<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/NCT03816111</url>
  </required_header>
  <id_info>
    <org_study_id>AKTN 17.03</org_study_id>
    <nct_id>NCT03816111</nct_id>
  </id_info>
  <brief_title>Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes Trial</brief_title>
  <acronym>TEACH-PD</acronym>
  <official_title>A Pragmatic, Registry-based, International, Cluster-randomized Controlled Trial Examining the Use of TEACH-PD Training Modules for Incident PD Patients Versus Existing Practices on the Rate of PD-related Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Queensland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The HOME Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Australia and New Zealand Dialysis and Transplant Registry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New Zealand Peritoneal Dialysis Registry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Queensland</source>
  <oversight_info>
    <has_dmc>Yes</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>
      For many patients peritoneal dialysis (PD) is the preferred form of dialysis to treat kidney&#xD;
      disease as it provides greater flexibility and the ability to dialyse at home. However, PD&#xD;
      use in Australia has been decreasing over the last 10 years. A big reason for this drop is&#xD;
      the risk of infection. The best way to prevent PD related infections is to make sure that&#xD;
      patients have good training in PD techniques. The researchers of this study have developed&#xD;
      TEACH-PD, a new education package for training both PD nurses and PD patients.&#xD;
&#xD;
      The aim of this study is to find out whether TEACH-PD training reduces the number of PD&#xD;
      related infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      End stage kidney disease is fatal unless treated with dialysis or transplant. Peritoneal&#xD;
      dialysis (PD) is a core dialysis modality offering home-based care for patients. PD&#xD;
      utilization is frequently threatened beyond 5 years for most patients due to PD-related&#xD;
      infections. Patient training is a critical cornerstone of mitigating infection risk and&#xD;
      maximizing PD durability (technique survival), but training practices are characterized by a&#xD;
      lack of standardization and severe heterogeneity.&#xD;
&#xD;
      There is no high-level evidence to inform PD training. Accordingly, a structured program&#xD;
      encompassing how and what to teach PD patients at the inception of PD treatment has the&#xD;
      potential to reduce serious PD-related infections, extend the longevity of PD, support&#xD;
      cost-effective home-based dialysis care, and reduce costs and health service utilization&#xD;
      associated with hospitalization and transition to haemodialysis. TEACH-PD is a standardised&#xD;
      modular curriculum for both PD nurse trainers and patients that has been collaboratively&#xD;
      developed by renal nurses, doctors, educationalists and patients, aligned to current&#xD;
      International Society for Peritoneal Dialysis (ISPD) guidelines, utilizing modern adult&#xD;
      learning principles. The TEACH-PD program is feasible and acceptable, as demonstrated in a&#xD;
      successful pilot study.&#xD;
&#xD;
      The primary objective of TEACH-PD CRCT (Targeted Education ApproaCH to improve Peritoneal&#xD;
      Dialysis outcomes - a Cluster Randomised Controlled Trial) is to determine whether&#xD;
      implementation of standardised training modules based on ISPD guidelines targeting both PD&#xD;
      trainers and patients results in a longer time to the composite end-point of exit site&#xD;
      infections, tunnel infections and peritonitis in incident PD patients compared to existing&#xD;
      training practices.&#xD;
&#xD;
      TEACH-PD is a registry-based, pragmatic, multi-center, multinational trial, randomising PD&#xD;
      units to implementing TEACH-PD training modules targeted at PD trainers and incident PD&#xD;
      patients versus standard existing practices.&#xD;
&#xD;
      An estimated 1,500 patient new to PD will be recruited from at least approximately 42-44 PD&#xD;
      units in Australia and New Zealand.The study is being coordinated by the University of&#xD;
      Queensland (operating through the Australasian Kidney Trial Network).&#xD;
&#xD;
      The TEACH-PD training modules have been developed by a core group of renal nurses from the&#xD;
      HOME Network in conjunction with senior medical clinicians from the Australasian Kidney&#xD;
      Trials Network, eLearning curriculum developers, consumer representatives, and education&#xD;
      experts, in line with the ISPD guidelines, utilizing modern adult learning principles and&#xD;
      best practice eLearning techniques. The modules will be implemented at PD units in Australia&#xD;
      and New Zealand to formally evaluate whether, compared with standard care, a standardised&#xD;
      training curriculum will reduce the rate of PD-related infections and improve technique&#xD;
      survival, resulting in better outcomes for patients receiving PD and significant cost-savings&#xD;
      to the community.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 22, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 30, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to the first occurrence of any PD-related infection</measure>
    <time_frame>From the PD start date until first PD-related infection, assessed up to 4 years</time_frame>
    <description>Time to the first occurrence of any PD-related infection including exit site infection, tunnel infection or peritonitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first exit site infection</measure>
    <time_frame>From the PD start date until first exit site infection, assessed up to 4 years</time_frame>
    <description>Time to first exit site infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first tunnel infection</measure>
