<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/NCT03293147</url>
  </required_header>
  <id_info>
    <org_study_id>R120993</org_study_id>
    <nct_id>NCT03293147</nct_id>
  </id_info>
  <brief_title>OUTREACH: Urine Analysis and Antihypertensive Treatment</brief_title>
  <acronym>OUTREACH</acronym>
  <official_title>BiOmarkers in Urine, anTihypeRtensive trEAtment and Blood Pressure Control in Hypertensive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>British Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Manchester Academic Health Science Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Omron Healthcare Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manchester</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>
      Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood&#xD;
      pressure control and translates into increased risk of cardiovascular morbidity and&#xD;
      mortality. Currently, there is no effective intervention for therapeutic non-adherence. Our&#xD;
      project will assess whether high performance liquid chromatography mass spectrometry&#xD;
      (HPLC-MS/MS)-guided intervention (providing patients with information on the results of their&#xD;
      HPLC-MS/MS-based urine analysis combined with targeting the main reason for non-adherence)&#xD;
      leads to an improvement in blood pressure control, adherence and a reduction in healthcare&#xD;
      costs. Our multicentre prospective randomised controlled trial consists of 6 stages&#xD;
      (screening, recruitment, baseline phenotype assessment, intervention, short-term and&#xD;
      long-term outcome visits). The study will fill in an important gap in knowledge on management&#xD;
      of blood pressure in non-adherent hypertensive patients beyond the initial diagnostic step.&#xD;
      It will also inform the development of a cost-effective model for the management of&#xD;
      non-adherence in chronic disorders that require long-term drug therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood&#xD;
      pressure control and translates into increased risk of cardiovascular morbidity and&#xD;
      mortality. Currently, there is no effective intervention for therapeutic non-adherence.&#xD;
&#xD;
      An ultra-sensitive and highly specific biochemical assay has been developed to detect urinary&#xD;
      biomarkers of antihypertensive treatment. The high performance liquid chromatography mass&#xD;
      spectrometry (HPLC-MS/MS)-based assay screens spot urine samples for the presence of 40&#xD;
      commonly prescribed blood pressure lowering medications. The results of the test provide a&#xD;
      clinician with information on the presence/absence of prescribed antihypertensive drugs&#xD;
      or/and their metabolites in urine - a direct confirmation of therapeutic&#xD;
      adherence/non-adherence.&#xD;
&#xD;
      The study is a prospective multi-centre randomised controlled trial to examine if&#xD;
      HPLC-MS/MS-guided intervention is superior to standard clinical care in improving clinical,&#xD;
      behavioural and health-economy outcomes in hypertensive patients who are non-adherent to&#xD;
      antihypertensive treatment.&#xD;
&#xD;
      Patient adherence to antihypertensive treatment will be determined at baseline. Non-adherent&#xD;
      hypertensive patients at baseline will be randomised in a 1:1 ration to either usual clinical&#xD;
      care plus HPLC-MS/MS-guided intervention (Arm A) or usual clinical care only (Arm B).&#xD;
&#xD;
      The study also evaluates a cohort of patients who are adherent to antihypertensive treatment&#xD;
      at baseline. Those adherent hypertensive patients will receive the usual clinical care (Arm&#xD;
      C). The main purpose of involving this group of patients is to blind the clinical research&#xD;
      staff to the adherence status of those patients randomised receiving standard care alone, to&#xD;
      prevent introducing any bias in treating non-adherent patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 4, 2023</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>Multi-center randomised controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants and clinicians will initially be blinded to the result of the baseline (at trial entry) HPLC-MS/MS based urine test to determine the participant adherence to antihypertensive treatment.&#xD;
Non-adherent patients allocated to Arm A will be un-blinded at the stage of visit 3 where the results of their HPLC-MS/MS urine test will be revealed to them as a part of HPLC-MS/MS-guided intervention. The doctor will also require un-blinding to provide the required intervention. However, during further study visits the research personnel will remain blinded as to the adherence status of these patients, the results of their HPLC-MS/MS-based analysis and the treatment allocation. The doctor who delivers the intervention will not be involved in collecting clinical information necessary to define outcomes during appointments 4 and 5.&#xD;
Hypertensive patients randomised to Arms B and C will remain blinded to the results of their HPLC-MS/MS-based urine test throughout all stages of the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Clinic systolic blood pressure</measure>
