Aged European Population QUality of Life in Infectious Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 521
- 试验地点
- 22
- 主要终点
- Evolution of Functional dependency
研究概览
简要总结
The increasing number of persons >65 years of age form a special population at risk for nosocomial and other health care-associated infections. The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture. The magnitude and diversity of health care-associated infections in the aging population are generating new arenas for prevention and control efforts.
Common infections leading to hospitalizations in this age group result in respiratory infections and bacteraemia and the impact of these infections on the quality of life and disability in aged populations has not been accurately quantified in a European setting.
This study aims to capture and quantify the impact of infectious diseases on quality of life in an aged population.
详细描述
An emerging public health challenge is to protect the growing ageing population from infectious diseases, which can significantly impact the quality of life of those affected.
The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture.
The increasing number of persons >65 years of age form a special population at risk for nosocomial and other health care-associated infections. The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture. The magnitude and diversity of health care-associated infections in the aging population are generating new arenas for prevention and control efforts.
Common infections leading to hospitalizations in this age group result in respiratory infections and bacteraemia and the impact of these infections on the quality of life in aged populations has not been accurately quantified in a European setting.
This study aims to capture and quantify the impact of infectious diseases on quality of life in an aged population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized adults 65 years or older,
- •Presenting with bacteremia with positive blood culture (excluding catheter related infections) and/or
- •WHO Severe Acute Respiratory Infection (SARI) case definition
- •Upper respiratory infection = SARI (fever or history of fever >38°C, cough, onset of the disease within the last 10 days and requires hospitalisation)
- •Lower respiratory infection = SARI with confirmed CT/CHR
- •Informed consent form signed
- •Patient affiliated to social security insurance
排除标准
- •Bedridden or terminally ill patient (based upon a threshold of ADL: ≤2 TBD, or CLINICAL FRAILTY SCALE: ≥8 )
- •Patients that refuse the 3- and 6-months follow-up phone call assessments
- •Patients that will not be able to answer the 3- and 6-months follow-up phone call assessments via a nurse
- •Subject in exclusion period for another study,
- •Subject who cannot be contacted in an emergency
- •Persons referred to in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
- •Inclusion Criteria For Controls
- •Same age (+/- 3 years)
- •same sex,
- •without suspicion of infection
- •Hospitalized during the past or upcoming month in the same centre.
- •Informed consent form signed
- •Patient affiliated to social security insurance
- •Exclusion Criteria For Controls
- •Bedridden or terminally ill patient (based upon a threshold of ADL: ≤2 TBD, or CLINICAL FRAILTY SCALE: ≥8 )
- •Patients that refuse the 3- and 6-months follow-up phone call assessments
- •Patients that will not be able to answer the 3- and 6-months follow-up phone call assessments via a nurse
- •Subject in exclusion period for another study,
- •Subject who cannot be contacted in an emergency
- •Persons referred to in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure)
结局指标
主要结局
Evolution of Functional dependency
时间窗: Baseline and at 6 months
Change in activities of daily living (ADL) (Scores ADL : 6/6, 0 to 6, best is 6)
次要结局
- Functional status depending on the infectious causes.(15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge)
- Evolution of Frailty(15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge)
- Change frailty per country and per health care setting(15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge)
- Microbial Epidemiology(At 6 months)
- Change in Functional status per country and per health care setting(15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge)
- Evolution of quality of life depending on the infectious causes.(15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge])
- Evolution of Frailty on depending on the infectious causes.(15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge)
- Medical complications(acute phase, Up to 10 days, at 3 months and at 6 months)
- Evolution of quality of life(15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge)