<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/NCT03274063</url>
  </required_header>
  <id_info>
    <org_study_id>GoutSMART_NHSL_2YCR</org_study_id>
    <nct_id>NCT03274063</nct_id>
  </id_info>
  <brief_title>Gout Self-Monitoring Aiming to Reach Target</brief_title>
  <acronym>Gout-SMART</acronym>
  <official_title>Gout Self-Monitoring Aiming to Reach Target Serum Urate (Gout-SMART): Feasibility Study of Supported Self-management of Gout in Secondary Care Patients Requiring Escalation of Urate Lowering Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Edinburgh</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>
      This study evaluates whether a supported self-management approach to gout is able to achieve&#xD;
      target levels of serum urate, and better control of gout flares.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gout is the most common cause of inflammatory arthritis with recurrent gout flares a cause of&#xD;
      reduced quality of life, work absence and disability. Effective treatments are widely&#xD;
      available and yet many patients never achieve control of their disease. Resolution of gout&#xD;
      attacks requires sustained lowering of the levels of serum urate, which in practise is seldom&#xD;
      achieved. A supported self-management approach to gout has been developed which incorporates&#xD;
      self-testing of urate levels and a smartphone application that will prompt participants to&#xD;
      self-test and allow clinical researchers to titrate urate lowering therapies.&#xD;
&#xD;
      The feasibility of this approach will be evaluated in patients with gout referred to&#xD;
      secondary care. Participants will be randomised 2:1 to the intervention or a control group.&#xD;
      The intervention group will be offered supported self-management incorporating self-testing&#xD;
      of serum urate. The control group will receive usual care from their primary care physician.&#xD;
      The primary outcome will be the proportion of patients achieving levels of serum urate at or&#xD;
      below 0.3mmol/l by 6 months. Participants will be followed up for a total of 12 months to&#xD;
      assess the broader health and economic impact of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 5, 2019</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Laboratory staff measuring biochemical traits will be blind to treatment allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants achieving target urate levels (24 weeks)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Proportion of participants achieving serum urate level at, or below, 0.3mmol/l</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants achieving target urate levels (52 weeks)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Proportion of participants achieving serum urate level at, or below, 0.3mmol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flare frequency</measure>
    <time_frame>52 weeks</time_frame>
    <description>Prospectively gathered number of days of self-reported gout flares</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of tophi</measure>
    <time_frame>52 weeks</time_frame>
    <description>The size in mm of the largest tophus at baseline (index tophus) will be measured at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of tophi</measure>
    <time_frame>52 weeks</time_frame>
    <description>The number of clinically evident tophi will be evaluated at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported quality of life using EQ-5D-5L</measure>
    <time_frame>52 weeks</time_frame>
    <description>Prospectively gathered self-reported quality of life during/following gout flare evaluated using the EQ-5D-5L questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work absences</measure>
    <time_frame>52 weeks</time_frame>
    <description>Prospectively gathered data on days lost at work due to gout flare</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilisation</measure>
    <time_frame>52 weeks</time_frame>
    <description>Prospectively gathered number of scheduled and unscheduled medical appointments/ hospital admissions due to gout</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported medication compliance (24 weeks)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 24 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported medication compliance (52 weeks)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication compliance (24 weeks)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Plasma oxypurinol levels will be measured at 24 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication compliance (52 weeks)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Plasma oxypurinol levels will be measured at 52 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Gout</condition>
  <arm_group>
    <arm_group_label>Supported self-management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supported self-management</intervention_name>
    <description>Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .</description>
    <arm_group_label>Supported self-management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of gout (as per American College of Rheumatology criteria)&#xD;
&#xD;
          -  Physician recommendation that escalation of urate lowering therapy with allopurinol or&#xD;
             febuxostat is appropriate.&#xD;
&#xD;
          -  Serum urate &gt;0.36mm/L.&#xD;
&#xD;
          -  Patient has a mobile phone and is able to install GoutSMART application.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is unable to provide consent&#xD;
&#xD;
          -  Severe renal failure (eGFR &lt;30) or established liver disease&#xD;
&#xD;
          -  Previous adverse reaction to allopurinol or febuxostat&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip L Riches, FRCP PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Edinburgh/NHS Lothian</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Edinburgh</investigator_affiliation>
    <investigator_full_name>Philip Riches</investigator_full_name>
    <investigator_title>Consultant Rheumatologist &amp; Honorary Senior Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gout</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available on request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of study completion.</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a data access agreement.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>May 8, 2022</submitted>
    <returned>February 8, 2023</returned>
    <submitted>February 17, 2023</submitted>
    <returned>March 15, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03274063
org study id: GoutSMART_NHSL_2YCR
nct id: NCT03274063
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates whether a supported self-management approach to gout is able to achieve
      target levels of serum urate, and better control of gout flares.
