Clinical trial NCT05095090: Study of Hospitalised Patients With Acute Respiratory Conditions
Official title: Observational Cohort Study of Hospitalised Patients With Acute Respiratory Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Disease
COPD Exacerbation Acute
Asthma
Pneumonia
Keywords: Asthma
COPD (Chronic Obstructive Pulmonary Disease)
Pneumonia
ILD (Interstitial Lung Diseases)
Pulmonary Embolism
Pleural Diseases
Bronchiectasis
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2021-10-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants admitted to hospital with an acute respiratory condition including exacerbation of an underlying physician diagnosed chronic lung disease. The study will include matched controls (non-hospitalised patients with stable chronic respiratory conditions or healthy volunteers). Co-participation in other ethically approved studies including interventional trials is permissible.

Brief summary: 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: 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.

Eligibility criteria: Hospitalised Patients

Inclusion Criteria:

1. Hospital admission with an acute respiratory diagnosis
2. Participant is willing \& able to give informed consent for participation in the study
3. Aged 18 years or above
4. Able (in the Investigators opinion) \& willing to comply with all study requirements

Exclusion Criteria:

1. Unstable or life-threatening cardiac disease including myocardial infarction or unstable angina during current admission.
2. 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.
3. Known pregnancy

Matched Controls

Inclusion Criteria:

1. Aged 18 years or above
2. Patients with stable chronic respiratory conditions or healthy volunteers
3. Able (in the Investigators opinion) \& willing to comply with all study requirements

7.3.2 Exclusion Criteria:

1. Hospitalised due to an acute respiratory illness in the last 6 weeks prior to consent
2. 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.
3. Known pregnancy

Primary outcomes:
measure: 30 days hospital re-admission rate
timeFrame: 30 days
measure: Length of index hospital admission stay
timeFrame: Variable (up to 52 weeks)
measure: 30 days mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: Total number of hospital readmission due to same underlying chronic lung disease.
timeFrame: 52 weeks
measure: Total number of non-hospitalised exacerbations of underlying chronic lung disease
timeFrame: 52 weeks
measure: Time from consent to death (respiratory causes and all causes)
timeFrame: 52 weeks
Other outcomes:
measure: Assessment of breathlessness using eMRC dyspnoea scale
timeFrame: 52 weeks
measure: Assessment of quality of Life/symptoms using St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 52 weeks
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
Study officials:
affiliation: NIHR Respiratory Biomedical Research Centre, Leicester
name: Neil Greening, PhD, MRCP
role: PRINCIPAL_INVESTIGATOR
References: