Study of Hospitalised Patients With Acute Respiratory Conditions

NCT ID: NCT05095090

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2024-04-30

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.

Conditions

Acute Respiratory Disease; COPD Exacerbation Acute; Asthma; Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hospitalised Patients

Participants admitted to hospital with an acute respiratory condition including exacerbation of an underlying physician diagnosed chronic lung disease.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Greening, PhD, MRCP

Role: PRINCIPAL_INVESTIGATOR

NIHR Respiratory Biomedical Research Centre, Leicester

Locations

Glenfield Hospital

Leicester, , United Kingdom

Countries

United Kingdom

Other Identifiers

0822

Identifier Type: -

Identifier Source: org_study_id