Chronic COUGH Management in Interstitial Lung DisEase
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAveiro University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Non-pharmacological cough control therapy
BehavioralOver seven weeks (1 session per week, except session 5, which will be 2 weeks after session 4) using a one-on-one hybrid model. In session 1, participants will receive general education about chronic cough, introduction to cough suppression and goal setting. Session 2 will cover education about chronic cough in ILD, cough triggers and training in cough suppression techniques. Session 3 will focus on hydration techniques, laryngeal hygiene, and breathing exercises to control coughing. Session 4 will reinforce all aspects of non-pharmacological cough control treatment, and session 5 will explore the sustainability of cough control strategies after the program using real-life case scenarios.
Healthy lifestyle
BehavioralOver seven weeks (1 session per week, except session 5, which will be 2 weeks after session 4) using a one-on-one hybrid model. In session 1, participants will receive general education about exercise and physical activity. Session 2 will cover education about diet. Session 3 will focus on stress management. Session 4 will cover relaxation techniques, and session 5 will reinforce all aspects previously considered.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: COUGH-LESS ProgrammeExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Leicester Cough Questionnaire (LCQ)
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.
Time frame
One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.Secondary outcomes
1
Change in Modified British Medical Research Council Dyspnea Scale (mMRC)
The mMRC has been validated for the Portuguese population and is a predictor of increased severity in people with ILD.
Time frame
One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.2
Change in Cough Visual Analogic Scale (CVAS)
The CVAS will be used to measure intensity and frequency of cough. This scale consists of a 10 cm line ranging from 0 (no severity/intensity) to 10 (extreme severity/intensity) and is moderately responsive.
Time frame
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.3
Change in Chronic Airways Assessment Test (CAAT)
CAT will be used to measure quality of life related to respiratory symptoms. This scale ranges from 0 to 45, where higher values mean a lower quality of life related to respiratory symptoms in people with ILD.
Time frame
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.4
Change in One minute sit-to-stand test (1min-STS)
The 1min-STS will be used to assess functional capacity. It will be counted the maximum number of repetitions completed in 1 minute while sitting and standing on a chair.
Time frame
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.Other outcomes
1
Change in number of hospitalizations
Patients' number of hospitalizations in the previous year and during the follow-up period, as well as the length of stay for each hospitalization, will be assessed by asking the patient to self-report.
Time frame
One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.2
Change in acute exacerbations
Patients' number of acute exacerbations will be assessed by asking the patient to self-report.
Time frame
One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.3
Interstitial Lung Disease- Gender, Age and Physiology model (ILD-GAP model)
ILD-GAP model measures the severity of the disease based on the diagnosis, sex and respiratory function test values to create a score that can vary between 0 and 8. The greater the severity of the disease, the higher the ILD-GAP model.
Time frame
Only one measurement will be assessed on baseline. This will be used as a descriptive measure.Sponsors and contacts
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Aveiro University
Lead sponsor
Fundação para a Ciência e a Tecnologia
Collaborator
Centro Hospitalar do Baixo Vouga
Collaborator
Centro Hospitalar de Entre o Douro e Vouga
Collaborator
Source ClinicalTrials.gov
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