MKT_EVAL

  • Research type

    Research Study

  • Full title

    The Minuteful Kidney test Evaluation: A Randomised Controlled Trial

  • IRAS ID

    304493

  • Contact name

    Gavin Murphy

  • Contact email

    gjm19@leicester.ac.uk

  • Sponsor organisation

    University of Leicester

  • Clinicaltrials.gov Identifier

    NCT05967312

  • Duration of Study in the UK

    1 years, 8 months, 31 days

  • Research 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.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    22/NW/0123

  • Date of REC Opinion

    27 Jun 2022

  • REC opinion

    Further Information Favourable Opinion