Actively Recruiting
Feasibility Cohort Study on Predictors of Diagnosis and Prognosis of Urine Infection in Care Home Residents: DIagnoSing Care hOme UTI Study
Led by University of Southampton · Updated on 2024-07-31
100
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
U
University of Southampton
Lead Sponsor
U
University of Oxford
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve diagnosis of urinary tract infections (UTIs) in care home residents, a group where UTIs are common but often difficult to identify accurately. UTIs may cause subtle or unclear symptoms, especially in people with dementia, and current urine tests are not quick or accurate. Misdiagnosis can lead to serious health issues or unnecessary antibiotic use, which risks side effects and antibiotic resistance. The study will recruit 100 care home residents aged 65 or older and follow them for six months. Participants will provide baseline information and urine samples, with a subgroup of 25 providing weekly samples for four weeks to observe changes over time. If a participant develops possible UTI, additional samples and assessments will be collected, including testing with new point-of-care tests (POCTs) that aim to give rapid results. Participants will be monitored regularly, and data on symptoms, urine test results, and treatments will be collected. The study also includes interviews with residents, families, and care staff to assess the study's feasibility and acceptability. The findings will support future research aimed at better diagnosing UTIs in care home residents.
CONDITIONS
Brief Title
DIagnoSing Care hOme UTI Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give informed consent, or if lacking capacity, have a consultee willing to complete a declaration form
- Permanently living in a care home (nursing, residential, or mixed)
- Aged 65 years or older
You will not qualify if you...
- Current or recent suspected UTI within the last 4 weeks (may be reassessed after 4 weeks)
- Temporary or respite resident unlikely to remain in the care home for 6 months
- Terminal illness limiting life expectancy as judged by care home staff
- Medical condition or treatment causing severe immune system impairment (e.g., neutropenia, recent chemotherapy/radiotherapy, long-term steroids or immunosuppressants)
- Faecal incontinence preventing uncontaminated urine sample collection
- Presence of indwelling urinary catheter or regular intermittent catheterisation
- Structural urological abnormalities (e.g., renal polycystic disease, horseshoe kidney, hydronephrosis, renal hypoplasia)
- Current renal tract malignancy (prostate cancer allowed if no catheter and not terminally ill)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants are recruited and baseline data including demographics, medical history, and urine samples are collected. A subset provides weekly urine samples for four weeks to monitor urinary biomarkers and microbiology.
Weekly visits for up to 4 weeks for a subset of participants
Duration - 6 months
All participants are followed for 6 months. Care home staff alert the research team if participants develop possible UTI, triggering additional assessments.
Ongoing monitoring with 3 visits (at symptom onset, 14 days, and 28 days) for participants who develop possible UTI
Duration - Up to 28 days per UTI episode
Participants who develop possible UTI have urine samples collected and are assessed using novel point-of-care tests before treatment when possible.
3 visits per UTI episode (baseline, 14 days, and 28 days)
Duration - During study completion period
Towards the end of the study, participants, their families, and care home staff are invited to participate in interviews to explore study acceptability and barriers.
1 or more interviews per participant or staff member
Trial Site Locations
Total: 1 location
1
Solent NHS Trust
Southampton, United Kingdom
Actively Recruiting
Research Team
A
Abigail Moore
N
Nick Francis
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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