xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05967312</url>
    </required_header>
    <id_info>
      <org_study_id>0849</org_study_id>
      <secondary_id>AI_AWARD01813</secondary_id>
      <secondary_id>304493</secondary_id>
      <nct_id>NCT05967312</nct_id>
    </id_info>
    <brief_title>The Minuteful Kidney Test Evaluation: A Randomised Controlled Trial</brief_title>
    <acronym>MKT_Eval</acronym>
    <official_title>The Minuteful Kidney Test Evaluation: A Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Leicester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>NHS Midlands and Lancashire Commissioning Support Unit</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>NHSE</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Leicester</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Chronic Kidney Disease (CKD) is a long-term condition in which the ability of the kidneys to&#xD;
        function gets worse over time. People with CKD often do not have associated symptoms, meaning&#xD;
        that it is possible for the condition to go undetected until the condition worsens and&#xD;
        symptoms develop. The disease is more common in people with diabetes and screening by means&#xD;
        of urine and blood tests is recommended in this population by The National Institute for&#xD;
        Health and Care Excellence (NICE) Guidelines in order to detect disease earlier. However,&#xD;
        screening rates amongst these patients are low and the dilemma is therefore how to increase&#xD;
        the rate of screening in those who are ordinarily non-compliant. It is thought that&#xD;
        facilitating patients in being able to perform The Minuteful Kidney Test (an at home test&#xD;
        using smartphone technology) may increase the amount of people that undertake the test and&#xD;
        thus improving early detection. 348 GP practices will be randomised in clusters, meaning that&#xD;
        the GP practice will be randomised rather than the individual patient. This type of trial&#xD;
        design is common in public health research as it is particularly suited to testing&#xD;
        differences in approaches towards patient care. Each cluster will consist of on average 470&#xD;
        patients with diabetes. Each cluster will be allocated at random to either issuing The&#xD;
        Minuteful Kidney Test (plus usual care) or usual care alone. This allocation will be&#xD;
        applicable to each patient within that cluster. The evaluation will tell us whether&#xD;
        administering this test increases the diagnosis rates of CKD as well as the frequency at&#xD;
        which the test is performed in patients with diabetes. The results of the evaluation will&#xD;
        determine whether The Minuteful Kidney Test should be used instead of or alongside existing&#xD;
        blood and urine tests in this particular group of patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The National CKD Audit (2017) (1) identified that 11 million people in the UK are at risk of&#xD;
        chronic kidney disease (CKD), a long-term irreversible deterioration in kidney function with&#xD;
        occurrence being more common in those with diabetes. NICE CG182 and NICE QS05 define testing&#xD;
        Albumin:Creatinine ratio (ACR) in at risk populations as critical from a clinical and cost&#xD;
        point of view. Despite its importance in the prevention of kidney disease, ACR testing is the&#xD;
        worst performing of all 9 NICE diabetes care processes with low screening rates among&#xD;
        patients, making this a critical area for improvement. Home testing strategies may therefore&#xD;
        be useful in improving proteinuria screening adherence, which the National CKD Audit (2017)&#xD;
        (1) finding that up to 65% of people with diabetes have relevant annual urinary ACR tests.&#xD;
  &#xD;
        The overarching aim of The Minuteful Kidney Test Evaluation&#xD;
  &#xD;
          -  https://healthy.io/services/kidney&#xD;
  &#xD;
          -  https://www.nhsx.nhs.uk/ai-lab/explore-all-resources/understand-ai/healthyio-smartphone-&#xD;
             albuminuria-urine-self-testing/ is to increase the use of ACR testing to identify&#xD;
             previously undiagnosed albuminuria in those with diabetes. The primary hypothesis is&#xD;
             that there will be an increase in proportion of individuals screened in general&#xD;
             practices utilising the Minuteful Kidney Test (plus usual care) compared with general&#xD;
             practices delivering usual care alone; and that this will result in a higher proportion&#xD;
             of previously undiagnosed CKD being diagnosed in individuals in the intervention&#xD;
             practices. The suitability of the technology for widescale deployment will also be&#xD;
             addressed by exploring differences in outcomes by baseline characteristics alongside the&#xD;
             qualitative process evaluation which will also gain an understanding of the technology's&#xD;
             application across the UK population through a mixed method evaluation.&#xD;
  &#xD;
        Using a Cluster RCT design, randomisation will operate on a 1:1 basis with a 50% chance of a&#xD;
        cluster being allocated to the intervention. 348 practices (clusters) are required, with one&#xD;
