Study of Hospitalised Patients With Acute Respiratory Conditions (CHESTY)

Observational Cohort Study of Hospitalised Patients With Acute Respiratory Conditions

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumonia; Asthma; COPD Exacerbation Acute; Acute Respiratory Disease

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.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE3 9QP
    • Glenfield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hospitalised Patients; Participants admitted to hospital with an acute respiratory condition including exacerbation of an underlying physician diagnosed chronic lung disease.
Matched Controls; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of breathlessness using eMRC dyspnoea scale	To evaluate the degree of breathlessness at baseline and following recovery from acute respiratory illness using Extended MRC dyspnoea scale(eMRC). eMRC dyspnoea scale ranges from 1 to 5b with higher score indicates worse outcomes.	52 weeks
Assessment of quality of Life/symptoms using St. George's Respiratory Questionnaire (SGRQ)	St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.	52 weeks

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: University Hospitals, Leicester
• Investigators: Principal Investigator: Neil Greening, PhD, MRCP, NIHR Respiratory Biomedical Research Centre, Leicester

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Pneumonia; Bronchiectasis; Pulmonary Embolism; COPD (Chronic Obstructive Pulmonary Disease); Pleural Diseases; ILD (Interstitial Lung Diseases)
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Lung Diseases; Pneumonia; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 0822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No