A Randomised Controlled Trial of the English National Opera Breathe Programme Compared With Usual Care in People Recovering From COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Change from baseline in RAND-36 (RAND SF-36)
研究概览
简要总结
A randomised clinical trial to assess the impact of an online singing, breathing and wellbeing programme (ENO Breathe) developed specifically for people recovering from COVID-19.
详细描述
BACKGROUND:
ENO Breathe is a breathing and wellbeing programme developed specifically for people recovering from COVID-19, who are still suffering from breathlessness and associated anxiety. Delivered by ENO in collaboration with Imperial College Healthcare teams entirely online, the programme focuses on breathing re-training through singing. Initial evaluation of the project suggested health improvements related to participation, however, a properly conducted efficacy study is needed.
DESIGN: An assessor blind, parallel group, randomised controlled trial, to assess the effects of ENO Breathe compared to usual care on health status. The study will also evaluate the impact on respiratory symptoms, anxiety, depression, and breathlessness perception to investigate the mechanisms involved.
RESEARCH QUESION AND OUTCOME MEASURES:
The primary outcome will be change in health status, assessed using the RAND-36 tool (RAND SF-36), comparing ENO Breathe and Usual Care arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Masking of participants not possible due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults recovering from COVID-19 with ongoing breathlessness and/or anxiety.
- •Referred from a specialist COVID-19 clinics aligned with the project, after appropriate clinical evaluation and investigation
- •Internet access with appropriate device (e.g. computer or tablet)
排除标准
- •Unable to participate due to comorbidity (e.g. life limiting illness, cognitive impairment)
结局指标
主要结局
Change from baseline in RAND-36 (RAND SF-36)
时间窗: At baseline, then repeated after 6 weeks.
A well-established, supervised, self-completion health status questionnaire. This consists of eight sections for which a score of 0 to 100 is created, with 0 being maximum disability and 100 equivalent to no disability.
次要结局
- Changes in COPD assessment test (CAT)(At baseline, then repeated after 6 weeks.)
- Changes in Visual Analogue Scale ratings of breathlessness(At baseline, then repeated after 6 weeks.)
- Changes in Generalised Anxiety Disorder Assessment (GAD-7)(At baseline, then repeated after 6 weeks.)
- Changes in Dyspnoea-12 questionnaire(At baseline, then repeated after 6 weeks.)
- Changes in Patient Health Questionnaire 9 (PHQ-9)(At baseline, then repeated after 6 weeks.)
- Changes in SF-6D (Short-Form Six-Dimension) scores(At baseline, then repeated after 6 weeks.)