Internet-Behavioral Cough Suppression Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Leicester Cough Questionnaire
研究概览
简要总结
The goal of this randomized, placebo-controlled, clinical trial is to develop and test the efficacy of an Internet-based behavioral intervention for refractory chronic cough. The main questions it aims to answer are:
- What are the best recruitment pathways to find people living with refractory chronic cough in Montana?
- Is Internet-Behavioral Cough Suppression Therapy (iBCST) efficacious?
- Do iBCST participants find it satisfactory?
- Is using Hyfe research app to monitor cough frequency feasible in rural areas?
Participants will complete iBCST or a placebo treatment virtually. Some participants will take part in qualitative interviews and use Hyfe research app for ambulatory cough frequency monitoring.
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
- Single (Participant)
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
- •No barriers to using a computer or smartphone (e.g., no significant fine motor or visual problems).
- •Internet and e-mail access and the ability to use it.
- •Suffering from a cough lasting at least eight weeks that is:
- •Largely unproductive (cough up no more than a few teaspoons worth of clear or white sputum or mucus in a 24-hour period).
- •Report of cough triggered by identifiable stimuli including and not limited to any combination of the following: cold air, talking, laughing, taking a deep breath, exercise, crumbly foods, strong smells or odors, fumes from paint or cleaning sprays.
- •Often preceded by the sensation of an urge-to-cough (e.g., tickle or itch) at the level of the throat.
- •Self-report of receiving the following assessments for current cough symptoms with unremarkable results:
- •Physical evaluation by at least one physician.
- •Chest x-ray.
- •Willingness to avoid other potential cough treatments during the course of the study (or alert study personnel if alternative treatment is implemented out of necessity).
排除标准
- •Current smoker of any substance.
- •Diagnosis of any of the following:
- •Respiratory disease (e.g., chronic obstructive pulmonary disease, asthma)
- •Neurogenic disease (e.g., Parkinson's disease, cerebrovascular disease)
- •Head and neck cancer
- •Self-report of difficulty swallowing since having chronic cough
- •Use of the following medication:
- •Angiotensin-converting enzyme inhibitor (ACE-I) in the past four weeks: benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik).
- •Use of a neuromodulator medication in the past 48 hours: Neurontin (Gabapentin) and amitriptyline.
- •Individuals with dysphonia (abnormal voice; either self-reported or perceived by study personnel during enrollment interview) will be excluded unless they have had a normal laryngoscopy (endoscopic assessment of the larynx) by an otolaryngologist (ENT) within the past year specifically for their cough.
结局指标
主要结局
Leicester Cough Questionnaire
时间窗: Pre-treatment, one-week post-treatment, one-month post-treatment
Cough-related quality of life will be measured with the Leicester Cough Questionnaire (LCQ), a valid, reliable, and repeatable measure of cough-related quality of life. The LCQ is a 19-item questionnaire containing physical, psychological, and social domains. Scores for the LCQ include mean scores for each domain (ranging from 1 to 7) and a total score calculated as the sum of the domain scores (ranging from 3 to 21). A higher score indicates better quality of life. A change in 1.3 is considered clinically significant. The LCQ total score was the primary outcome measure in this study.
次要结局
- Cough Severity Visual Analog Scale(Pre-intervention, one-week post-treatment, one-month post-treatment)