Asthma (Diagnosis)BRAIDNCT07421115
Multicomponent Breathlessness and Physical Activity Intervention in People With Asthma Using a Digital Platform
A study testing Multicomponent digital self-management platform in people with Asthma (Diagnosis) and Breathlessness, run by University of Newcastle, Australia at 2 sites in Australia.
Trial summary
Treating breathlessness could help people with asthma have fewer symptoms and be more physically active. People with asthma report that it is important to deal with breathlessness during physical activity programs, but past research hasn't focused on this need. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma (Diagnosis), Breathlessness
- What is being tested?
- Multicomponent digital self-management platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Mar 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Able to provide informed consent
- Evidence of variable airflow limitation within the past 10-years to confirm asthma diagnosis
- Meets diagnostic criteria for moderate, or severe asthma
- Reports breathlessness impacting daily life physical activities (modified Medical Research Council [mMRC] dyspnoea score ≥1) within the past 1-week
- Owns a smart device with internet access, which they are willing and able to use for the study duration
Who cannot join
- High dependence on medical care
- Significant life-limiting comorbidity (<12 months life expectancy)
- Cognitive impairment, poor English language skills or significant untreated hearing impairment that prevents completion of data collection forms or understanding of verbal instructions
- Current participation in any other clinical trial, or participation in another clinical trial within the 4-weeks preceding study entry.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
The Prince Charles Hospital
Chermside, Queensland, 4032
Ian Yang, +61 7 3139 5050, Ian.Yang@health.qld.gov.au
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Paola D Urroz Guerrero, +61 2 4042 0092, paola.urroz@newcastle.edu.au
About this study
Official title: Multicomponent Breathlessness and Physical Activity Intervention in People With Moderate to Severe Asthma Using a Supported Digital Platform
Treating breathlessness could help people with asthma have fewer symptoms and be more physically active. People with asthma report that it is important to deal with breathlessness during physical activity programs, but past research hasn't focused on this need.
The investigators have developed a multicomponent digitally supported intervention targeting breathlessness and physical inactivity. This study will test whether the multicomponent digital supported intervention will help people with asthma. The main question the study aims to answer is:
Read more
Does the multicomponent digitally supported intervention improve quality of life?
Participants will:
- Be allocated to the intervention or usual care. Allocation to either group will be random (like tossing a coin).
- Attend study visits to complete an assessment involving questionnaires and measurements
- Receive telephone calls to ask questions about health
- Be invited to take part in an interview to have a conversation about thoughts on participating in the study
- Be asked to provide consent to collect information from Services Australia regarding use of health care services and medications
- Conditions
- Asthma (Diagnosis), Breathlessness
- Being tested
- Multicomponent digital self-management platform, Enhanced usual care
- Medical subject headings
- Asthma, Disease, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent digital self-management platformBehavioural
Attend an in-person session with an respiratory nurse, focused on breathlessness and physical activity self-management; and be provided access to a digital self-management platform
Enhanced usual careOther
Enhanced usual asthma tertiary care
| Study group | Role | What they receive |
|---|---|---|
| Digital self-management platform and enhanced usual care | Experimental | Not described Receives: Behavioral: Multicomponent digital self-management platform; Other: Enhanced usual care |
| Enhanced usual care | Other | Not described Receives: Other: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Quality of Life Questionnaire (AQLQ)
Items are rated on a 7-point Likert scale, with higher scores indicating better quality of life. A mean score across all items equally weighted is reported. The minimal clinically important difference has been estimated to be 0.5 units.
Measured: 6-months
Secondary outcomes (10)
Asthma Control Questionnaire-5 (ACQ-5)
It asks 5 questions about asthma symptoms over the past week. Each question has a score from 0 to 6. The final score is the mean result of the 5 questions. A high ACQ-5 score indicates poorly controlled asthma. A change in ACQ-5 score of 0.5 or more is considered clinically significant.
Measured: 6-months & 12-months
Shortness of Breathlessness with Daily Activities (SOBDA)
The SOBDA is designed to be completed in the evening, recalling that day. Participants are invited to rate how breathlessness they were while performing 13 different daily activities. An average daily score is reported from 4-7 days, with greater scores indicating more severe shortness of breathlessness with daily activities. The minimal clinically important difference estimated to be 0.1-0.2.