    <time_frame>From the PD start date until first tunnel infection, assessed up to 4 years</time_frame>
    <description>Time to first tunnel infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first episode of peritonitis</measure>
    <time_frame>From the PD start date until first peritonitis episode, assessed up to 4 years</time_frame>
    <description>Time to first episode of peritonitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to infection-associated catheter removal</measure>
    <time_frame>From the PD start date until first infection-associated catheter removal, assessed up to 4 years</time_frame>
    <description>Time to infection-associated catheter removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of technique failure - 30 days</measure>
    <time_frame>Assessed at 30 days after transfer to HD or if death occurs within this period</time_frame>
    <description>Incidence of technique failure defined as transfer to haemodialysis for greater than 30-days and/or death within this time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of technique failure - 180 days</measure>
    <time_frame>Assessed at 180 days after transfer to HD or if death occurs within this period</time_frame>
    <description>Incidence of technique failure defined as transfer to haemodialysis for greater than 180-days and/or death within this time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of all-cause hospitalization</measure>
    <time_frame>Assessed from the PD start date, over up to 4 years</time_frame>
    <description>Incidence of all-cause hospitalization collected via health department hospitalization data linkage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of all-cause mortality</measure>
    <time_frame>Assessed from the PD start date, over up to 4 years</time_frame>
    <description>Incidence of all-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Quality of Life questionnaire</measure>
    <time_frame>Completed at baseline, 6, 12, 18 and 24 months</time_frame>
    <description>Participant-reported Quality of Life measured using EQ-5D-5L (EuroQol-5 dimensions questionnaire). EQ-5D-5L measures quality of life using 2 methods - a descriptive scale and a Visual Analogue Scale. The descriptive scale comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/ depression). Each dimension has 5 measurement levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Numbers associated with levels can be used to report an index score.&#xD;
The VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-care cost-effectiveness analysis</measure>
    <time_frame>Assessed from the PD start date, over up to 4 years</time_frame>
    <description>Difference in the incremental cost per Quality Adjusted Life Years gained between treatment arms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Life participation questionnaire</measure>
    <time_frame>Completed at baseline and 24 months</time_frame>
    <description>Life participation measured using PROMIS (patient-reported outcomes measurement information system) Short Form - Ability to participate in social roles and activities 6a. PROMIS will measure 6 dimensions (trouble with leisure activities, trouble doing family activities, trouble doing work, trouble doing activities with friends, limiting fun with others and limiting activities with friends). Each dimension has 5 measurement levels: Always (1), Usually, (2), Sometimes (3), Rarely (4) and Never (5).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Kidney Disease, Chronic</condition>
  <condition>Peritoneal Dialysis Catheter-Associated Peritonitis</condition>
  <condition>Peritoneal Dialysis Catheter Exit Site Infection</condition>
  <condition>Peritoneal Dialysis Catheter Tunnel Infection</condition>
  <arm_group>
    <arm_group_label>TEACH-PD Training Curriculum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients at sites randomized to this arm will receive the TEACH-PD Training Curriculum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Current Standard PD Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients at sites randomized to this arm will receive the unit's current PD training materials and plan</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TEACH-PD Training Curriculum</intervention_name>
    <description>The TEACH-PD training modules have been developed by a core group of renal nurses from the HOME Network in conjunction with senior medical clinicians from the Australasian Kidney Trials Network, eLearning curriculum developers, consumer representatives, and education experts, in line with the International Society for Peritoneal Dialysis guidelines, utilizing modern adult learning principles and best practice eLearning techniques.</description>
    <arm_group_label>TEACH-PD Training Curriculum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Current standard PD training</intervention_name>
    <description>Current PD training materials and plan</description>
    <arm_group_label>Current Standard PD Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients new to PD;&#xD;
&#xD;
          -  Patients &gt; 18 years of age,&#xD;
&#xD;
          -  Need to undergo PD training;&#xD;
&#xD;
          -  Are able to provide informed consent&#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>Neil C Boudville, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>University of Western Australia &amp; Sir Charles Gairdner Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Josephine S Chow, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>South Western Sydney Local Health District</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yeoungjee Cho, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Queensland Health/Princess Alexandra Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yeoungjee Cho, PhD</last_name>
    <phone>+61 7 3176 2732</phone>
