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
| Autor: | Adrienne Kirby, Ester Klimkeit, Jin-Gun Cho, John R. Wheatley, Mary Roberts, Tracy Smith, Nikki McCaffrey, Tim Luckett |
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| Rok vydání: | 2020 |
| Předmět: |
COPD
education.field_of_study medicine.medical_specialty business.industry Population Context (language use) randomized-controlled trial dyspnea respiratory system medicine.disease Hospital Anxiety and Depression Scale chronic obstructive pulmonary disease law.invention Clinical trial FEV1/FVC ratio Quality of life (healthcare) Randomized controlled trial law Physical therapy Medicine Original Article business education clinical protocol |
| Zdroj: | Palliative Medicine Reports |
| ISSN: | 2689-2820 |
| DOI: | 10.1089/pmr.2020.0081 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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