    <time_frame>visit 4 (short term follow-up; 3 months post intervention)</time_frame>
    <description>Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in clinic systolic blood pressure</measure>
    <time_frame>visit 5 (long term follow-up; ~4.5 months post intervention)</time_frame>
    <description>Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinic diastolic blood pressure</measure>
    <time_frame>visit 4 (short term follow-up; ~3 months post intervention)</time_frame>
    <description>Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of diastolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinic diastolic blood pressure</measure>
    <time_frame>visit 5 (long term follow-up; ~4.5 months post intervention)</time_frame>
    <description>Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of diastolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in home blood pressure</measure>
    <time_frame>visit 4 (short term follow-up; ~3 months post intervention)</time_frame>
    <description>This measurement will be conducted using oscillometric Omron monitors. Patients will be handed the monitors by the research nurses at each visit and will be provided instructions to use the Omron monitor. While all blood pressure measurements will be stored automatically on the monitors, patients will be also asked to keep a written record on paper (to avoid loss of data in case a monitor stops working or goes out of order).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in home blood pressure</measure>
    <time_frame>visit 5 (long term follow-up; ~4.5 months post intervention)</time_frame>
    <description>This measurement will be conducted using oscillometric Omron monitors. Patients will be handed the monitors by the research nurses at each visit and will be provided instructions to use the Omron monitor. While all blood pressure measurements will be stored automatically on the monitors, patients will be also asked to keep a written record on paper (to avoid loss of data in case a monitor stops working or goes out of order).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biochemical adherence of patients</measure>
    <time_frame>visit 2 (~3 weeks post recruitment)</time_frame>
    <description>HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biochemical adherence of patients</measure>
    <time_frame>visit 4 (short term follow-up; ~3 months post intervention)</time_frame>
    <description>HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biochemical adherence of patients</measure>
    <time_frame>visit 5 (long term follow-up; ~4.5 months post intervention)</time_frame>
    <description>HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urinary albumin / creatinine ratio</measure>
    <time_frame>visit 4 (short term follow-up; ~3 months post intervention)</time_frame>
    <description>Urinary albumin / creatinine ratio is a urinary marker of target organ damage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urinary albumin / creatinine ratio</measure>
    <time_frame>visit 5 (long term follow-up; ~4.5 months post intervention)</time_frame>
    <description>Urinary albumin / creatinine ratio is a urinary marker of target organ damage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health economy parameters</measure>
    <time_frame>visit 4 (short term follow-up; ~3 months post intervention)</time_frame>
    <description>Health economy parameters (collected via questionnaires) will be calculated over the study time horizon to determine total costs of clinical/social care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health economy parameters</measure>
    <time_frame>visit 5 (long term follow-up; ~4.5 months post intervention)</time_frame>
    <description>Health economy parameters (collected via questionnaires) will be calculated over the study time horizon to determine total costs of clinical/social care</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in psychological profile</measure>
    <time_frame>visit 4 (short term follow-up; ~3 months post intervention)</time_frame>
    <description>Psychological questionnaires assessing participants perspectives of treatment will be completed by patient when attending clinic visit 1, 4 and 5</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in psychological profile</measure>
    <time_frame>visit 5 (long term follow-up; ~4.5 months post intervention)</time_frame>
    <description>Psychological questionnaires assessing participants perspectives of treatment will be completed by patient when attending clinic visit 1, 4 and 5</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Hypertension</condition>
  <condition>Adherence, Medication</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group: Non-adherent hypertensive patients randomised in Arm A will receive standard clinical care plus HPLC-MS/MS-guided intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group: Non-adherent hypertensive patients randomised in Arm B will receive clinical standard care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group: Adherent hypertensive patients randomised in Arm C will receive clinical standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HPLC-MS/MS-guided intervention</intervention_name>