Measured: 6-months & 12-month
Multidimensional Dyspnea Profile (MDP)
The MDP comprises 11 items each rated on a 0-10 numeric rating scale, of which five pertain to physical sensory qualities and five emotional responses. The rating of sensory qualities is summed, along with a 0-10 rating of overall unpleasantness (A1), for an Immediate Perception (IP) sub-score. The five emotional response items are summed for an Emotional Response (ER) sub-score. The minimal clinically important difference has been estimated to be 1 for the A1 item, 3 for the Immediate Perception sub-score and 2 for the Emotional Response sub-score. Higher scores on any of the scales indicate greater intensity, unpleasantness, or emotional distress related to breathlessness.
Measured: 6-months & 12-month
Dyspnoea-12 (D-12)
The Dyspnoea-12 (D-12) has 12 breathlessness descriptors pertaining to the different qualitative dimensions of breathlessness, rated on a 0-4 Likert scale, where 0 = "none", 1= "mild", 2= "moderate" and 3= "severe". All items of the D-12 can be summed for a total score (0-36). A higher score signifies more severe breathlessness. The minimal clinically important difference has been estimated to be 3 units.
Measured: 6-months & 12-months
Physical activity
Participants will be provided an accelerometer to wear for 10 continuous days, 24-hrs per day. The accelerometer will capture data on physical activity levels (intensity, frequency, and duration). Average time per day/week spent in light-, moderate- and vigorous-intensity physical activity will be evaluated and recorded.
Measured: 6-months & 12-months
Theoretical framework of acceptability (TFA) questionnaire
The Theoretical Framework of Acceptability (TFA) is a generic questionnaire that assesses intervention acceptability from recipients' perspectives across seven constructs. Items are rated on a 0-5 likert scale, with higher scores indicating greater perceived acceptability, appropriateness, and fewer barriers to use.
Measured: 6-months & 12-months
EuroQol 5-Dimension 5-Level ( EQ-5D-5L)
The EQ-5D-5L consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-level scale (1 = no problems to 5 = extreme problems), and a 0-100 visual analogue scale (0 = the worst health to 100 = the best health) for self-rated health. This self-report questionnaire will be used to generate health utility weights and Quality Adjusted Life Years (QALYs) for a health economic analysis.
Measured: 12-months
Acceptability of Intervention Measure (AIM)
The AIM is part of a systematically developed valid, reliable, and pragmatic measure of three key implementation outcomes (acceptability, appropriateness and feasibility). AIM specifically measures the acceptability of the intervention which consists of four items rated on a 5-point likert scale, with higher scores indicating greater perceived acceptability of the intervention.
Measured: 6-months & 12-months
Intervention Appropriateness Measure (IAM)
The IAM is part of a systematically developed valid, reliable, and pragmatic measure of three key implementation outcomes (acceptability, appropriateness and feasibility). IAM specifically measures the appropriateness of the intervention which consists of four items rated on a 5-point likert scale, with higher scores indicating greater perceived appropriateness of the intervention.
Measured: 6-months & 12-months
Feasibility of Intervention Measure (FIM)
The FIM is part of a systematically developed valid, reliable, and pragmatic measure of three key implementation outcomes (acceptability, appropriateness and feasibility). FIM specifically measures the feasibility of the intervention which consists of four items rated on a 5-point likert scale, with higher scores indicating greater perceived feasibility of the intervention.
