An interventional study of Multicomponent digital self-management platform and Enhanced usual care in Asthma (Diagnosis) and Breathlessness, sponsored by University of Newcastle, Australia. Not yet recruiting at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by University of Newcastle, Australia · Not applicable, Interventional, and Other
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:
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 300 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Newcastle, Australia is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Multicomponent digital self-management platform · Other: Enhanced usual care
Other: Enhanced usual care
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 asthma tertiary care
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.
Time frame: 6-months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6-months & 12-months
Plan to share: 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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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Newcastle, Australia