Improving the lives of people living with chronic breathlessness due to advance disease via a self-guided, internet-based breathlessness supportive intervention SELF-BREATHE

Background Over 3 million people experience chronic breathlessness (despite optimal treatment of underlying diseases) each year in the UK. Breathlessness increases with disease progression, becoming chronic resulting in high symptom burden, poor quality of life, increased disability, high health and social care costs, driven by repeat Emergency Department (ED) attendance and hospitalisation. In addition, people living with long COVID commonly have breathlessness and struggle to manage it, further increasing the demand for breathlessness supportive services. A proactive approach to tackle breathlessness is required to build capacity and resilience within health systems, especially given rising health and social care costs, and workforce challenges. SELF-BREATHE is one potential solution. SELF-BREATHE is an innovative digital approach to support those living with breathlessness, developed during my NIHR Clinical Lectureship. SELF-BREATHE is feasible to deliver, and acceptable to patients. However, the clinical efficacy is yet to be rigorously tested. What is the research question / aims and objectives? To determine the clinical efficacy of SELF-BREATHE for patients living with chronic breathlessness compared to usual NHS care. Primary research question To determine if using SELF-BREATHE for six-weeks, reduces breathlessness in patients living with chronic breathlessness compared to those receiving usual NHS care Secondary research questions To determine whether SELF-BREATHE improves health-related quality of life (HRQoL), illness perception, and patients' behavioural responses breathlessness after six-weeks. To explore the sustained use of SELF-BREATHE after six-weeks and what impact this has on breathlessness, HRQoL and ED attendance. Methodology Follows the MRC framework for developing and evaluating complex interventions and the IDEAS (Integrate, DEsign, Assess and Share) framework for the development of digital behavioural change interventions. Study Design A single blind, multicentre, parallel, two arm randomised controlled trial with participants allocated to 1) intervention group (SELF-BREATHE + usual NHS care) or 2) control group (usual NHS care). Population Patients living with chronic breathlessness due to advanced disease. Intervention SELF-BREATHE, is an online self-guided breathlessness intervention, providing unlimited online access to education and self-management interventions e.g., breathing control, home exercises. Control Usual NHS care as available to patients prior to entry into the trial. Primary outcome Worst breathlessness over the last 24 hours quantified on 0 - 10 numerical rating scale with 10 being worst imaginable. Differences between groups at 6 weeks (primary endpoint) and 6 months post randomisation, will be compared. Secondary outcomes HRQoL, illness perception, use of SELF-BREATHE after six-weeks, ED attendance. Sample size Based on the primary outcome, worst breathlessness measured using the numerical rating scale to detect a mean difference of 1 (the minimally clinically importance difference) with a standard deviation of 2 and a 5% significant level, power 90%, 86 patients per group (172 in total) are required. The feasibility RCT had 30% attrition; thus, allowing for loss to follow up of 30% at 6 weeks, our recruitment target is 246 patients over 36-months, i.e., 6.8. patients per month. Anticipated impact and dissemination Determined clinical efficacy of SELF-BREATHE, directly influencing policy and service delivery, with SELF-BREATHE available to patients irrespective of diagnosis or geographical location.