Gout is the most common cause of inflammatory arthritis with recurrent gout flares a cause of
      reduced quality of life, work absence and disability. Effective treatments are widely
      available and yet many patients never achieve control of their disease. Resolution of gout
      attacks requires sustained lowering of the levels of serum urate, which in practise is seldom
      achieved. A supported self-management approach to gout has been developed which incorporates
      self-testing of urate levels and a smartphone application that will prompt participants to
      self-test and allow clinical researchers to titrate urate lowering therapies.

      The feasibility of this approach will be evaluated in patients with gout referred to
      secondary care. Participants will be randomised 2:1 to the intervention or a control group.
      The intervention group will be offered supported self-management incorporating self-testing
      of serum urate. The control group will receive usual care from their primary care physician.
      The primary outcome will be the proportion of patients achieving levels of serum urate at or
      below 0.3mmol/l by 6 months. Participants will be followed up for a total of 12 months to
      assess the broader health and economic impact of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Laboratory staff measuring biochemical traits will be blind to treatment allocation.
measure: Proportion of participants achieving target urate levels (24 weeks)
time frame: 24 weeks
description: Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
measure: Proportion of participants achieving target urate levels (52 weeks)
time frame: 52 weeks
description: Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
measure: Flare frequency
time frame: 52 weeks
description: Prospectively gathered number of days of self-reported gout flares
measure: Size of tophi
time frame: 52 weeks
description: The size in mm of the largest tophus at baseline (index tophus) will be measured at 52 weeks
measure: Presence of tophi
time frame: 52 weeks
description: The number of clinically evident tophi will be evaluated at 52 weeks
measure: Patient reported quality of life using EQ-5D-5L
time frame: 52 weeks
description: Prospectively gathered self-reported quality of life during/following gout flare evaluated using the EQ-5D-5L questionnaire.
measure: Work absences
time frame: 52 weeks
description: Prospectively gathered data on days lost at work due to gout flare
measure: Healthcare utilisation
time frame: 52 weeks
description: Prospectively gathered number of scheduled and unscheduled medical appointments/ hospital admissions due to gout
measure: Self-reported medication compliance (24 weeks)
time frame: 24 weeks
description: Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 24 weeks.
measure: Self-reported medication compliance (52 weeks)
time frame: 52 weeks
description: Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 52 weeks
measure: Medication compliance (24 weeks)
time frame: 24 weeks
description: Plasma oxypurinol levels will be measured at 24 weeks.
measure: Medication compliance (52 weeks)
time frame: 52 weeks
description: Plasma oxypurinol levels will be measured at 52 weeks.
arm group label: Supported self-management
arm group type: Active Comparator
description: Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing
arm group label: Usual care
arm group type: Sham Comparator
description: Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.
intervention type: Other
intervention name: Supported self-management
description: Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
arm group label: Supported self-management
intervention type: Other
intervention name: Usual care
description: Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philip L Riches, FRCP PhD
role: Principal Investigator
affiliation: University of Edinburgh/NHS Lothian
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Edinburgh
investigator full name: Philip Riches
investigator title: Consultant Rheumatologist & Honorary Senior Lecturer
mesh term: Gout
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available on request.
ipd info type: Study Protocol
ipd time frame: Data will be available within 6 months of study completion.
ipd access criteria: Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a data access agreement.
submitted: May 8, 2022
returned: February 8, 2023
submitted: February 17, 2023
returned: March 15, 2023