Observational Cohort Study of Hospitalised Patients With Acute Respiratory Conditions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- 30 days mortality rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hospital admission with an acute respiratory diagnosis
- •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
排除标准
- •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
- •Matched Controls
- •Inclusion Criteria:
- •Aged 18 years or above
- •Patients with stable chronic respiratory conditions or healthy volunteers
- •Able (in the Investigators opinion) & willing to comply with all study requirements
- •7.3.2 Exclusion Criteria:
- •Hospitalised due to an acute respiratory illness in the last 6 weeks prior to consent
- •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
结局指标
主要结局
30 days mortality rate
时间窗: 30 days
To calculate the percentage of mortality within 30 days from consent
30 days hospital re-admission rate
时间窗: 30 days
To calculate the percentage of readmission due to the same acute respiratory illness within 30 days from consent
Length of index hospital admission stay
时间窗: Variable (up to 52 weeks)
To calculate the length of the index hospital stay
次要结局
- Total number of hospital readmission due to same underlying chronic lung disease.(52 weeks)
- Total number of non-hospitalised exacerbations of underlying chronic lung disease(52 weeks)
- Time from consent to death (respiratory causes and all causes)(52 weeks)