None listed
Conditions
Brief summary
This study aims to evaluate the effectiveness of the ‘Primary Breathe Australia self-management intervention’ for chronic breathlessness. Who is it for? You may be eligible for this study if you are a male or female, aged 18 or over, and expected survival of 3 months at time of recruitment. You must have a clinician-confirmed diagnosis of at least one of the following CRDs: chronic obstructive Chronic obstructive pulmonary disease (COPD), Interstitial lung disease (ILD), Chronic asthma, Bronchiectasis, and lung cancer. Study details Participants will be randomly assigned to either intervention arm (Primary Breathe Australia self-management intervention) or treatment as usual. The Primary Breathe Australia self-management intervention consists of at least 2, but up to 3, one-on-one clinical consultations delivered over an 8-week period (or shorter period according to patient preference) by the Primary Breathe Australia nurse who is embedded within the primary care or residential aged care site. Each consultation is expected to last 20-60 minutes. The content of the interventions will involve patient assessment, general chronic breathlessness education, non-pharmacological self-management education, and provision of digital resources developed for the intervention. During and after the intervention, participants will be assessed using questionnaires for breathlessness, qualify of life, distress, anxiety, depression and fatigue. It is hoped that this research will demonstrate a scalable approach to improving the management of chronic breathlessness, leading to better symptom control and quality of life for people living with chronic respiratory conditions and other diseases.
Interventions
There are two arms in the study, the Primary Breathe Australia self-management intervention (intervention arm) or usual care (control arm).
Participants assigned to the intervention arm will be entered into the Primary Breathe Australia self-management intervention.
The Primary Breathe Australia self-management intervention consists of at least 2, but up to 3, one-on-one clinical consultations delivered over an 8-week period (or shorter period according to patient preference) by the Primary Br
There are two arms in the study, the Primary Breathe Australia self-management intervention (intervention arm) or usual care (control arm). Participants assigned to the intervention arm will be entered into the Primary Breathe Australia self-management intervention. The Primary Breathe Australia self-management intervention consists of at least 2, but up to 3, one-on-one clinical consultations delivered over an 8-week period (or shorter period according to patient preference) by the Primary Breathe Australia nurse who is embedded within the primary care or residential aged care site. Each consultation is expected to last 20-60 minutes and can be delivered face-to-face or via telehealth. The content of the interventions will involve patient assessment, general chronic breathlessness education, non-pharmacological self-management education, and provision of digital resources developed for the intervention. Adherence will be measured using post-consultation summaries.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each participant must meet the following criteria to be enrolled in this trial: • Have a clinician-confirmed diagnosis of at least one of the following chronic respiratory diseases (CRD): o Chronic obstructive pulmonary disease (COPD) o Interstitial lung disease (ILD) o Chronic asthma o Bronchiectasis o Lung cancer • Experienced moderate to severe breathlessness (equivalent to 2 or more on mMRC) for 3 months or more • Aged greater than or equal to 18 years • Expected survival of greater than or equal to 3 months at time of recruitment (as determined by community clinicians e.g., local GP) • Is listed as an active patient in the EMR at the recruiting primary care practice (defined as =1 visit in previous 12 months and/or self-report as main primary care practitioner) OR is a residential client of the recruiting residential aged care facility • CRD is optimally managed as defined by clinician judgement (for primary care recruited participants) • Willing and able to complete study assessments and provide informed consent.
Exclusion criteria
Patients not meeting all of the inclusion criteria or meeting any of the following criteria will be excluded from the trial: • Significant cognitive impairment which prevents the participant from actively engaging with non-pharmacological breathlessness self-management strategies as indicated by a score of 0-3 on the General Practitioner's Assessment of Cognition (GPCOG) • Unable to understand or comply with a self-management intervention for breathlessness • Exacerbation of CRD within the past 4 weeks • Changes to respiratory medications or treatments (including supplemental oxygen therapy) within the past 4 weeks • Commencement or change of opioids or psychotropic medications within the past 4 weeks
Outcome results
None listed