Asthma (Diagnosis), Breathlessness
Conditions
Brief summary
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
BEHAVIORALMulticomponent 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
OTHEREnhanced usual care
Enhanced usual asthma tertiary care
Sponsors
University of Newcastle, Australia
University of South Australia
The Hong Kong Polytechnic University
University of Sao Paulo
The Thoracic Society of Australia and New Zealand
Asthma Australia
Hunter New England Local Health District
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Quality of Life Questionnaire (AQLQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Questionnaire-5 (ACQ-5) | 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. |
| Shortness of Breathlessness with Daily Activities (SOBDA) | 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. |
| Multidimensional Dyspnea Profile (MDP) | 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. |
| Dyspnoea-12 (D-12) | 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. |
| Physical activity | 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. |
| Theoretical framework of acceptability (TFA) questionnaire | 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. |
| EuroQol 5-Dimension 5-Level ( EQ-5D-5L) | 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. |
| Acceptability of Intervention Measure (AIM) | 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. |
| Intervention Appropriateness Measure (IAM) | 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. |
| Feasibility of Intervention Measure (FIM) | 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. |
Countries
Australia
Contacts
CONTACTVanessa M McDonald
CONTACTHayley Lewthwaite
Outcome results
None listed