Randomised controlled trial of a non-pharmacological integrated care intervention to reduce breathlessness in patients with severe or very severe chronic obstructive pulmonary disease (COPD)

Westmead Hospital0 个研究点目标入组 94 人开始时间: 2017年4月6日最近更新: 2021年7月12日

适应症

试验速览

暂无简介。

•a)Moderate to very severe COPD by GOLD criteria (FEV1 less than 60% predicted; FEV1/FVC ratio less than 70%)
•b)Severe breathlessness: mMRC greater than or equal to 2 (on mMRC 0-4 scale; ie On level ground, I walk slower than people of the same age because of breathlessness, or I have to stop for breath when walking at my own pace on the level”)
•c)Subject is willing and able to be an active participant in their care
•d)Either completed pulmonary rehabilitation within 1 year or unwilling to attempt pulmonary rehabilitation due to perceived breathlessness (NB randomisation will be stratified for pulmonary rehab completion as these may be clinically different groups and we wish to ensure equal numbers from these categories in each group)
•e)Informed consent given

•a) Bed bound
•b) Diagnosis of dementia or cognitive impairment
•c) Subject unwilling or unable to actively participate in trying new interventions to address breathlessness
•d) No usual medical practitioner (either specialist or general practitioner (GP)) involved in the patient’s care
•e) Subject unable to comply with study procedures in the opinion of the investigator or the subject’s usual medical team
•f) Subjects with a current active diagnosis of cancer, primary respiratory disease other than COPD, substance abuse, other uncontrolled medical disorder.
•g) Subjects with a moderate to severe exacerbation of COPD requiring hospitalisation within the last 4 weeks.
•h) Subjects with a primary diagnosis of congestive cardiac failure
•i) Inability to understand sufficient English to complete study procedures or instruments

发起方

Westmead Hospital