Study of Hospitalised Patients With Acute Respiratory Conditions

Study Overview
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Brief Summary
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This observational study aim to characterise patients admitted to hospital with an acute respiratory condition, or acute worsening of their chronic lung condition. This will enable identification of predictors of future risk, as well as develop potential interventions targets.

Detailed Description
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This will be an observational cohort study, recruiting patients who have been admitted to hospital with an acute respiratory condition. This can include exacerbation of an existing chronic lung disease such as asthma, COPD, interstitial lung disease, bronchiectasis and pleural disease, or contracting an acute illness including pulmonary embolism, pneumonia, or any other respiratory infection. The patients will be screened and recruited whilst still hospitalised and followed up for one year after discharge. The participants will undergo a baseline study visit while in hospital, with the option to have further follow up visits (up to three occasions) in the following year to assess clinical recovery. The participants will be offered the choice to undertake the follow up assessments via any of the following routes: a telephone consultation or a face to face visit either in the Biomedical Research Centre (BRC) or during a research visit from another ethically approved study or during routine clinical follow up organised by the hospital clinical team. The participants can choose not to attend any further follow up visits after discharge. Any planned clinical follow-up arranged by the hospital team will occur according to clinical needs. If the participant is re-admitted during the 12 months after enrolment, assessments identical to the baseline visit can be repeated. A final remote visit will be carried out at 12 months post-discharge (+/- 1 month) to collect data about health care utilisation (e.g. hospitalisation rate, length of stay in hospital, death rate, antibiotic/steroid prescriptions) from both primary and secondary healthcare records. The participants are not required to attend this final visit as data will be collected remotely.

Official Title
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Observational Cohort Study of Hospitalised Patients With Acute Respiratory Conditions

Conditions
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Asthma, Acute Respiratory Disease, COPD Exacerbation Acute, Pneumonia

Participation Criteria
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Eligibility Criteria
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Hospitalised Patients Inclusion Criteria: Hospital admission with an acute respiratory diagnosis Participant is willing & able to give informed consent for participation in the study Aged 18 years or above Able (in the Investigators opinion) & willing to comply with all study requirements Exclusion Criteria: Unstable or life-threatening cardiac disease including myocardial infarction or unstable angina during current admission. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. Known pregnancy Matched Controls Inclusion Criteria: Aged 18 years or above Patients with stable chronic respiratory conditions or healthy volunteers Able (in the Investigators opinion) & willing to comply with all study requirements 7.3.2 Exclusion Criteria: Hospitalised due to an acute respiratory illness in the last 6 weeks prior to consent Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. Known pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalised Patients<br>Participants admitted to hospital with an acute respiratory condition including exacerbation of an underlying physician diagnosed chronic lung disease. | |
| Matched Controls<br>The study will include matched controls (non-hospitalised patients with stable chronic respiratory conditions or healthy volunteers) to compare the exploratory endpoints. The number of the matched controls will not exceed 25% of the main study recruitment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days hospital re-admission rate | To calculate the percentage of readmission due to the same acute respiratory illness within 30 days from consent | 30 days | 
| Length of index hospital admission stay | To calculate the length of the index hospital stay | Variable (up to 52 weeks) | 
| 30 days mortality rate | To calculate the percentage of mortality within 30 days from consent | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of hospital readmission due to same underlying chronic lung disease. | To evaluate the number of hospital readmission episodes due to same underlying chronic lung disease over a 52 weeks period. | 52 weeks | 
| Total number of non-hospitalised exacerbations of underlying chronic lung disease | To evaluate the number of non-hospitalised exacerbations of chronic lung disease e.g. asthma, Chronic Obstructive Pulmonary Diseases (COPD), etc. over 52 weeks | 52 weeks | 
| Time from consent to death (respiratory causes and all causes) | To measure the time from consent to death within 52 weeks from consent. This will include both respiratory and all causes of mortality | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Asthma, COPD (Chronic Obstructive Pulmonary Disease), ILD (Interstitial Lung Diseases), Pulmonary Embolism, Pleural Diseases, Bronchiectasis