Interstitial lung disease Respiratory
Conditions
Interventions
This is a feasibility multi-centre study to assess the feasibility of CCT for people with ILD and chronic cough. The study will recruit 50 participants with a diagnosis of fibrotic ILD and chronic cou
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adults (>=18 years old) with a confirmed diagnosis of Fibrotic Interstitial Lung Disease on high resolution CT 3, defined as reticular abnormality with traction bronchiectasis, with or without honeycombing, with symptomatic fibrotic disease) and chronic cough lasting >=8 weeks. 2. Patients with signs or symptoms for co-morbidities associated known to be associated with chronic cough should be treated prior to the inclusion of the study. 3. Participants able to access and use technology required for the virtual sessions. 4. Patients on a stable dose of MST for at least a month and still have a patient reported troublesome cough to warrant treatment.
Exclusion criteria
Exclusion criteria: 1. Upper or lower respiratory tract infection in past 2 months. 2. Currently taking or a history of ACE-inhibitor medications in the past 3 months (which can cause chronic cough). 3. Current smokers (cigarettes or e-cigarettes, self-reported). 4. Respiratory disease other than fibrotic interstitial lung disease e.g. COPD or bronchiectasis. 5. Currently or due to participate in pulmonary rehabilitation or receiving Physiotherapy/speech and language therapy for chronic cough or breathing pattern dysfunction in the next four months (as there is cross over of some of the breathing techniques taught in pulmonary rehabilitation and cough control therapy which may affect results). 6. Patients who have started new antifibrotic medication for their ILD <8 weeks duration. 7. Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and acceptability assessed using: 1. Number of eligible patients and number recruited (target recruitment is 6 participants per month (3 per site) over 9-month recruitment period (Objective 1) 2. Rate of retention in the trial measured at end of study 3. Intervention fidelity and adherence assessed using physiotherapist-completed case report forms and patient-completed diaries for the interventions, measured at end of study 4. Response rates to questionnaires and outcome measures measured at beginning and end of study 5. Rate of completion of health-care resource use via patient diaries (appointments with healthcare clinicians, medication use) measured at end of study 6. Participants’ acceptability, views about the intervention and reasons for non-completion via qualitative interviews, measured at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cough-related quality of life assessed using Leicester cough questionnaire (LCQ) at baseline, end of treatment and follow up (Objective 6) 2. ILD health-related quality of life assessed using the King’s Brief Interstitial Lung Disease (KBILD) at baseline, end of treatment and follow up (Objective 6) 3. Cough frequency assessed using the VitaloJak Cough monitor (a cough recording device worn for 24 hours) at baseline and end of treatment (Objective 6) 4. Cough severity assessed using the visual analogue scale (VAS) at baseline, end of treatment and follow up (Objective 6) 5. Anxiety/depression assessed using the generalised anxiety disorder assessment (GAD-7) and Patient Health Questionnaire (PHQ-9) at baseline, end of treatment and follow up (Objective 6) 6. Dyspnoea assessed using Dyspnea-12 (D-12) at baseline, end of treatment and follow up (Objective 6) 7. Breathing pattern assessed using the Breathing Pattern Assessment Tool (BPAT) by the treating physiotherapists at participant’s first treatment session (Visit 2) and last treatment session (Visit 5) (Objective 6) 8. Cost-effectiveness measured using the EuroQoL-5D (EQ-5D) at baseline, end of treatment and follow up (Objective 7) 9. Healthcare resource use measured using the Modular Resource-use Measure (ModRum) at end of treatment and follow up (Objective 7) 10. Number and type of adverse events recorded at every treatment session (Objective 5) | — |
Countries
England, United Kingdom
Contacts
Public ContactConal Hayton
Outcome results
None listed