Evaluation of Health-Related Quality of Life in Adults Hospitalised With Lower Respiratory Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in health state utility values over one year
研究概览
简要总结
Lower respiratory tract infections (LRTIs) are any infections below the vocal cords which affect the airways or the air sacs in the lungs. They include pneumonia, bronchitis and chest infections and are usually caused by viruses such as influenza, COVID-19 or Respiratory Syncytial Virus (RSV), or by bacteria such as pneumococcus. LRTIs are common, particularly in older adults; in the UK approximately 15% of people aged over 65 years will experience a chest infection each year and many of those will need in-patient treatment.
People who have had a chest infection may experience slow recovery after their infection. Patients often report that their quality of life is worse after an infection (for example persistent fatigue, reduced physical functioning, and mental health challenges) and this can affect the return to usual activities. However, there have not been many studies that have looked at how the quality of life changes in the months following a chest infection, and why some people take longer to recover.
In this study, we will use a well-recognised questionnaire to measure quality of life for up to one year in adult who have been admitted to hospital with a chest infection. The findings will help us to assess how long-term quality of life is affected after a chest infection and what factors may affect it. The results will also permit calculation of the costs faced by patients during recovery from a chest infection, in financial terms. These results will feed into studies looking at ways of improving recovery after a chest infection.
详细描述
Acute lower respiratory tract infections (LRTIs) are a group of infections affecting the respiratory tract below the level of the larynx, including pneumonia, acute bronchitis, bronchiolitis, acute infective exacerbations of chronic obstructive pulmonary disease (COPD).
In those who survive their initial episode of LRTI, recovery may be slow with adverse outcomes which may last months or even years after the initial episode and have implications for patients, their families and health care resources. A recent prospective cohort study in the U.S. (PNEUMO) reported that at 6 months after hospitalisation with community-acquired pneumonia (CAP) and compared to their pre-hospitalisation status, 12.8% of participants had lost the ability to perform at least one basic activity of daily living (ADL), 22.0% lost the ability to perform at least one instrumental ADL, 41.6% suffered cognitive impairment, 58.7% had loss of employment, and 23.6% had decreased quality of life (Han et al 2025). Additionally pneumonia patients have high rates of readmission to hospital, which in turn is associated with significant inpatient mortality (Lawrence et al 2023), high rates of primary care consultation within 7 days of discharge (Baskaran et al 2021), increased risk of cardiovascular events and heart failure (Eurich et al 2017; Violi et al 2017), recurrent pneumonia (Baskaran et al 2022) and persistent symptoms (Pick et al 2019).
LRTIs therefore heavily impact patients, their families and carers, and the use of healthcare resources. Measuring the quality of life in patients hospitalised with acute LRTIs for up to one year after their discharge is an important component in the broader assessment of the cost of LRTIs in the UK, but long-term quality of life data in these patients are limited.
Every individual's experience of recovery from pneumonia is unique reflecting the complex interplay between their clinical characteristics, existing co-morbidities, frailty, physical and mental status, illness severity, and underlying causative micro-organism. There are few long-term data on outcomes which are important to patients following an episode of LRTI, including patient-perceived quality of life. It is therefore important to study this outcome and to identify those factors which may be associated with quality-of life measures in order to: a) gain a broader picture of the impact of LRTI on patients themselves; b) inform future trials assessing interventions aimed at improving patients' quality of life; c) to feed into analyses of the health economic costs of LRTIs.
The purpose of this study is to gain a better understanding of how health-related quality of life is affected in people who are hospitalised after a LRTI. The primary objective is to document health states and utility indexes for hospitalised LRTI patients and their evolution over the course of one year after the initial episode. The secondary objective is to evaluate associations between patient characteristics and their hospital stay with their health-related quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18years (no upper age limit).
- •Treated by attending physician as lower respiratory tract infection/community-acquired pneumonia, regardless of microbiologically-confirmed pathogen.
- •Ability to give informed consent or appropriate consultee available to give advice.
排除标准
- •Hospital admission within 14 days preceding the index admission
- •Post-obstructive pneumonia secondary to Lung Cancer
- •Patients treated for active Tuberculosis (TB)
- •Receiving palliative treatment only
- •Unable to understand written or spoken English
- •Presumed to be unable to answer the questionnaires over the follow-up period.
- •Exacerbations of chronic lung disease such as asthma, COPD or bronchiectasis.
- •Previously enrolled in the study.
研究组 & 干预措施
Lower respiratory tract infection
Adults hospitalised with a lower respiratory tract infection (low, moderate or severe severity).
结局指标
主要结局
Change from baseline in health state utility values over one year
时间窗: From enrolment to one year post-discharge from hospital
Health state utility values calculated from EQ-5D-5L profiles using preference-based value sets pre-discharge and at 1, 3, 6 and 12 months post-discharge.
次要结局
未报告次要终点
