Study of Hospitalised Patients With Acute Respiratory Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity of Leicester
About this trial
The goal of this observational study is to learn about the short- and long-term outcomes of people admitted to hospital with an acute respiratory condition, including exacerbations of chronic lung disease, and to understand factors that may predict recovery, hospital readmission, length of hospital stay, and mortality. A group of people with chronic respiratory disease who are being followed in respiratory outpatient clinics and a healthy control group without lung disease will also take part.
The main questions it aims to answer are:
* Which clinical, physical, functional, and biological characteristics are associated with short-term outcomes after hospitalisation, including 30-day hospital readmission, length of hospital stay, and 30-day mortality? * Which characteristics are associated with longer-term recovery, future exacerbations, hospital readmissions, healthcare use, and mortality? * Can measurements taken during or around the time of hospitalisation be used to identify people at greater risk of poor outcomes who may benefit from targeted interventions?
Participants will undergo clinical assessments that may include questionnaires, measurements of physical function and muscle strength, lung function tests, physical activity monitoring, and collection of biological samples. Some participants may also undergo additional assessments of body composition, muscle size and function, imaging, or muscle metabolism, including through nested sub-studies. Participants will be followed for up to 36 months to assess recovery and longer-term clinical outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Hospital admission with an acute respiratory diagnosis, or currently under the care of hospital respiratory outpatient services for a chronic respiratory disease
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
Disqualifiers
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
Aged 18 years or above
Trial population
Participants will include adults admitted to hospital with an acute respiratory condition, including exacerbations of an underlying physician-diagnosed chronic respiratory disease, as well as non-hospitalised patients under respiratory outpatient follow-up for a chronic respiratory condition. The study will also include healthy volunteers without chronic respiratory disease as a comparator group. Co-participation in other ethically approved studies, including interventional trials, is permitted.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: Hospitalised Patients
Group B: Matched Controls (stable COPD and healthy volunteers)
Trial outcomes
Primary outcomes
1
30 days hospital re-admission rate
To calculate the percentage of readmission due to the same acute respiratory illness within 30 days from consent
Time frame
30 days2
Length of index hospital admission stay
To calculate the length of the index hospital stay
Time frame
Variable (up to 52 weeks)3
30 days mortality rate
To calculate the percentage of mortality within 30 days from consent
Time frame
30 daysSecondary outcomes
1
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.
Time frame
52 weeks2
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
Time frame
52 weeks3
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
Time frame
52 weeksOther outcomes
1
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.
Time frame
52 weeks2
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.
Time frame
52 weeksSponsors and contacts
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University of Leicester
Lead sponsor
University Hospitals, Leicester
Collaborator
Source ClinicalTrials.gov