MedTrace Logo

The Minuteful Kidney Test Evaluation: A Randomised Controlled Trial

NCT05967312 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 163560

Last updated 2023-08-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Minuteful Kidney Test Kit

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

Sponsors & Collaborators

  • NHS Midlands and Lancashire Commissioning Support Unit

    collaborator UNKNOWN

  • NHSE

    collaborator UNKNOWN

  • University of Leicester

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2023-12-31
Completion
2024-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05967312 on ClinicalTrials.gov