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临床试验/CTRI/2023/05/052696
CTRI/2023/05/052696尚未招募不适用

Efficacy of a behavioural intervention for chronic refractory cough: a randomized control trial

Yamini Venkatraman1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年6月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Leicester cough questionnaire (LCQ), Cough Symptom Score (CSS), Cough Visual Analogue Scale (CVAS)

研究概览

简要总结

Cough is a commonsymptom of many respiratory conditions such as Chronic Obstructive PulmonaryDisease(COPD), upper airway cough syndrome (UACS), asthma, and reflux diseases. These conditions are optimallyassessed and treated as per standard guidelines recommended by TheAmerican  College of Chest Physicians(CHEST) and European Respiratory Society (ERS). When the cough persists beyond 8weeks, with an unidentified etiology, a normal chest X-ray, and is notresponding to medical treatment for the common causes, it is labelled as ‘chronicrefractory cough (CRC)’. These patients undergo multipleclinic visits, assessment procedures, and treatment trials before beinglabelled with CRC and continue to suffer from the consequences of chroniccough. They experience a deterioration in their physical well-being and quality of life in socialcontexts, work life, and leisure. The cough remains unresolved orpartially treated with medical management and thus alternative approaches areexplored. A multi-disciplinary approach tothe management of cough is advocated in the literature. Novel treatment approaches have emerged which targets the behaviouralaspects – in addition to the existing standard of care. The behaviouralinterventions involved sessions focusing on four key principles: cougheducation, cough suppression techniques, vocal hygiene and psycho-educationalcounselling. More efficacy studies onbehavioural interventions are needed to bring awareness among physicians andclinicians. The present study intends to investigate the effectiveness of abehavioural intervention in the treatment of chronic refractory cough.

**Hypothesis statement -**The patients who receive both medical and behaviouralintervention will show improvement in terms of cough related quality of lifeand cough severity scores compared to the group receiving only medicalintervention.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients with a cough complaint duration of 3-8 weeks or more, who have undergone comprehensive diagnostic evaluations and optimally treated as per the protocols but are still symptomatic/refractory to medical management for cough.
  • Adults who can read and speak Kannada, who are never smokers or former smokers will be included.

排除标准

  • Patients with a history of cognitive disorders, speech-language disorders and neurodegenerative disorders will be excluded.
  • Diagnoses of active infections and carcinomas of the pulmonary system will also be excluded.
  • A cough complaint duration of less than 3 weeks will be excluded.
  • Patients who are on angiotensin-converting enzyme (ACE) inhibitor drugs, current smokers or everyday smokers will be excluded.

结局指标

主要结局

Leicester cough questionnaire (LCQ), Cough Symptom Score (CSS), Cough Visual Analogue Scale (CVAS)

时间窗: Baseline | Post-treatment | Follow-up after 8 weeks

次要结局

  • Acoustic analysis-Spectral amplitude measures(Baseline)
  • Voice Handicap Index (VHI) scores(Baseline)
  • Consensus Auditory Perceptual Evaluation of Voice (CAPE-V) scores(Baseline)

研究者

发起方
Yamini Venkatraman
申办方类型
Other [self]

研究点 (1)

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