        cluster added to each arm to account for any whole cluster drop out. The average cluster size&#xD;
        will consist of 470 patients with DM, determined as constant by how many patients with DM are&#xD;
        eligible for annual review. 348 GP practices would provide 80% power at the 5% significance&#xD;
        level to detect an increase in rate of CKD from 3% in the control arm to 4.3% in the&#xD;
        intervention arm. This would provide over 90% power at the 5% significance level to detect an&#xD;
        absolute increase of 7% in ACR test rate in the intervention arm compared to control (65% to&#xD;
        72%). The calculations assumed an ICC of 0.05, a coefficient of variation to allow for&#xD;
        variation in in cluster size of 0.128 (cluster size range of 360-600).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 18, 2022</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of patients with a diagnosis of CKD</measure>
      <time_frame>At 6 months follow up extraction</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of patients with ACR test in the last 12 months</measure>
      <time_frame>At 6 months follow up extraction (12 months preceding)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with newly diagnosed CKD (i.e., since randomisation)</measure>
      <time_frame>Between baseline and 6 months data extraction</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with albuminuria</measure>
      <time_frame>At 6 months follow up extraction</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with newly diagnosed albuminuria (i.e., since randomisation)</measure>
      <time_frame>Between baseline and 6 months data extraction</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">163560</enrollment>
    <condition>Diabetes</condition>
    <condition>Chronic Kidney Diseases</condition>
    <arm_group>
      <arm_group_label>Intervention:</arm_group_label>
      <description>Offered the Minuteful Kidney Test Kit</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <description>Continue as standard of care</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Minuteful Kidney Test Kit</intervention_name>
      <description>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</description>
      <arm_group_label>Intervention:</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The trial population are GP registered patients with a diabetes diagnosis in GP records&#xD;
          where the GP practice delivers routine annual screening for CKD via an ACR test based on an&#xD;
          anniversary date and follows-up patients with increased albuminuria to confirm a diagnosis&#xD;
          of CKD. Eligible GP practices will be recruited to participate in the trial.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          GP Practice Eligibility Criteria:&#xD;
  &#xD;
          Inclusion Criteria&#xD;
  &#xD;
            1. Included in the roll out at the time of the trial&#xD;
  &#xD;
            2. Willing and able to participate&#xD;
  &#xD;
            3. Willing to be randomised to either intervention or usual care&#xD;
  &#xD;
            4. Willing to provide the necessary trial data extractions and allow the research team&#xD;
               access to staff for qualitative elements of the research Exclusion Criteria&#xD;
  &#xD;
            5. Previous involvement with rollout of the Minuteful Kidney Test Kit&#xD;
  &#xD;
          Participant Eligibility Criteria:&#xD;
  &#xD;
          Inclusion Criteria&#xD;
  &#xD;
            1. Age &gt; 18&#xD;
  &#xD;
            2. Registered with a GP practice involved in the rollout during the time of the&#xD;
               evaluation.&#xD;
  &#xD;
            3. Diagnosed with diabetes (Type I / II) Exclusion Criteria&#xD;
  &#xD;
            4. National Data Opt-out of sharing for anything other than clinical care&#xD;
  &#xD;
          Eligibility Criteria to be offered the Minuteful Kidney Test Kit (for individuals in&#xD;
          practices randomised to intervention only)&#xD;
  &#xD;
          In intervention practices only individuals who satisfy all the criteria will be offered the&#xD;
          Minuteful Kidney Test Kit:&#xD;
  &#xD;
          Inclusion Criteria&#xD;
  &#xD;
            1. Age &gt; 18 years&#xD;
  &#xD;
            2. Registered with a GP practice involved in the rollout during the time of the&#xD;
               evaluation&#xD;
  &#xD;
            3. Diagnosed with diabetes (Type I / II)&#xD;
  &#xD;
            4. Those non-compliant with standard ACR screening practices and eligible for annual&#xD;
               tests&#xD;
  &#xD;
            5. Willing to perform a urine test at home&#xD;
  &#xD;
            6. Access to a smart phone&#xD;
  &#xD;
            7. An ability to understand written English Exclusion Criteria&#xD;
  &#xD;
            8. Pregnancy&#xD;
  &#xD;
            9. Care home residents&#xD;
  &#xD;
           10. Patients who are catheterised&#xD;
  &#xD;
           11. Patients who are on the end-of-life care pathway&#xD;
  &#xD;
          Additional Qualitative Process Evaluation Eligibility Criteria (for individuals in&#xD;
          practices randomised to intervention only) :&#xD;
  &#xD;
          Inclusion Criteria&#xD;
  &#xD;
            1. Willing and able to provide informed consent&#xD;
