Trial Outcomes & Findings for Breathing Retraining for Asthma Trial of Home Exercises for Teenagers (NCT NCT05006703)
NCT ID: NCT05006703
Last Updated: 2024-10-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
6 months
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
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.
|
Control Group
Usual care group
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
18
|
27
|
|
Overall Study
NOT COMPLETED
|
14
|
5
|
Reasons for withdrawal
| Measure |
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.
|
Control Group
Usual care group
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
13
|
5
|
Baseline Characteristics
Breathing Retraining for Asthma Trial of Home Exercises for Teenagers
Baseline characteristics by cohort
| Measure |
Intervention Group
n=32 Participants
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.
|
Control Group
n=32 Participants
Usual care group
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (years) · 12-14
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Customized
Age (years) · 15-17
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Prefer not to say / unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White/English/Scottish/Welsh
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Attended accident and emergency (A&E) in past year
No
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Attended accident and emergency (A&E) in past year
Yes
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Number analysed at 6 months is less than baseline due to loss at follow-up.
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.
Outcome measures
| Measure |
Intervention Group
n=32 Participants
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.
|
Control Group
n=32 Participants
Usual care group
|
|---|---|---|
|
Asthma-specific Quality of Life
Baseline
|
65.4 score on a scale
Standard Deviation 13.2
|
65.1 score on a scale
Standard Deviation 15.6
|
|
Asthma-specific Quality of Life
6 months
|
66.7 score on a scale
Standard Deviation 11.3
|
67.4 score on a scale
Standard Deviation 18.1
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Number analysed is different between baseline and 6 months due to loss to follow-up.
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.
Outcome measures
| Measure |
Intervention Group
n=32 Participants
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.
|
Control Group
n=32 Participants
Usual care group
|
|---|---|---|
|
Asthma Control
Baseline
|
17.2 score on a scale
Standard Deviation 5.2
|
17.4 score on a scale
Standard Deviation 4.5
|
|
Asthma Control
6 months
|
16.9 score on a scale
Standard Deviation 4.1
|
17.8 score on a scale
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: number analysed at 6 months is less than baseline due to loss to follow-up
Self-reported in a healthcare utilisation questionnaire.
Outcome measures
| Measure |
Intervention Group
n=32 Participants
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.
|
Control Group
n=32 Participants
Usual care group
|
|---|---|---|
|
Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar)
Baseline · Yes
|
9 Participants
|
11 Participants
|
|
Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar)
Baseline · No
|
23 Participants
|
21 Participants
|
|
Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar)
6 months · Yes
|
5 Participants
|
6 Participants
|
|
Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar)
6 months · No
|
13 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number analysed differs from baseline to 6 months due to loss to follow-up
Self-reported in a healthcare utilisation questionnaire
Outcome measures
| Measure |
Intervention Group
n=32 Participants
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.
|
Control Group
n=32 Participants
Usual care group
|
|---|---|---|
|
Attendance at Emergency Department for an Exacerbation of Asthma
Baseline · yes
|
5 Participants
|
4 Participants
|
|
Attendance at Emergency Department for an Exacerbation of Asthma
Baseline · no
|
27 Participants
|
28 Participants
|
|
Attendance at Emergency Department for an Exacerbation of Asthma
6 months · yes
|
0 Participants
|
2 Participants
|
|
Attendance at Emergency Department for an Exacerbation of Asthma
6 months · no
|
18 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number analysed differs due to loss to follow-up at 6 months
Self-reported in a healthcare utilisation questionnaire
Outcome measures
| Measure |
Intervention Group
n=32 Participants
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.
|
Control Group
n=32 Participants
Usual care group
|
|---|---|---|
|
Hospital Admission for an Exacerbation of Asthma
Baseline · yes
|
14 Participants
|
17 Participants
|
|
Hospital Admission for an Exacerbation of Asthma
Baseline · no
|
18 Participants
|
15 Participants
|
|
Hospital Admission for an Exacerbation of Asthma
6 months · yes
|
0 Participants
|
2 Participants
|
|
Hospital Admission for an Exacerbation of Asthma
6 months · no
|
18 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Paediatric asthma quality life questionnaire (PAQLQ) - presented as a total score. Higher scores represent a better quality of life. Min value 1 - max 7.
Outcome measures
| Measure |
Intervention Group
n=32 Participants
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.
|
Control Group
n=32 Participants
Usual care group
|
|---|---|---|
|
Paediatric Quality of Life
Baseline
|
4.5 score on a scale
Standard Deviation 1.6
|
5.1 score on a scale
Standard Deviation 1.5
|
|
Paediatric Quality of Life
6 months
|
5.7 score on a scale
Standard Deviation 0.7
|
4.6 score on a scale
Standard Deviation 1.5
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Graham Roberts
University Hospital Southampton
Phone: 02381 204335
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place