Multicomponent Breathlessness and Physical Activity Intervention in People With Asthma Using a Digital Platform
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multicomponent digital self-management platform, Enhanced usual care.
- Who it may be relevant to
- Registry conditions: Asthma (Diagnosis), Breathlessness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicomponent Breathlessness and Physical Activity Intervention in People With Moderate to Severe Asthma Using a Supported Digital Platform
Overview
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
Interventions
- 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
Primary outcome measures
- Asthma Quality of Life Questionnaire (AQLQ) [Time frame: 6-months]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Australia · 2 centers
- John Hunter Hospital — New Lambton Heights
- The Prince Charles Hospital — Chermside
Identifiers
NCT: NCT07421115 · R-2025-0039 · G2300366