  &#xD;
            2. At home Minuteful Kidney Test received&#xD;
  &#xD;
            3. Willing and able to provide verbal consent for interview&#xD;
  &#xD;
            4. An ability to understand verbal and written English or access to language support&#xD;
               through family and/or friends&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Mid and South Essex (ICB)</name>
        <address>
          <city>Essex</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Leicester, Leicestershire and Rutland (ICB)</name>
        <address>
          <city>Leicester</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>North East London (ICB)</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>South East London (ICB)</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>North East and North Cumbria (NENC) - ICB</name>
        <address>
          <city>Newcastle</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Somerset (ICB)</name>
        <address>
          <city>Somerset</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>January 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Diabetes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05967312
  org study id: 0849
  secondary id: AI_AWARD01813
  secondary id: 304493
  nct id: NCT05967312
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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 being more common in those with diabetes. NICE CG182 and NICE QS05 define testing
        Albumin:Creatinine ratio (ACR) in at risk populations as critical from a clinical and cost
        point of view. Despite its importance in the prevention of kidney disease, ACR testing is the
        worst performing of all 9 NICE diabetes care processes with low screening rates among
        patients, making this a critical area for improvement. Home testing strategies may therefore
        be useful in improving proteinuria screening adherence, which the National CKD Audit (2017)
        (1) finding that up to 65% of people with diabetes have relevant annual urinary ACR tests.
  
        The overarching aim of The Minuteful Kidney Test Evaluation
  
          -  https://healthy.io/services/kidney
  
          -  https://www.nhsx.nhs.uk/ai-lab/explore-all-resources/understand-ai/healthyio-smartphone-
             albuminuria-urine-self-testing/ is to increase the use of ACR testing to identify
             previously undiagnosed albuminuria in those with diabetes. The primary hypothesis is
             that there will be an increase in proportion of individuals screened in general
             practices utilising the Minuteful Kidney Test (plus usual care) compared with general
             practices delivering usual care alone; and that this will result in a higher proportion
             of previously undiagnosed CKD being diagnosed in individuals in the intervention
             practices. The suitability of the technology for widescale deployment will also be
             addressed by exploring differences in outcomes by baseline characteristics alongside the
             qualitative process evaluation which will also gain an understanding of the technology's
             application across the UK population through a mixed method evaluation.
  
        Using a Cluster RCT design, randomisation will operate on a 1:1 basis with a 50% chance of a
        cluster being allocated to the intervention. 348 practices (clusters) are required, with one
        cluster added to each arm to account for any whole cluster drop out. The average cluster size
        will consist of 470 patients with DM, determined as constant by how many patients with DM are
        eligible for annual review. 348 GP practices would provide 80% power at the 5% significance
        level to detect an increase in rate of CKD from 3% in the control arm to 4.3% in the
        intervention arm. This would provide over 90% power at the 5% significance level to detect an
        absolute increase of 7% in ACR test rate in the intervention arm compared to control (65% to
        72%). The calculations assumed an ICC of 0.05, a coefficient of variation to allow for
        variation in in cluster size of 0.128 (cluster size range of 360-600).
  observational model: Case-Control
  time perspective: Prospective
  measure: Proportion of patients with a diagnosis of CKD
  time frame: At 6 months follow up extraction
  measure: Proportion of patients with ACR test in the last 12 months
  time frame: At 6 months follow up extraction (12 months preceding)
  measure: Proportion of patients with newly diagnosed CKD (i.e., since randomisation)
  time frame: Between baseline and 6 months data extraction
  measure: Proportion of patients with albuminuria
  time frame: At 6 months follow up extraction
  measure: Proportion of patients with newly diagnosed albuminuria (i.e., since randomisation)
  time frame: Between baseline and 6 months data extraction
  arm group label: Intervention:
  description: Offered the Minuteful Kidney Test Kit
  arm group label: Control
  description: Continue as standard of care
  intervention type: Diagnostic Test
  intervention name: Minuteful Kidney Test Kit
  description: 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
  arm group label: Intervention:
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic