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.

Abstract

Background: 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.Methods: 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.Population: At least moderate COPD (FEV1:FVC ≤0.7; FEV1%predicted ≤60%) and persistent disabling breathlessness (modified Medical Research Council ≥2).Intervention: 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.Control: Participants who receive the WBS intervention after an eight-week period while receiving usual care (standard care group).Outcome: 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.Discussion: This study aims to establish the efficacy and cost-effectiveness of an eight-week nonpharmacological breathlessness intervention in patients with COPD.Trial Registration: The Australian New Zealand Clinical Trial Registry ACTRN12617000499381 (06/04/17).