Group Telehealth Behavioral Cough Suppression Therapy

Официальное название

Group Telehealth Behavioral Cough Suppression Therapy Pilot Study

Обзор

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.

Вмешательства

• Поведенческое Behavioral Treatment
  Behavioral cough suppression therapy delivered in a group setting via telehealth.

Первичные конечные точки

• Leicester Cough Questionnaire [Срок оценки: Baseline, one-week post-treatment, and one-month post-treatment]

Вторичные конечные точки (1)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Montana — Missoula

Идентификаторы

NCT: NCT06706765 · IRB-FY2024-36

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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