COUGH-LESS: Chronic COUGH Management in Interstitial Lung DisEase - Non-pharmacological Strategies and Solutions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Leicester Cough Questionnaire (LCQ)
研究概览
简要总结
Interstitial Lung Disease (ILD) includes chronic, disabling and progressive respiratory conditions marked by lung inflammation and fibrosis. The quality of life and functionality of people with ILD is affected by a plethora of debilitating symptoms such as dyspnoea fatigue and cough. Among them, chronic cough (a cough lasting more than 8 weeks) reigns as one of the most prevalent and challenging, despite receiving far less attention from researchers than other symptoms. Chronic cough affects up to 8 out of 10 individuals with ILD and it is associated with a worse prognosis, mortality, and the need for lung transplantation. This condition showed a significant impact in people's life (e.g., urinary incontinence, speech interferences, depression, chest pain, couples sleeping in separate bedrooms, avoidance of public areas, reduced social interaction, and work absenteeism), further contributing to the decreased health-related quality of life experienced by this population. Managing chronic cough is, therefore, urgently needed. The general aim of this study is to explore the effects of a non-pharmacological cough control treatment on cough-related quality of life in people with ILD. The specific aims of this study are: i) to explore short- and mid-term effects of the non-pharmacological cough control treatment on cough related outcomes (e.g., cough frequency and intensity, dyspnoea, fatigue, cough self-efficacy, health-related quality of life and emotional status); ii) to identify (if any) adverse effects of this therapy.
详细描述
Interstitial Lung Disease (ILD) comprises chronic, disabling, and progressive respiratory conditions marked by lung inflammation and fibrosis. The quality of life and functionality of people with ILD is affected by a plethora of debilitating symptoms such as dyspnoea, fatigue, and cough. Among them, chronic cough reigns as one of the most prevalent and challenging, despite receiving far less attention from researchers than other symptoms.
Chronic cough (a cough lasting for > 8 weeks) and affects up to 8 out of 10 individuals with ILD. It is associated with a worse prognosis, mortality, and the need for lung transplantation. This condition also causes urinary incontinence, interferes with speech, and presents psychosocial and physical manifestations, such as depression and chest pain. Chronic cough can also lead to relationship problems, such as couples sleeping in separate bedrooms, avoidance of public areas, reduced social interaction, and work absenteeism, further contributing to the decreased health-related quality of life experienced by this population. Managing chronic cough is, therefore, urgently needed.
Currently, there is no approved drug to manage chronic cough in people with ILD. Conversely, non-pharmacologic cough control therapies have demonstrated similar efficacy without side effects. Studies have shown that non-pharmacological cough control therapy can improve cough-related quality of life and reduce cough frequency in individuals with refractory (i.e., cough that lasts despite optimal treatment) chronic cough. Promising results were observed in a case-study on people with chronic cough and ILD. However, well-designed randomized controlled trials (RCTs) with adequate power are needed to establish the effects of non-pharmacological cough control therapy on people with ILD.
The primary aim of this study is to explore the effects of a non-pharmacological cough control treatment on cough-related quality of life in people with ILD. The specific aims of this study are: i) to explore short- and mid-term effects of the non-pharmacological cough control treatment on cough related outcomes (e.g., cough frequency and intensity, dyspnea, fatigue, cough self-efficacy, health-related quality of life and emotional status); ii) to identify (if any) adverse effects of this therapy.
COUGH-LESS randomized trial Potential participants will be identified and recruited through the pulmonology services of the Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre-o-Douro e Vouga (CHEDV).
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 (Participant, Investigator)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i) Adults (>18 years old) ii) Clinical diagnosis of ILD iii) Presenting chronic cough (> 8 weeks of duration) iv) People with access to a virtual meeting platform/telephone.
排除标准
- •i) Self-reports of moderate or large sputum production (> 2 tablespoons); ii) Actual or suspected exacerbation of the respiratory condition in the last month; iii) Upper respiratory tract infection (e.g. cold); iv) Use of angiotensin-converting enzyme inhibitor medication; v) Changes in prescribed medication in the last month; vi) Signs of cognitive impairment or significant cardiovascular, neurological and/or musculoskeletal disease that may limit participation in the program; vii) Inability to read or speak Portuguese; viii) Inability to provide informed consent.
研究组 & 干预措施
COUGH-LESS Programme
干预措施: Non-pharmacological cough control therapy (Behavioral)
Control Group
干预措施: Healthy lifestyle (Behavioral)
结局指标
主要结局
Change in Leicester Cough Questionnaire (LCQ)
时间窗: One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.
The LCQ is a reliable, responsive questionnaire recommended by various guidelines for assessing chronic cough. This questionnaire comprises 21 questions referring to the two weeks prior to completing it. The LCQ assesses three domains (psychological, social and physical) and also gives a total score. The maximum score that can be obtained on the LCQ is 21 points in total (7 in each domain) where higher scores translate into a higher quality of life related to coughing.
次要结局
- Change in Modified British Medical Research Council Dyspnea Scale (mMRC)(One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.)
- Change in Cough Visual Analogic Scale (CVAS)(One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.)
- Change in Chronic Airways Assessment Test (CAAT)(One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.)
- Change in One minute sit-to-stand test (1min-STS)(One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.)
- Six-minute Walking Test (6MWT)(One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.)
- Change in Cough Hypersensitivity Questionnaire (CHQ)(One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.)
- Change in Hospital Anxiety and Depression Scale (HADS)(One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.)
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS)(One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.)
- Change in King's Brief Interstitial Lung Disease (K-BILD)(One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.)
- Interviews(One measurement will be assessed at baseline and 7 weeks after (post-intervention))
- Adherence to the COUGH-LESS programme(Only one measurement will be assessed after 7 weeks after baseline (post-intervention).)
- Occurrence of adverse events(One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.)
研究者
Prof Ana Oliveira
Assistant professor
Aveiro University