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临床试验/NCT06706765
NCT06706765招募中1 期

Group Telehealth Behavioral Cough Suppression Therapy Pilot Study

University of Montana1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月22日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Leicester Cough Questionnaire

研究概览

简要总结

The purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (BCST) in managing refractory chronic cough (RCC) within a group telehealth setting. RCC is a cough that has lasted at least 8 weeks and has not resolved with standard medical treatment. BCST is a research-based treatment provided by specialty-trained speech-language pathologists (SLPs) for patients with RCC. Although the treatment works very well for a large proportion of patients in a standard one-on-one format, there are a limited number of SLPs available to provide this treatment and patients living in rural areas do not typically have access to an SLP trained in BCST. If BCST can effectively be delivered in a group telehealth model, it would significantly improve accessibility to the treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • •At least 18 years old
  • •Predominantly dry cough for at least 8 weeks
  • •Evaluated and treated by at least one physician for cough
  • •Obtained a chest X-ray or chest CT scan specifically related to the cough with unremarkable results
  • •Access to a computer or tablet that includes a camera and able to use the device independently
  • •Reliable internet access
  • •Willing to agree to maintain confidentiality of personal information (including names) related to others in the study

排除标准

  • •Under age 18
  • •Coughing up blood
  • •Current smoker of any substance
  • •History of smoking or 10 or more years
  • •Diagnosed with a chronic lung condition (e.g., COPD, emphysema, lung cancer, idiopathic pulmonary fibrosis, chronic bronchitis, asthma)? (NOTE: If a patient has been told their cough may be (or is likely) due to asthma but they have not had any formal lung testing and asthma treatments have not helped your cough, we don't consider this a formal asthma diagnosis and will not exclude them from the study.)
  • •Diagnosed currently or in the past with head and neck cancer (i.e., cancer of the mouth, nose, or throat).
  • •Complaints of swallowing difficulty
  • •Taking any of the following medications, which have a known side effect of cough: 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)
  • •Prior BCST treatment with an SLP or respiratory therapist

研究组 & 干预措施

Group Telehealth Behavioral Cough Suppression Therapy

Experimental

干预措施: Behavioral Treatment (Behavioral)

结局指标

主要结局

Leicester Cough Questionnaire

时间窗: Baseline, one-week post-treatment, and one-month post-treatment

The Leicester Cough Questionnaire is a 19-item self-report questionnaire that is valid and reliable, and repeatable every two weeks. The total possible score is 21. The higher the score the better the cough-related quality of life.

次要结局

  • Patient Global Impression of Severity Scale in Chronic Cough(Baseline, every treatment session (4-6 treatment sessions, one treatment session per week), and one-month post-treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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