Protocol for a Single-Blind, Randomized, Parallel-Group Study of a Nonpharmacological Integrated Care Intervention to Reduce the Impact of Breathlessness in Patients with Chronic Obstructive Pulmonary Disease.

Patients with chronic obstructive pulmonary disease (COPD) frequently experience breathlessness despite maximal medical therapy. Nonpharmacological management is effective in studies enrolling patients with a variety of respiratory diseases; however, the impact on patients with COPD is unclear. A protocol for a mixed-methods, single-center, observer-blinded, fast-track randomized-controlled, parallel-group trial comparing an immediate eight-week nonpharmacological Westmead Breathlessness Service (WBS) to a standard care control group is described. At least moderate COPD (FEV1:FVC ≤0.7; FEV1%predicted ≤60%) and persistent disabling breathlessness (modified Medical Research Council ≥2). Individualized prescription of nonpharmacological breathlessness interventions, including a handheld fan, breathing techniques, postures to relieve breathlessness, relaxation, nutritional advice, energy conservation, and exercise advice delivered by a team including doctors, nurses, a physiotherapist, an occupational therapist, a dietitian, and speech pathologist. Participants who receive the WBS intervention after an eight-week period while receiving usual care (standard care group). Primary outcome-Chronic Respiratory Questionnaire (CRQ) Mastery subscale. Secondary outcomes include numerical rating scale of breathlessness intensity, unpleasantness, and confidence managing breathlessness; quality of life as measured by other CRQ subscales; Hospital Anxiety and Depression Scale score; daily step count; health resource utilization 12 months pre- and postintervention; and cost-effectiveness. Qualitative analysis of participant interviews will provide additional context for interpreting the quantitative results. This study aims to establish the efficacy and cost-effectiveness of an eight-week nonpharmacological breathlessness intervention in patients with COPD. The Australian New Zealand Clinical Trial Registry ACTRN12617000499381 (06/04/17).