    <description>The HPLC-MS/MS-guided intervention consists of providing partially or totally non-adherent hypertensive patients with information on the results of their HPLC-MS/MS-based urine analysis combined with tailored targeting of the main reason(s) for the deviation from the prescribed antihypertensive treatment</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>Standard care for hypertensive patients</description>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 18 years or above&#xD;
&#xD;
          -  Patients previously diagnosed with and pharmacologically managed for hypertension&#xD;
&#xD;
          -  Patients with antihypertensive treatment with at least two antihypertensive&#xD;
             medications&#xD;
&#xD;
          -  Patients have full capability of providing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with recent history of admission to the hospital relating to their&#xD;
             hypertension or treatment with anti-hypertensive medications (&lt;2 weeks) (i)&#xD;
&#xD;
          -  Patient refusal for 7-day home-based blood pressure monitoring (7-HBBPM)&#xD;
&#xD;
          -  Self-reported pregnancy or breastfeeding&#xD;
&#xD;
          -  Female patients planning to conceive within the next 6 months&#xD;
&#xD;
             (i) Including admission to A&amp;E&#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>Maciej Tomaszewski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marta Ahmed, MA</last_name>
    <phone>+44 (0)161 276 1227</phone>
    <phone_ext>51227</phone_ext>
    <email>OUTREACH1@manchester.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc George, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Manchester Royal Infirmary</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maciej Tomaszewski, MD</last_name>
    </contact>
    <investigator>
      <last_name>Maciej Tomaszewski, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital</name>
      <address>
        <city>Dundee</city>
        <state>Scotland</state>
        <zip>DD2 1SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas MacDonald, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Alvaston Medical Centre</name>
      <address>
        <city>Derby</city>
        <zip>DE24 0GE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anshuman Ghosh, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Epsom &amp; St. Helier University Hospitals NHS Trust</name>
      <address>
        <city>Epsom</city>
        <zip>KT17 1HB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pauline A Swift, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Glenfield General Hospital</name>
      <address>
        <city>Leicester</city>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pankaj Gupta, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen Walsh, MD</last_name>
    </contact>
    <investigator>
      <last_name>Stephen Walsh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philip Chowienczyk, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Homerton Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Louise Abrams, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St Bartholomews Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Collier, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chilwell Valley and Meadows Practice</name>
      <address>
        <city>Nottingham</city>
        <zip>NG9 6DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victoria Robinson, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospitals Dorset NHS Foundation Trust</name>
      <address>
        <city>Poole</city>
        <zip>BH15 2JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Jordan, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Maciej Tomaszewski</investigator_full_name>
    <investigator_title>Professor of Cardiovascular Medicine</investigator_title>
  </responsible_party>
  <keyword>Blood pressure</keyword>
  <keyword>Antihypertensive treatment</keyword>
  <keyword>Adherence</keyword>
  <keyword>Biomarker</keyword>
  <keyword>Urine</keyword>
  <keyword>HPLC-MS/MS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03293147
org study id: R120993
nct id: NCT03293147
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood
      pressure control and translates into increased risk of cardiovascular morbidity and
      mortality. Currently, there is no effective intervention for therapeutic non-adherence. Our
      project will assess whether high performance liquid chromatography mass spectrometry
      (HPLC-MS/MS)-guided intervention (providing patients with information on the results of their
      HPLC-MS/MS-based urine analysis combined with targeting the main reason for non-adherence)
      leads to an improvement in blood pressure control, adherence and a reduction in healthcare
      costs. Our multicentre prospective randomised controlled trial consists of 6 stages
      (screening, recruitment, baseline phenotype assessment, intervention, short-term and
      long-term outcome visits). The study will fill in an important gap in knowledge on management
      of blood pressure in non-adherent hypertensive patients beyond the initial diagnostic step.
