent role models. Users are given tips about their practice, including choosing a suitable time and place and building up gradually. Users can plan their practice, log how their practice went and record their confidence in using the breathing techniques. There are 8 sessions including peer-led videos demonstrating breathing exercises with voiceovers and step-by-step instructions. All features and sessions can be accessed via a main dashboard where users can tailor the intervention to allow parental involvement, reminders and a preferred format for notifications (email/text). Other features include FAQs and a progress chart. | 32 |
| Control Group Usual care group | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Customized Age (years) 12-14 | 13 Participants | 16 Participants | 29 Participants |
| Age, Customized Age (years) 15-17 | 19 Participants | 16 Participants | 35 Participants |
| Attended accident and emergency (A&E) in past year No | 27 Participants | 28 Participants | 55 Participants |
| Attended accident and emergency (A&E) in past year Yes | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity White/English/Scottish/Welsh | 29 Participants | 30 Participants | 59 Participants |
| Race/Ethnicity, Customized Ethnicity White other | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United Kingdom | 32 Participants | 32 Participants | 64 Participants |
| Sex/Gender, Customized Gender Female | 23 Participants | 18 Participants | 41 Participants |
| Sex/Gender, Customized Gender Male | 8 Participants | 12 Participants | 20 Participants |
| Sex/Gender, Customized Gender Prefer not to say / unknown | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Asthma Control
Asthma control test (ACT) - presented as a total score with a lower score indicating poor control. Overall score above 19 would indicate well-controlled asthma. Min value 0 - Max 25.
Time frame: 6 months
Population: Number analysed is different between baseline and 6 months due to loss to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Asthma Control | Baseline | 17.2 score on a scale | Standard Deviation 5.2 |
| Intervention Group | Asthma Control | 6 months | 16.9 score on a scale | Standard Deviation 4.1 |
| Control Group | Asthma Control | Baseline | 17.4 score on a scale | Standard Deviation 4.5 |
| Control Group | Asthma Control | 6 months | 17.8 score on a scale | Standard Deviation 5.2 |
Primary
Asthma-specific Quality of Life
PedsQL (paediatric quality of life inventory) - asthma module - presented as a total score with a higher score indicating lower problems, and therefore better quality of life. Min 0 - Max 100. Scale scores are computed as the sum of the items over the number of items answered.
Time frame: 6 months
Population: Number analysed at 6 months is less than baseline due to loss at follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Asthma-specific Quality of Life | Baseline | 65.4 score on a scale | Standard Deviation 13.2 |
| Intervention Group | Asthma-specific Quality of Life | 6 months | 66.7 score on a scale | Standard Deviation 11.3 |
| Control Group | Asthma-specific Quality of Life | Baseline | 65.1 score on a scale | Standard Deviation 15.6 |
| Control Group | Asthma-specific Quality of Life | 6 months | 67.4 score on a scale | Standard Deviation 18.1 |
Primary
Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar)
Self-reported in a healthcare utilisation questionnaire.
Time frame: 6 months
Population: number analysed at 6 months is less than baseline due to loss to follow-up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Group | Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | Baseline | Yes | 9 Participants |
| Intervention Group | Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | Baseline | No | 23 Participants |
| Intervention Group | Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | 6 months | Yes | 5 Participants |
| Intervention Group | Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | 6 months | No | 13 Participants |
| Control Group | Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | 6 months | No | 16 Participants |
| Control Group | Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | Baseline | Yes | 11 Participants |
| Control Group | Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | 6 months | Yes | 6 Participants |
| Control Group | Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | Baseline | No | 21 Participants |
Secondary
Attendance at Emergency Department for an Exacerbation of Asthma
Self-reported in a healthcare utilisation questionnaire
Time frame: 6 months
Population: Number analysed differs from baseline to 6 months due to loss to follow-up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Group | Attendance at Emergency Department for an Exacerbation of Asthma | Baseline | yes | 5 Participants |
| Intervention Group | Attendance at Emergency Department for an Exacerbation of Asthma | Baseline | no | 27 Participants |
| Intervention Group | Attendance at Emergency Department for an Exacerbation of Asthma | 6 months | yes | 0 Participants |
| Intervention Group | Attendance at Emergency Department for an Exacerbation of Asthma | 6 months | no | 18 Participants |
| Control Group | Attendance at Emergency Department for an Exacerbation of Asthma | 6 months | no | 20 Participants |
| Control Group | Attendance at Emergency Department for an Exacerbation of Asthma | Baseline | yes | 4 Participants |
| Control Group | Attendance at Emergency Department for an Exacerbation of Asthma | 6 months | yes | 2 Participants |
| Control Group | Attendance at Emergency Department for an Exacerbation of Asthma | Baseline | no | 28 Participants |
Secondary
Hospital Admission for an Exacerbation of Asthma
Self-reported in a healthcare utilisation questionnaire
Time frame: 6 months
Population: Number analysed differs due to loss to follow-up at 6 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Group | Hospital Admission for an Exacerbation of Asthma | Baseline | yes | 14 Participants |
| Intervention Group | Hospital Admission for an Exacerbation of Asthma | Baseline | no | 18 Participants |
| Intervention Group | Hospital Admission for an Exacerbation of Asthma | 6 months | yes | 0 Participants |
| Intervention Group | Hospital Admission for an Exacerbation of Asthma | 6 months | no | 18 Participants |
| Control Group | Hospital Admission for an Exacerbation of Asthma | 6 months | no | 20 Participants |
| Control Group | Hospital Admission for an Exacerbation of Asthma | Baseline | yes | 17 Participants |
| Control Group | Hospital Admission for an Exacerbation of Asthma | 6 months | yes | 2 Participants |
| Control Group | Hospital Admission for an Exacerbation of Asthma | Baseline | no | 15 Participants |
Secondary
Paediatric Quality of Life
Paediatric asthma quality life questionnaire (PAQLQ) - presented as a total score. Higher scores represent a better quality of life. Min value 1 - max 7.
Time frame: 6 months
Population: Number analysed at 6 months in less than baseline due to loss at follow-up. Key finding of feasibility trial that burden of this additional paper questionnaire was not feasible.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Paediatric Quality of Life | Baseline | 4.5 score on a scale | Standard Deviation 1.6 |
| Intervention Group | Paediatric Quality of Life | 6 months | 5.7 score on a scale | Standard Deviation 0.7 |
| Control Group | Paediatric Quality of Life | Baseline | 5.1 score on a scale | Standard Deviation 1.5 |
| Control Group | Paediatric Quality of Life | 6 months | 4.6 score on a scale | Standard Deviation 1.5 |