    <email>Yeoungjee.Cho@health.qld.gov.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laura Robison, BSc</last_name>
    <phone>+61 427911414</phone>
    <email>teachpd@uq.edu.au</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Canberra Hospital</name>
      <address>
        <city>Canberra</city>
        <state>Australian Capital Territory</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard Singer</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monica Bexton</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gosford Hospital</name>
      <address>
        <city>Gosford</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanne Kemp</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lismore Hospital</name>
      <address>
        <city>Lismore</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sanjeev Baweja, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orange Hospital</name>
      <address>
        <city>Orange</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathryn Anderson</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruce Cooper</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tim Spicer</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nepean/Blacktown Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kamal Sud</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michaela Kelleher</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred/Concord Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Saunders</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St George Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Cuesta</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tamworth Hospital</name>
      <address>
        <city>Tamworth</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen May</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Tweed Hospital</name>
      <address>
        <city>Tweed Heads</city>
        <state>New South Wales</state>
        <zip>2485</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Gosling</last_name>
      <phone>07 5506 7200</phone>
      <email>Andrew.gosling@health.nsw.gov.au</email>
    </contact>
    <investigator>
      <last_name>Andrew Gosling</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Darwin Hospital</name>
      <address>
        <city>Darwin</city>
        <state>Northern Territory</state>
        <zip>0810</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bidhun Paulose, MD</last_name>
      <phone>+61(0)889228888</phone>
      <email>Bidhun.Paulose@nt.gov.au</email>
    </contact>
    <contact_backup>
      <last_name>Nadine Tinsley, RN</last_name>
      <phone>+61 8 89226485</phone>
      <email>PeritonealDialysisCas.THS@nt.gov.au</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Johnson</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cairns Hospital</name>
      <address>
        <city>Cairns</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harris Hakim</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Wolley</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mackay Base Hospital</name>
      <address>
        <city>Mackay</city>
        <state>Queensland</state>
        <zip>4740</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roy Cherian</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Logan Hospital</name>
      <address>
        <city>Meadowbrook</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ken Tan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast University Hospital</name>
      <address>
        <city>Nambour</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Nataatmadja</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Murthy Divi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Toowoomba Hospital</name>
      <address>
        <city>Toowoomba</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alok Gupta</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen McDonald</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Hobart Hospital</name>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <zip>7000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Jose</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Launceston General Hospital</name>
      <address>
        <city>Launceston</city>
        <state>Tasmania</state>
        <zip>7250</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathew Mathew</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Monash Health</name>
      <address>
        <city>Dandenong</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fiona Brown</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frank Ierino</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Barwon Health</name>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Somerville</last_name>
    </contact>
    <contact_backup>
      <last_name>Rosie Simmonds</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Austin Health</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matt Davies</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanne Moody</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital</name>
      <address>
        <city>Murdoch</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ramyasuda Swaminathan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neil Boudville</last_name>
      <email>neil.boudville@uwa.edu.au</email>
    </contact>
    <investigator>
      <last_name>Neil Boudville</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Greg Perry, Dr</last_name>
      <email>gregory.perry@health.wa.gov.au</email>
    </contact>
    <investigator>
      <last_name>Greg Perry, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Waitakere Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>0610</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emad Maher</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>North Shore Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>0620</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emad Maher</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Auckland Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thu Nguyen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Middlemore Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jamie Kendrick-Jones</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wairau Hospital</name>