      It will also inform the development of a cost-effective model for the management of
      non-adherence in chronic disorders that require long-term drug therapy.
Non-adherence to antihypertensive treatment is one of the leading causes of suboptimal blood
      pressure control and translates into increased risk of cardiovascular morbidity and
      mortality. Currently, there is no effective intervention for therapeutic non-adherence.

      An ultra-sensitive and highly specific biochemical assay has been developed to detect urinary
      biomarkers of antihypertensive treatment. The high performance liquid chromatography mass
      spectrometry (HPLC-MS/MS)-based assay screens spot urine samples for the presence of 40
      commonly prescribed blood pressure lowering medications. The results of the test provide a
      clinician with information on the presence/absence of prescribed antihypertensive drugs
      or/and their metabolites in urine - a direct confirmation of therapeutic
      adherence/non-adherence.

      The study is a prospective multi-centre randomised controlled trial to examine if
      HPLC-MS/MS-guided intervention is superior to standard clinical care in improving clinical,
      behavioural and health-economy outcomes in hypertensive patients who are non-adherent to
      antihypertensive treatment.

      Patient adherence to antihypertensive treatment will be determined at baseline. Non-adherent
      hypertensive patients at baseline will be randomised in a 1:1 ration to either usual clinical
      care plus HPLC-MS/MS-guided intervention (Arm A) or usual clinical care only (Arm B).

      The study also evaluates a cohort of patients who are adherent to antihypertensive treatment
      at baseline. Those adherent hypertensive patients will receive the usual clinical care (Arm
      C). The main purpose of involving this group of patients is to blind the clinical research
      staff to the adherence status of those patients randomised receiving standard care alone, to
      prevent introducing any bias in treating non-adherent patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multi-center randomised controlled trial
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Participants and clinicians will initially be blinded to the result of the baseline (at trial entry) HPLC-MS/MS based urine test to determine the participant adherence to antihypertensive treatment.
Non-adherent patients allocated to Arm A will be un-blinded at the stage of visit 3 where the results of their HPLC-MS/MS urine test will be revealed to them as a part of HPLC-MS/MS-guided intervention. The doctor will also require un-blinding to provide the required intervention. However, during further study visits the research personnel will remain blinded as to the adherence status of these patients, the results of their HPLC-MS/MS-based analysis and the treatment allocation. The doctor who delivers the intervention will not be involved in collecting clinical information necessary to define outcomes during appointments 4 and 5.
Hypertensive patients randomised to Arms B and C will remain blinded to the results of their HPLC-MS/MS-based urine test throughout all stages of the study.
measure: Change in Clinic systolic blood pressure
time frame: visit 4 (short term follow-up; 3 months post intervention)
description: Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
measure: Change in clinic systolic blood pressure
time frame: visit 5 (long term follow-up; ~4.5 months post intervention)
description: Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of systolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
measure: Change in clinic diastolic blood pressure
time frame: visit 4 (short term follow-up; ~3 months post intervention)
description: Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of diastolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
measure: Change in clinic diastolic blood pressure
time frame: visit 5 (long term follow-up; ~4.5 months post intervention)
description: Blood pressure measurements will be taken after 5 minutes of rest in a sitting position with an electronic digital Omron monitor and the cuff size adjusted to the arm circumference as per international guidelines. Three measurements of diastolic blood pressure will be taken in a row (separated by approximately 1 minute interval) and recorded at every visit
measure: Change in home blood pressure
time frame: visit 4 (short term follow-up; ~3 months post intervention)
description: This measurement will be conducted using oscillometric Omron monitors. Patients will be handed the monitors by the research nurses at each visit and will be provided instructions to use the Omron monitor. While all blood pressure measurements will be stored automatically on the monitors, patients will be also asked to keep a written record on paper (to avoid loss of data in case a monitor stops working or goes out of order).
