CHESTY: Study of Hospitalised Patients With Acute Respiratory Conditions

Sponsor
University of Leicester (Other)
Overall Status
Recruiting
CT.gov ID
NCT05095090
Collaborator
University Hospitals, Leicester (Other)
300
1
26.9
11.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Observational Cohort Study of Hospitalised Patients With Acute Respiratory Conditions
    Actual Study Start Date :
    Feb 2, 2022
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Apr 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 30 days hospital re-admission rate [30 days]

      To calculate the percentage of readmission due to the same acute respiratory illness within 30 days from consent

    2. Length of index hospital admission stay [Variable (up to 52 weeks)]

      To calculate the length of the index hospital stay

    3. 30 days mortality rate [30 days]

      To calculate the percentage of mortality within 30 days from consent

    Secondary Outcome Measures

    1. Total number of hospital readmission due to same underlying chronic lung disease. [52 weeks]

      To evaluate the number of hospital readmission episodes due to same underlying chronic lung disease over a 52 weeks period.

    2. Total number of non-hospitalised exacerbations of underlying chronic lung disease [52 weeks]

      To evaluate the number of non-hospitalised exacerbations of chronic lung disease e.g. asthma, Chronic Obstructive Pulmonary Diseases (COPD), etc. over 52 weeks

    3. Time from consent to death (respiratory causes and all causes) [52 weeks]

      To measure the time from consent to death within 52 weeks from consent. This will include both respiratory and all causes of mortality

    Other Outcome Measures

    1. Assessment of breathlessness using eMRC dyspnoea scale [52 weeks]

      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.

    2. Assessment of quality of Life/symptoms using St. George's Respiratory Questionnaire (SGRQ) [52 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glenfield Hospital Leicester United Kingdom LE3 9QP

    Sponsors and Collaborators

    • University of Leicester
    • University Hospitals, Leicester

    Investigators

    • Principal Investigator: Neil Greening, PhD, MRCP, NIHR Respiratory Biomedical Research Centre, Leicester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Leicester
    ClinicalTrials.gov Identifier:
    NCT05095090
    Other Study ID Numbers:
    • 0822
    First Posted:
    Oct 27, 2021
    Last Update Posted:
    Feb 28, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Leicester
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2022