      <address>
        <city>Blenheim</city>
        <zip>7201</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline Chembo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Penny Hill</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dunedin Hospital</name>
      <address>
        <city>Dunedin</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tracey Putt</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gisborne Hospital</name>
      <address>
        <city>Gisborne</city>
        <zip>4010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eddie Tan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Waikato Hospital</name>
      <address>
        <city>Hamilton</city>
        <zip>3204</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eddie Tan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hawke's Bay Hospital</name>
      <address>
        <city>Hastings</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annie Reynolds</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nelson Hospital</name>
      <address>
        <city>Nelson</city>
        <zip>7010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline Chembo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taranaki Hospital</name>
      <address>
        <city>New Plymouth</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashik Hayat</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Palmerston North/Whanganui Hospital</name>
      <address>
        <city>Palmerston North</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marilyn Aday</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Wellington</city>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline Chembo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Whangarei Hospital</name>
      <address>
        <city>Whangarei</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Walaa Saweirs</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>August 3, 2022</last_update_submitted>
  <last_update_submitted_qc>August 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Peritonitis</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in the investigator's University's data warehouse but without investigator support other than deposited metadata.</ipd_time_frame>
    <ipd_access_criteria>An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.</ipd_access_criteria>
  </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/NCT03816111
org study id: AKTN 17.03
nct id: NCT03816111
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
For many patients peritoneal dialysis (PD) is the preferred form of dialysis to treat kidney
      disease as it provides greater flexibility and the ability to dialyse at home. However, PD
      use in Australia has been decreasing over the last 10 years. A big reason for this drop is
      the risk of infection. The best way to prevent PD related infections is to make sure that
      patients have good training in PD techniques. The researchers of this study have developed
      TEACH-PD, a new education package for training both PD nurses and PD patients.

      The aim of this study is to find out whether TEACH-PD training reduces the number of PD
      related infections.
End stage kidney disease is fatal unless treated with dialysis or transplant. Peritoneal
      dialysis (PD) is a core dialysis modality offering home-based care for patients. PD
      utilization is frequently threatened beyond 5 years for most patients due to PD-related
      infections. Patient training is a critical cornerstone of mitigating infection risk and
      maximizing PD durability (technique survival), but training practices are characterized by a
      lack of standardization and severe heterogeneity.

      There is no high-level evidence to inform PD training. Accordingly, a structured program
      encompassing how and what to teach PD patients at the inception of PD treatment has the
      potential to reduce serious PD-related infections, extend the longevity of PD, support
      cost-effective home-based dialysis care, and reduce costs and health service utilization
      associated with hospitalization and transition to haemodialysis. TEACH-PD is a standardised
      modular curriculum for both PD nurse trainers and patients that has been collaboratively
      developed by renal nurses, doctors, educationalists and patients, aligned to current
      International Society for Peritoneal Dialysis (ISPD) guidelines, utilizing modern adult
      learning principles. The TEACH-PD program is feasible and acceptable, as demonstrated in a
      successful pilot study.

      The primary objective of TEACH-PD CRCT (Targeted Education ApproaCH to improve Peritoneal
      Dialysis outcomes - a Cluster Randomised Controlled Trial) is to determine whether
      implementation of standardised training modules based on ISPD guidelines targeting both PD
      trainers and patients results in a longer time to the composite end-point of exit site
      infections, tunnel infections and peritonitis in incident PD patients compared to existing
      training practices.

      TEACH-PD is a registry-based, pragmatic, multi-center, multinational trial, randomising PD
      units to implementing TEACH-PD training modules targeted at PD trainers and incident PD
      patients versus standard existing practices.

      An estimated 1,500 patient new to PD will be recruited from at least approximately 42-44 PD
      units in Australia and New Zealand.The study is being coordinated by the University of
      Queensland (operating through the Australasian Kidney Trial Network).

