Feasibility Cohort Study on Predictors of Diagnosis and Prognosis of Urine Infection in Care Home Residents: DIagnoSing Care hOme UTI Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- As a feasibility study, there is no primary outcome measure.
研究概览
简要总结
The number of care home residents is increasing and urinary tract infections (UTIs) are common amongst this group. Accurate diagnosis of UTI is important because not treating an infection may lead to serious consequences including death. However, giving antibiotic treatment when there isn't an infection causes side effects and antibiotic resistance, making future infections harder to treat.
Unfortunately, there are several challenges that mean that it is difficult to diagnose UTI accurately in care home residents. Firstly, UTIs don't always cause clear symptoms for people who live in care homes. They sometimes just cause symptoms like confusion which can have lots of different possible causes. Secondly, it may be hard for people living with dementia to say how they are feeling or to easily provide a urine sample. Thirdly, many people who live in care homes have bacteria present in their urine even when they are well, but this not harmful and does not need treatment. Finally, urine tests that are currently available do not give accurate or quick results.
We have thought about some new ways that might help show us if someone in a care home really has a UTI but we don't know yet whether these will work. Our ideas include 1) Working out which symptoms or signs mean a UTI is more likely 2) Detecting new markers of infection in urine samples and 3) Trying out new bedside tests that give rapid results.
For this study we plan to recruit 100 care home residents who will be followed up over 6 months. All 100 participants will provide information and a urine sample at the beginning of the study. 25 of these participants will also provide repeated weekly samples for 4 weeks to look at any changes in the urine over time. Additional information and urine samples will be collected if a participant develops a possible UTI during the study and any treatments will be recorded.
Our findings will be used to develop a funding application for a larger study aiming to improve the diagnosis of UTI in care home residents.
详细描述
This feasibility observational study will be conducted in four overlapping stages: recruiting a cohort of 100 care home residents (CHR) from up to 10 care homes across the Thames Valley and Wessex (Stage 1); collecting weekly repeated baseline urine samples from a subset of participants (without suspected UTI) (Stage 2); following all 100 participants for 6 months and collecting additional data on those who develop possible UTI (Stage 3), and interviewing participants, their families and care home staff about study feasibility and acceptability (Stage 4).
Stage 1 - Cohort recruitment and baseline data collection
Baseline assessments:
Following consent, baseline data will be collected including demographics, medical history, and a description of baseline functional ability. We will also collect a urine sample for baseline microbiological and urinary biomarker analyses for each participant.
Stage 2 - Repeat urine sampling cohort 25 CHR recruited in Stage 1 will be asked to provide weekly urine samples for four weeks. Urine samples will be sent for microbiological and urinary biomarker analyses.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give informed consent for the study, or if lacking capacity, a consultee willing to complete a consultee declaration form.
- •Permanently living in a care home (nursing, residential or mixed).
- •Aged 65 or over.
排除标准
- •Current/recent suspected UTI (within last 4 weeks). However, may be reassessed for eligibility after 4 weeks.
- •Temporary/respite resident (unlikely to remain living in the care home for the 6 months of the study duration)
- •Terminal illness limiting life expectancy such that inclusion would be inappropriate (as judged by care home staff).
- •Known to have a medical condition or be on treatment that is likely to result in severe impairment of the immune system. For example, neutropenia, recent cancer chemotherapy or radiotherapy, or long-term use of oral steroids or other immunosuppressant medication.
- •Experiencing faecal incontinence to the extent that it is impossible to obtain an uncontaminated urine sample (as determined by care home staff).
- •Indwelling urinary catheter or regular use of intermittent catheterisation.
- •Structural urological abnormalities. For example, renal polycystic disease, horseshoe kidney, hydronephrosis, renal hypoplasia
- •Current renal tract malignancy. However, residents with prostate cancer will be eligible if they do not require catheterisation and are not considered terminally ill.
结局指标
主要结局
As a feasibility study, there is no primary outcome measure.
时间窗: Baseline
次要结局
- Proportion of care homes agreeing to participate when recruiting care homes as research sites.(Baseline)
- Quality of urine samples obtained(Through study completion, 6 months)
- Proportion of residents with possible UTI in whom the following is obtained:(Through study completion, 6 months)
- Participant baseline demographic characteristics predictive of subsequent possible UTI/clinical outcomes(Through study completion, 6 months)
- Association of each urinary biomarker with asymptomatic bacteriuria(Baseline)
- Proportion of residents screened that are eligible and proportion of eligible that are recruited.(Baseline)
- Proportion of baseline urine samples obtained from participants recruited (consented)(Baseline)
- Urinary biomarker concentrations in urine samples from possible UTI episodes(Through study completion, 6 months)
- Failure rate of the POCT in residents with possible UTI (no result or invalid result)(Through study completion, 6 months)
- Proportion of repeated urine samples obtained of those participating in Stage 2(2, 3 and 4 weeks)
- Proportion of residents that experience a possible UTI during the follow-up period that are reported to the research team.(Through study completion, 6 months)
- Predictors of weekly sample microbiology and changes in microbiology(Baseline, 2, 3 and 4 weeks)
- Adherence to urine transport protocols(Through study completion, 6 months)
- Proportion of residents with possible UTI that are not reported to the research team.(Assessed weekly through to study completion at 6 months)
- Using semi-structured interviews with qualitative analysis to describe the views of care home staff, participants and family members on:(Through study completion, 6 months)
- Participant clinical characteristics at point of possible UTI and association with clinical outcomes(Through study completion, 6 months)
- Changes in weekly sample microbiology(Baseline, 2, 3 and 4 weeks)
- Association between asymptomatic bacteriuria at baseline or in weekly sampling and onset of possible UTI during follow up period(Through study completion, 6 months)
- Urinary biomarker concentrations in urine samples from asymptomatic participants without bacteriuria(Baseline)
- Agreement between POCT result and laboratory enhanced culture result at symptom onset for each possible UTI episode, and at 28 days post symptom on set(Through study completion, 6 months)