Status:
UNKNOWN
The Minuteful Kidney Test Evaluation: A Randomised Controlled Trial
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
NHS Midlands and Lancashire Commissioning Support Unit
NHSE
Conditions:
Diabetes
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
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 po...
Detailed Description
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 bei...
Eligibility Criteria
Inclusion
- GP Practice Eligibility Criteria:
- Inclusion Criteria
- 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
- Willing to provide the necessary trial data extractions and allow the research team access to staff for qualitative elements of the research Exclusion Criteria
- Previous involvement with rollout of the Minuteful Kidney Test Kit
- Participant Eligibility Criteria:
- Inclusion Criteria
- Age \> 18
- Registered with a GP practice involved in the rollout during the time of the evaluation.
- Diagnosed with diabetes (Type I / II) Exclusion Criteria
- 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
- 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
- An ability to understand written English Exclusion Criteria
- Pregnancy
- Care home residents
- Patients who are catheterised
- 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
- Willing and able to provide informed consent
- At home Minuteful Kidney Test received
- Willing and able to provide verbal consent for interview
- An ability to understand verbal and written English or access to language support through family and/or friends
Exclusion
Key Trial Info
Start Date :
November 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
163560 Patients enrolled
Trial Details
Trial ID
NCT05967312
Start Date
November 18 2022
End Date
November 1 2024
Last Update
August 1 2023
Active Locations (6)
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1
Mid and South Essex (ICB)
Essex, United Kingdom
2
Leicester, Leicestershire and Rutland (ICB)
Leicester, United Kingdom
3
North East London (ICB)
London, United Kingdom
4
South East London (ICB)
London, United Kingdom