      The TEACH-PD training modules have been developed by a core group of renal nurses from the
      HOME Network in conjunction with senior medical clinicians from the Australasian Kidney
      Trials Network, eLearning curriculum developers, consumer representatives, and education
      experts, in line with the ISPD guidelines, utilizing modern adult learning principles and
      best practice eLearning techniques. The modules will be implemented at PD units in Australia
      and New Zealand to formally evaluate whether, compared with standard care, a standardised
      training curriculum will reduce the rate of PD-related infections and improve technique
      survival, resulting in better outcomes for patients receiving PD and significant cost-savings
      to the community.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Time to the first occurrence of any PD-related infection
time frame: From the PD start date until first PD-related infection, assessed up to 4 years
description: Time to the first occurrence of any PD-related infection including exit site infection, tunnel infection or peritonitis
measure: Time to first exit site infection
time frame: From the PD start date until first exit site infection, assessed up to 4 years
description: Time to first exit site infection
measure: Time to first tunnel infection
time frame: From the PD start date until first tunnel infection, assessed up to 4 years
description: Time to first tunnel infection
measure: Time to first episode of peritonitis
time frame: From the PD start date until first peritonitis episode, assessed up to 4 years
description: Time to first episode of peritonitis
measure: Time to infection-associated catheter removal
time frame: From the PD start date until first infection-associated catheter removal, assessed up to 4 years
description: Time to infection-associated catheter removal
measure: Incidence of technique failure - 30 days
time frame: Assessed at 30 days after transfer to HD or if death occurs within this period
description: Incidence of technique failure defined as transfer to haemodialysis for greater than 30-days and/or death within this time
measure: Incidence of technique failure - 180 days
time frame: Assessed at 180 days after transfer to HD or if death occurs within this period
description: Incidence of technique failure defined as transfer to haemodialysis for greater than 180-days and/or death within this time
measure: Incidence of all-cause hospitalization
time frame: Assessed from the PD start date, over up to 4 years
description: Incidence of all-cause hospitalization collected via health department hospitalization data linkage
measure: Incidence of all-cause mortality
time frame: Assessed from the PD start date, over up to 4 years
description: Incidence of all-cause mortality
measure: Participant Quality of Life questionnaire
time frame: Completed at baseline, 6, 12, 18 and 24 months
description: Participant-reported Quality of Life measured using EQ-5D-5L (EuroQol-5 dimensions questionnaire). EQ-5D-5L measures quality of life using 2 methods - a descriptive scale and a Visual Analogue Scale. The descriptive scale comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/ depression). Each dimension has 5 measurement levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Numbers associated with levels can be used to report an index score.
The VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
measure: Health-care cost-effectiveness analysis
time frame: Assessed from the PD start date, over up to 4 years
description: Difference in the incremental cost per Quality Adjusted Life Years gained between treatment arms
measure: Life participation questionnaire
time frame: Completed at baseline and 24 months
description: Life participation measured using PROMIS (patient-reported outcomes measurement information system) Short Form - Ability to participate in social roles and activities 6a. PROMIS will measure 6 dimensions (trouble with leisure activities, trouble doing family activities, trouble doing work, trouble doing activities with friends, limiting fun with others and limiting activities with friends). Each dimension has 5 measurement levels: Always (1), Usually, (2), Sometimes (3), Rarely (4) and Never (5).
arm group label: TEACH-PD Training Curriculum
arm group type: Experimental
description: All patients at sites randomized to this arm will receive the TEACH-PD Training Curriculum
arm group label: Current Standard PD Training
arm group type: Active Comparator
description: All patients at sites randomized to this arm will receive the unit's current PD training materials and plan
intervention type: Behavioral
intervention name: TEACH-PD Training Curriculum
description: The TEACH-PD training modules have been developed by a core group of renal nurses from the HOME Network in conjunction with senior medical clinicians from the Australasian Kidney Trials Network, eLearning curriculum developers, consumer representatives, and education experts, in line with the International Society for Peritoneal Dialysis guidelines, utilizing modern adult learning principles and best practice eLearning techniques.
arm group label: TEACH-PD Training Curriculum
intervention type: Behavioral
intervention name: Current standard PD training
description: Current PD training materials and plan
arm group label: Current Standard PD Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neil C Boudville, Prof
role: Study Chair
affiliation: University of Western Australia & Sir Charles Gairdner Hospital
last name: Josephine S Chow, Prof
role: Study Chair
affiliation: South Western Sydney Local Health District
last name: Yeoungjee Cho, PhD
role: Study Director
affiliation: Queensland Health/Princess Alexandra Hospital
last name: Yeoungjee Cho, PhD
phone: +61 7 3176 2732
email: Yeoungjee.Cho@health.qld.gov.au
last name: Laura Robison, BSc
phone: +61 427911414
email: teachpd@uq.edu.au
facility: 
status: Recruiting
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country: Australia
country: New Zealand
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Peritonitis
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in the investigator's University's data warehouse but without investigator support other than deposited metadata.
ipd access criteria: An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.