An observational study in Diabetes and Chronic Kidney Diseases, sponsored by University of Leicester. Status unknown at 6 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by University of Leicester · Observational
Chronic Kidney Disease (CKD) is a long-term condition in which the ability of the kidneys to function gets worse over time. People with CKD often do not have associated symptoms, meaning that it is possible for the condition to go undetected until the condition worsens and symptoms develop. The disease is more common in people with diabetes and screening by means of urine and blood tests is recommended in this population by The National Institute for Health and Care Excellence (NICE) Guidelines in order to detect disease earlier. However, screening rates amongst these patients are low and the dilemma is therefore how to increase the rate of screening in those who are ordinarily non-compliant. It is thought that facilitating patients in being able to perform The Minuteful Kidney Test (an at home test using smartphone technology) may increase the amount of people that undertake the test and thus improving early detection. 348 GP practices will be randomised in clusters, meaning that the GP practice will be randomised rather than the individual patient. This type of trial design is common in public health research as it is particularly suited to testing differences in approaches towards patient care. Each cluster will consist of on average 470 patients with diabetes. Each cluster will be allocated at random to either issuing The Minuteful Kidney Test (plus usual care) or usual care alone. This allocation will be applicable to each patient within that cluster. The evaluation will tell us whether administering this test increases the diagnosis rates of CKD as well as the frequency at which the test is performed in patients with diabetes. The results of the evaluation will determine whether The Minuteful Kidney Test should be used instead of or alongside existing blood and urine tests in this particular group of patients.
The National CKD Audit (2017) (1) identified that 11 million people in the UK are at risk of chronic kidney disease (CKD), a long-term irreversible deterioration in kidney function with occurrence being more common in those with diabetes. NICE CG182 and NICE QS05 define testing Albumin:Creatinine ratio (ACR) in at risk populations as critical from a clinical and cost point of view. Despite its importance in the prevention of kidney disease, ACR testing is the worst performing of all 9 NICE diabetes care processes with low screening rates among patients, making this a critical area for improvement. Home testing strategies may therefore be useful in improving proteinuria screening adherence, which the National CKD Audit (2017) (1) finding that up to 65% of people with diabetes have relevant annual urinary ACR tests.
The overarching aim of The Minuteful Kidney Test Evaluation
Using a Cluster RCT design, randomisation will operate on a 1:1 basis with a 50% chance of a cluster being allocated to the intervention. 348 practices (clusters) are required, with one cluster added to each arm to account for any whole cluster drop out. The average cluster size will consist of 470 patients with DM, determined as constant by how many patients with DM are eligible for annual review. 348 GP practices would provide 80% power at the 5% significance level to detect an increase in rate of CKD from 3% in the control arm to 4.3% in the intervention arm. This would provide over 90% power at the 5% significance level to detect an absolute increase of 7% in ACR test rate in the intervention arm compared to control (65% to 72%). The calculations assumed an ICC of 0.05, a coefficient of variation to allow for variation in in cluster size of 0.128 (cluster size range of 360-600).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 163,560 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Leicester is the lead sponsor of 166 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The trial population are GP registered patients with a diabetes diagnosis in GP records where the GP practice delivers routine annual screening for CKD via an ACR test based on an anniversary date and follows-up patients with increased albuminuria to confirm a diagnosis of CKD. Eligible GP practices will be recruited to participate in the trial.
GP Practice Eligibility Criteria:
Inclusion Criteria
Participant Eligibility Criteria:
Inclusion Criteria
Eligibility Criteria to be offered the Minuteful Kidney Test Kit (for individuals in practices randomised to intervention only)
In intervention practices only individuals who satisfy all the criteria will be offered the Minuteful Kidney Test Kit:
Inclusion Criteria
Additional Qualitative Process Evaluation Eligibility Criteria (for individuals in practices randomised to intervention only) :
Inclusion Criteria
Offered the Minuteful Kidney Test Kit
Diagnostic Test: Minuteful Kidney Test Kit
Continue as standard of care
The Minuteful Kidney Test is an Artificial Intelligence (AI) based innovative technology to enable people at risk of CKD to undertake an ACR test at home using smartphone technology
Proportion of patients with a diagnosis of CKD
Time frame: At 6 months follow up extraction
Proportion of patients with ACR test in the last 12 months
Time frame: At 6 months follow up extraction (12 months preceding)
Proportion of patients with newly diagnosed CKD (i.e., since randomisation)
Time frame: Between baseline and 6 months data extraction
Proportion of patients with albuminuria
Time frame: At 6 months follow up extraction
Proportion of patients with newly diagnosed albuminuria (i.e., since randomisation)
Time frame: Between baseline and 6 months data extraction
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University of Leicester