The Minuteful Kidney Test Evaluation: A Randomised Controlled Trial
Trial ID: NCT05967312
Status: UNKNOWN
Study type: OBSERVATIONAL
Start date: 2022-11-18
Completion date: 2024-11
Sponsor: University of Leicester
Collaborators: NHS Midlands and Lancashire Commissioning Support Unit; NHSE
Conditions: Diabetes; Chronic Kidney Diseases
Interventions: Minuteful Kidney Test Kit
Locations: Mid and South Essex (ICB); Leicester, Leicestershire and Rutland (ICB); North East London (ICB); South East London (ICB); North East and North Cumbria (NENC) - ICB; Somerset (ICB)
Countries: United Kingdom; United Kingdom; United Kingdom; United Kingdom; United Kingdom; United Kingdom
Enrollment: 163560
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
GP Practice Eligibility Criteria:

Inclusion Criteria

1. Included in the roll out at the time of the trial
2. Willing and able to participate
3. Willing to be randomised to either intervention or usual care
4. Willing to provide the necessary trial data extractions and allow the research team access to staff for qualitative elements of the research Exclusion Criteria
5. Previous involvement with rollout of the Minuteful Kidney Test Kit

Participant Eligibility Criteria:

Inclusion Criteria

1. Age \> 18
2. Registered with a GP practice involved in the rollout during the time of the evaluation.
3. Diagnosed with diabetes (Type I / II) Exclusion Criteria
4. National Data Opt-out of sharing for anything other than clinical care

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

1. Age \> 18 years
2. Registered with a GP practice involved in the rollout during the time of the evaluation
3. Diagnosed with diabetes (Type I / II)
4. Those non-compliant with standard ACR screening practices and eligible for annual tests
5. Willing to perform a urine test at home
6. Access to a smart phone
7. An ability to understand written English Exclusion Criteria
8. Pregnancy
9. Care home residents
10. Patients who are catheterised
11. Patients who are on the end-of-life care pathway

Additional Qualitative Process Evaluation Eligibility Criteria (for individuals in practices randomised to intervention only) :

Inclusion Criteria

1. Willing and able to provide informed consent
2. At home Minuteful Kidney Test received
3. Willing and able to provide verbal consent for interview
4. An ability to understand verbal and written English or access to language support through family and/or friends

Outcomes:
Proportion of patients with a diagnosis of CKD; Proportion of patients with ACR test in the last 12 months