The Minuteful Kidney Test Evaluation: A Randomised Controlled Trial

NCT05967312 | Unknown

• 3 other identifiers: 0849AI_AWARD01813304493
• Study Type: observational
• Target: 163,560
• Locations: 1 country
• Sites: 6

Brief 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

Diabetes; Chronic Kidney Diseases

Keywords

Diabetes

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with a diagnosis of CKD

  At 6 months follow up extraction

• Proportion of patients with ACR test in the last 12 months

  At 6 months follow up extraction (12 months preceding)

Secondary Outcomes (3)

• Proportion of patients with newly diagnosed CKD (i.e., since randomisation)

  Between baseline and 6 months data extraction

• Proportion of patients with albuminuria

  At 6 months follow up extraction

• Proportion of patients with newly diagnosed albuminuria (i.e., since randomisation)

  Between baseline and 6 months data extraction

Study Arms (2)

Intervention:

Offered the Minuteful Kidney Test Kit

Diagnostic Test: Minuteful Kidney Test Kit

Control

Continue as standard of care

Interventions

Minuteful Kidney Test Kit DIAGNOSTIC_TEST

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

Intervention:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Included in the roll out at the time of the trial
• Willing and able to participate
• Willing to be randomised to either intervention or usual care

You may not qualify if:

• Previous involvement with rollout of the Minuteful Kidney Test Kit
• Participant Eligibility Criteria:
• Age \> 18
• Registered with a GP practice involved in the rollout during the time of the evaluation.
• 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:
• Age \> 18 years
• Registered with a GP practice involved in the rollout during the time of the evaluation
• Diagnosed with diabetes (Type I / II)
• Those non-compliant with standard ACR screening practices and eligible for annual tests
• Willing to perform a urine test at home
• Access to a smart phone
• Pregnancy
• Care home residents

Sponsors & Collaborators

• University of Leicester: lead
• NHS Midlands and Lancashire Commissioning Support Unit: collaborator
• NHSE: collaborator

Study Sites (6)

Mid and South Essex (ICB)

Essex, United Kingdom

Location

Leicester, Leicestershire and Rutland (ICB)

Leicester, United Kingdom

Location

North East London (ICB)

London, United Kingdom

Location

South East London (ICB)

London, United Kingdom

Location

North East and North Cumbria (NENC) - ICB

Newcastle, United Kingdom

Location

Somerset (ICB)

Somerset, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: August 1, 2023
• Study Start: November 18, 2022
• Primary Completion: December 1, 2023
• Study Completion: November 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-03

Locations

GB (6)