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| ID | Type | Description | Link |
|---|---|---|---|
| PB-PG-0817-20038 | Other Grant/Funding Number | NIHR RfPB |
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| Name | Class |
|---|---|
| University of Bath | OTHER |
| Aston University | OTHER |
| University Hospital Southampton NHS Foundation Trust | OTHER |
| Asthma UK |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Access to digital intervention |
|
| Control group | No Intervention | Usual care group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathe for Teens (Breathe4T) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 6 months |
| Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | Self-reported in a healthcare utilisation questionnaire. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance at Emergency Department for an Exacerbation of Asthma | Self-reported in a healthcare utilisation questionnaire | 6 months |
| Hospital Admission for an Exacerbation of Asthma | Self-reported in a healthcare utilisation questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graham Roberts | University of Southampton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Southampton | Southampton | Hampshire | SO16 6YD | United Kingdom |
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| Label | URL |
|---|---|
| Study webpage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Access to digital intervention Breathe 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 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 voice overs 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. |
| FG001 | Control Group | Usual care group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number analysed at 6 months is less than baseline due to loss at follow-up. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
6 month trial period
Adverse events are reported for both the intervention and control group during the 6 month trial period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Graham Roberts | University Hospital Southampton | 02381 204335 | g.c.roberts@soton.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2021 | Sep 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
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| OTHER |
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|
| 6 months |
| 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. | 6 months |
| BG001 | Control Group | Usual care group |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Attended accident and emergency (A&E) in past year | Count of Participants | Participants |
|
| OG001 | Control Group | Usual care group |
|
|
| 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. | Number analysed is different between baseline and 6 months due to loss to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Primary | Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar) | Self-reported in a healthcare utilisation questionnaire. | number analysed at 6 months is less than baseline due to loss to follow-up | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Attendance at Emergency Department for an Exacerbation of Asthma | Self-reported in a healthcare utilisation questionnaire | Number analysed differs from baseline to 6 months due to loss to follow-up | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Hospital Admission for an Exacerbation of Asthma | Self-reported in a healthcare utilisation questionnaire | Number analysed differs due to loss to follow-up at 6 months | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Control Group | Usual care group | 0 | 32 | 0 | 32 | 0 | 32 |
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| D008171 |
| Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| 6 months |
|
|
| No |
|
| 6 months |
|
|
| no |
|
| 6 months |
|
|
| no |
|
| 6 months |
|
|
| 6 months |
|
|