measure: Change in home blood pressure
time frame: visit 5 (long term follow-up; ~4.5 months post intervention)
description: This measurement will be conducted using oscillometric Omron monitors. Patients will be handed the monitors by the research nurses at each visit and will be provided instructions to use the Omron monitor. While all blood pressure measurements will be stored automatically on the monitors, patients will be also asked to keep a written record on paper (to avoid loss of data in case a monitor stops working or goes out of order).
measure: Change in biochemical adherence of patients
time frame: visit 2 (~3 weeks post recruitment)
description: HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription
measure: Change in biochemical adherence of patients
time frame: visit 4 (short term follow-up; ~3 months post intervention)
description: HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription.
measure: Change in biochemical adherence of patients
time frame: visit 5 (long term follow-up; ~4.5 months post intervention)
description: HPLC-MS/MS test will determine the numbers and list of antihypertensive drugs detected in the patient urine sample and this will be compared to the patient prescription.
measure: Change in urinary albumin / creatinine ratio
time frame: visit 4 (short term follow-up; ~3 months post intervention)
description: Urinary albumin / creatinine ratio is a urinary marker of target organ damage.
measure: Change in urinary albumin / creatinine ratio
time frame: visit 5 (long term follow-up; ~4.5 months post intervention)
description: Urinary albumin / creatinine ratio is a urinary marker of target organ damage.
measure: Changes in health economy parameters
time frame: visit 4 (short term follow-up; ~3 months post intervention)
description: Health economy parameters (collected via questionnaires) will be calculated over the study time horizon to determine total costs of clinical/social care
measure: Changes in health economy parameters
time frame: visit 5 (long term follow-up; ~4.5 months post intervention)
description: Health economy parameters (collected via questionnaires) will be calculated over the study time horizon to determine total costs of clinical/social care
measure: Changes in psychological profile
time frame: visit 4 (short term follow-up; ~3 months post intervention)
description: Psychological questionnaires assessing participants perspectives of treatment will be completed by patient when attending clinic visit 1, 4 and 5
measure: Changes in psychological profile
time frame: visit 5 (long term follow-up; ~4.5 months post intervention)
description: Psychological questionnaires assessing participants perspectives of treatment will be completed by patient when attending clinic visit 1, 4 and 5
arm group label: Arm A
arm group type: Experimental
description: Intervention group: Non-adherent hypertensive patients randomised in Arm A will receive standard clinical care plus HPLC-MS/MS-guided intervention.
arm group label: Arm B
arm group type: Active Comparator
description: Control group: Non-adherent hypertensive patients randomised in Arm B will receive clinical standard care.
arm group label: Arm C
arm group type: Active Comparator
description: Control group: Adherent hypertensive patients randomised in Arm C will receive clinical standard care.
intervention type: Other
intervention name: HPLC-MS/MS-guided intervention
description: The HPLC-MS/MS-guided intervention consists of providing partially or totally non-adherent hypertensive patients with information on the results of their HPLC-MS/MS-based urine analysis combined with tailored targeting of the main reason(s) for the deviation from the prescribed antihypertensive treatment
arm group label: Arm A
intervention type: Other
intervention name: Standard care
description: Standard care for hypertensive patients
arm group label: Arm B
arm group label: Arm C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maciej Tomaszewski, MD
role: Principal Investigator
affiliation: University of Manchester
last name: Marta Ahmed, MA
phone: +44 (0)161 276 1227
phone ext: 51227
email: OUTREACH1@manchester.ac.uk
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status: Recruiting
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country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Maciej Tomaszewski
investigator title: Professor of Cardiovascular Medicine
mesh term: Hypertension
sharing ipd: No