<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/NCT03019159</url>
  </required_header>
  <id_info>
    <org_study_id>TLM-HSMDP</org_study_id>
    <nct_id>NCT03019159</nct_id>
  </id_info>
  <brief_title>Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis</brief_title>
  <acronym>HSMDP</acronym>
  <official_title>Efficacy and Cost-effectiveness Assessment of a Follow-up With Tele-consulting for Patients With Chronic Renal Failure Under Peritoneal Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agence Regionale de Sante d'Ile de France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to determine whether tele-consulting for the follow up of&#xD;
      patients with renal failure under peritoneal dialysis would not increase the risk of&#xD;
      experiencing a severe adverse event&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Support funding of the regional health authority stopped&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Severe adverse events</measure>
    <time_frame>Within 2 years after enrollment</time_frame>
    <description>Death, Peritonitis, acute pulmonary edema, symptomatic hyperkalemia or with EKG signs, severe and resistant hypertension, with uremia &gt; 40 mmol/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalisations</measure>
    <time_frame>Within 2 years after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of consultations</measure>
    <time_frame>Within 2 years after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sanitary transportation</measure>
    <time_frame>Within 2 years after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean length of hospital stay</measure>
    <time_frame>Within 2 years after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global costs</measure>
    <time_frame>6 months after the first patient enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients satisfaction</measure>
    <time_frame>1 year after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the professionnals</measure>
    <time_frame>6 months after enrollment of the first patient</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Renal Failure</condition>
  <condition>Peritoneal Dialysis</condition>
  <arm_group>
    <arm_group_label>Tele-consulting</arm_group_label>
    <description>One visit out of two takes place with teleconsulting and the other is a face-to-face consultation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No tele-consulting</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Teleconsulting</intervention_name>
    <arm_group_label>Tele-consulting</arm_group_label>
    <other_name>Telemedicine</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with renal failure under peritoneal dialysis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient under peritoneal dialysis for more than three month&#xD;
&#xD;
          -  Patient thought to be able to perform peritoneal dialysis alone or with the help of&#xD;
             health care professionnals&#xD;
&#xD;
          -  Patients or health care professionnals thought to be able to use telemedicine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No DSL Network&#xD;
&#xD;
          -  No GSM Network&#xD;
&#xD;
          -  Patients who can not express their opposition to the participation to this study&#xD;
             because of limited mental abilities&#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>Stéphane Roueff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pôle CTIRC. Hôpitaux Saint Maurice</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Isabelle Durand-Zaleski, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>DRCD URC Eco. Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CTIRC - Hôpitaux Saint Maurice</name>
      <address>
        <city>Saint Maurice</city>
        <zip>94410</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.renewinghealth.eu/assessment-method</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. doi: 10.1258/135763307781644906.</citation>
    <PMID>17785025</PMID>
  </reference>
  <reference>
    <citation>Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.</citation>
    <PMID>22617736</PMID>
  </reference>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT03019159
org study id: TLM-HSMDP
nct id: NCT03019159
lead sponsor: 
collaborator: 
has dmc: No
The objective of the study is to determine whether tele-consulting for the follow up of
      patients with renal failure under peritoneal dialysis would not increase the risk of
      experiencing a severe adverse event
observational model: Case-Control
time perspective: Prospective
measure: Severe adverse events
time frame: Within 2 years after enrollment
description: Death, Peritonitis, acute pulmonary edema, symptomatic hyperkalemia or with EKG signs, severe and resistant hypertension, with uremia > 40 mmol/L
measure: Number of hospitalisations
time frame: Within 2 years after enrollment
measure: Number of consultations
time frame: Within 2 years after enrollment
measure: Number of sanitary transportation
time frame: Within 2 years after enrollment
measure: Mean length of hospital stay
time frame: Within 2 years after enrollment
measure: Global costs
time frame: 6 months after the first patient enrollment
measure: Patients satisfaction
time frame: 1 year after enrollment
measure: Satisfaction of the professionnals
time frame: 6 months after enrollment of the first patient
arm group label: Tele-consulting
description: One visit out of two takes place with teleconsulting and the other is a face-to-face consultation
arm group label: No tele-consulting
intervention type: Device
intervention name: Teleconsulting
arm group label: Tele-consulting
other name: Telemedicine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stéphane Roueff, MD
role: Principal Investigator
affiliation: Pôle CTIRC. Hôpitaux Saint Maurice
last name: Isabelle Durand-Zaleski, MD, PhD
role: Principal Investigator
affiliation: DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
facility: 
country: France
url: http://www.renewinghealth.eu/assessment-method
description: Related Info
citation: Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. doi: 10.1258/135763307781644906.
PMID: 17785025
citation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
PMID: 22617736
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency, Chronic