Multicomponent Breathlessness and Physical Activity Intervention in People With Asthma Using a Digital Platform (BRAID)

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:

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 Overview

• Status: Not yet recruiting
• Conditions: Breathlessness; Asthma (Diagnosis)
• Intervention / Treatment: Behavioral: Multicomponent digital self-management platform; Other: Enhanced usual care

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa M McDonald; Phone Number: +61 2 40420146; Email: vanessa.mcdonald@newcastle.edu.au
• Study Contact Backup: Name: Hayley Lewthwaite; Phone Number: +61 2 4985 4582; Email: hayley.lewthwaite@newcastle.edu.au

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • John Hunter Hospital
      • Contact: Paola D Urroz Guerrero; Phone Number: +61 2 4042 0092; Email: paola.urroz@newcastle.edu.au
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
      • Contact: Ian Yang; Phone Number: +61 7 3139 5050; Email: Ian.Yang@health.qld.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital self-management platform and enhanced usual care	Behavioral: Multicomponent digital self-management platform; 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; Other: Enhanced usual care; Enhanced usual asthma tertiary care
Other: Enhanced usual care	Other: Enhanced usual care; Enhanced usual asthma tertiary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	6-months & 12-months

Collaborators and Investigators

• Sponsor: University of Newcastle, Australia
• Collaborators: The Hong Kong Polytechnic University; University of Sao Paulo; University of South Australia; The Thoracic Society of Australia and New Zealand; Asthma Australia; Hunter New England Local Health District

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: August 24, 2025
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Asthma; Disease; Dyspnea
• Other Study ID Numbers: R-2025-0039; G2300366 (Other Grant/Funding Number: National Health and Medical Research Council (Australia))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No