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
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
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.
Parallel
Multicomponent digital self-management platform
BehavioralAttend 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 interventionEnhanced 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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
University of Newcastle, Australia
Lead sponsor
University of South Australia
Collaborator
The Hong Kong Polytechnic University
Collaborator
University of Sao Paulo
Collaborator
The Thoracic Society of Australia and New Zealand
Collaborator
Asthma Australia
Collaborator
Hunter New England Local Health District
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