Measured: 6-months & 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Newcastle, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Australia, The Hong Kong Polytechnic University, University of Sao Paulo, The Thoracic Society of Australia and New Zealand, Asthma Australia, Hunter New England Local Health District
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421115
- Sponsor's protocol ID
- R-2025-0039
- Other IDs
- G2300366
- Acronym
- BRAID
- Status last verified
- Feb 2026
- First submitted
- 24 Aug 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared through mediated access, managed by the designated data custodian, subject to (1) Explicit participant consent for data sharing and re-use obtained during the consent process, (2) appropriate data sharing agreements with requesting parties, and (3) review of the proposed re-use to ensure alignment with the original consent.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Breathlessness and Physical Activity Intervention in People With Moderate to Severe Asthma Using a Supported Digital Platform
- ClinicalTrials.gov ID
- NCT07421115
- Acronym / sponsor ID
- BRAID / R-2025-0039
- Conditions
- Asthma (Diagnosis), Breathlessness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Newcastle, AustraliaUniversity, hospital or other
- Collaborators
- University of South Australia, The Hong Kong Polytechnic University, University of Sao Paulo, The Thoracic Society of Australia and New Zealand, Asthma Australia, Hunter New England Local Health District
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treating breathlessness could help people with asthma have fewer symptoms and be more physically active. People with asthma report that it is important to deal with breathlessness during physical activity programs, but past research hasn't focused on this need.
The investigators have developed a multicomponent digitally supported intervention targeting breathlessness and physical inactivity. This study will test whether the multicomponent digital supported intervention will help people with asthma. The main question the study aims to answer is:
Does the multicomponent digitally supported intervention improve quality of life?
Participants will:
- Be allocated to the intervention or usual care. Allocation to either group will be random (like tossing a coin).
- Attend study visits to complete an assessment involving questionnaires and measurements
- Receive telephone calls to ask questions about health
- Be invited to take part in an interview to have a conversation about thoughts on participating in the study
- Be asked to provide consent to collect information from Services Australia regarding use of health care services and medications
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital self-management platform and enhanced usual care | Experimental | Behavioral: Multicomponent digital self-management platform, Other: Enhanced usual care |
| Enhanced usual care | Other | Other: Enhanced usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Able to provide informed consent
- Evidence of variable airflow limitation within the past 10-years to confirm asthma diagnosis
- Meets diagnostic criteria for moderate, or severe asthma
- Reports breathlessness impacting daily life physical activities (modified Medical Research Council [mMRC] dyspnoea score ≥1) within the past 1-week
Key exclusion criteria (4 listed)
- High dependence on medical care
- Significant life-limiting comorbidity (<12 months life expectancy)
- Cognitive impairment, poor English language skills or significant untreated hearing impairment that prevents completion of data collection forms or understanding of verbal instructions
- Current participation in any other clinical trial, or participation in another clinical trial within the 4-weeks preceding study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent digital self-management platformAttend an in-person session with an respiratory nurse, focused on breathlessness and physical activity self-management; and be provided access to a digital self-management platform | Behavioural | Digital self-management platform and enhanced usual care |
| Enhanced usual careEnhanced usual asthma tertiary care | Other | Digital self-management platform and enhanced usual care, Enhanced usual care |
Primary outcome
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: 6-months
Items are rated on a 7-point Likert scale, with higher scores indicating better quality of life. A mean score across all items equally weighted is reported. The minimal clinically important difference has been estimated to be 0.5 units.
10 secondary outcomes
Asthma Control Questionnaire-5 (ACQ-5)
Time frame: 6-months & 12-months
Shortness of Breathlessness with Daily Activities (SOBDA)
Time frame: 6-months & 12-month
Multidimensional Dyspnea Profile (MDP)
Time frame: 6-months & 12-month
Dyspnoea-12 (D-12)
Time frame: 6-months & 12-months
Physical activity
Time frame: 6-months & 12-months
Theoretical framework of acceptability (TFA) questionnaire
Time frame: 6-months & 12-months
EuroQol 5-Dimension 5-Level ( EQ-5D-5L)
Time frame: 12-months
Acceptability of Intervention Measure (AIM)
Time frame: 6-months & 12-months
Intervention Appropriateness Measure (IAM)
Time frame: 6-months & 12-months
Feasibility of Intervention Measure (FIM)
Time frame: 6-months & 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared through mediated access, managed by the designated data custodian, subject to (1) Explicit participant consent for data sharing and re-use obtained during the consent process, (2) appropriate data sharing agreements with requesting parties, and (3) review of the proposed re-use to ensure alignment with the original consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent digital self-management platform in people with Asthma (Diagnosis) and Breathlessness, run by University of Newcastle, Australia at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa M McDonald (+61 2 40420146, vanessa.mcdonald@newcastle.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Quality of Life Questionnaire (AQLQ) (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.