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NCT Number: NCT07421115

Multicomponent Breathlessness and Physical Activity Intervention in People With Asthma Using a 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:

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Hunter Hospital, New Lambton Heights, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Multicomponent digital self-management platform

Behavioral

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 care

Other

Enhanced usual asthma tertiary care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Asthma Control Questionnaire-5 (ACQ-5)

    Time frame: 6-months & 12-months

    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.

  2. Shortness of Breathlessness with Daily Activities (SOBDA)

    Time frame: 6-months & 12-month

    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.

  3. Multidimensional Dyspnea Profile (MDP)

    Time frame: 6-months & 12-month

    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.

  4. Dyspnoea-12 (D-12)

    Time frame: 6-months & 12-months

    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.

  5. Physical activity

    Time frame: 6-months & 12-months

    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.

  6. Theoretical framework of acceptability (TFA) questionnaire

    Time frame: 6-months & 12-months

    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.

  7. EuroQol 5-Dimension 5-Level ( EQ-5D-5L)

    Time frame: 12-months

    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.

  8. Acceptability of Intervention Measure (AIM)

    Time frame: 6-months & 12-months

    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.

  9. Intervention Appropriateness Measure (IAM)

    Time frame: 6-months & 12-months

    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.

  10. Feasibility of Intervention Measure (FIM)

    Time frame: 6-months & 12-months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hayley Lewthwaite

CONTACT

[email protected]

+61 2 4985 4582

Vanessa M McDonald

CONTACT

[email protected]

+61 2 40420146

Sponsors and collaborators

Lead sponsor

University of Newcastle, Australia

Other

Collaborators

  • Asthma Australia
  • Hunter New England Local Health District
  • The Hong Kong Polytechnic University
  • The Thoracic Society of Australia and New Zealand
  • University of Sao Paulo
  • University of South Australia

Registry information

Official study title

Multicomponent Breathlessness and Physical Activity Intervention in People With Moderate to Severe Asthma Using a Supported Digital Platform

Acronym: BRAID

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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