<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/NCT02229279</url>
  </required_header>
  <id_info>
    <org_study_id>TLM-HAD</org_study_id>
    <nct_id>NCT02229279</nct_id>
  </id_info>
  <brief_title>Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures</brief_title>
  <acronym>SSRHAD</acronym>
  <official_title>Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures</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 this study is to assess the medical and economic relevance of teleconsulting&#xD;
      for Rehabilitation After Hip and Knee Surgical Procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2015</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional subscore of simplified WOMAC Scale</measure>
    <time_frame>up to 30 days after start of rehabilitation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Joint Paint measured with visual analogue scale</measure>
    <time_frame>up to 30 days after start of rehabilitation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction questionnaire</measure>
    <time_frame>The last 1 day of the rehabilitation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical and paramedical staff satisfaction questionnaire</measure>
    <time_frame>6 months after enrollment of the first patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall costs of treatment</measure>
    <time_frame>6 months after enrollment of the first patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalizations and use of emergency units</measure>
    <time_frame>Within 30 days after start of rehabilitation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">430</enrollment>
  <condition>Osteoarthritis, Hip</condition>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Teleconsulting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Teleconsulting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Teleconsulting</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Teleconsulting</intervention_name>
    <arm_group_label>Teleconsulting</arm_group_label>
    <other_name>Telemedicine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Post hip or knee surgery&#xD;
&#xD;
          -  Fulfilment of criteria for home rehabilitation (no need for hospital treatment post&#xD;
             surgery)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Social isolation&#xD;
&#xD;
          -  Life threatening condition&#xD;
&#xD;
          -  No GSM network&#xD;
&#xD;
          -  No DSL network&#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>Dominique Copin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Santé Service, Pôle Rééducation - Handicap</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>Fondation Santé Service, Pôle Rééducation- Handicap</name>
      <address>
        <city>Puteaux</city>
        <zip>92816</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>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>
  <reference>
    <citation>Tubach F, Baron G, Falissard B, Logeart I, Dougados M, Bellamy N, Ravaud P. Using patients' and rheumatologists' opinions to specify a short form of the WOMAC function subscale. Ann Rheum Dis. 2005 Jan;64(1):75-9. doi: 10.1136/ard.2003.019539.</citation>
    <PMID>15608303</PMID>
  </reference>
  <reference>
    <citation>Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.</citation>
    <PMID>15208174</PMID>
  </reference>
  <reference>
    <citation>Baron G, Tubach F, Ravaud P, Logeart I, Dougados M. Validation of a short form of the Western Ontario and McMaster Universities Osteoarthritis Index function subscale in hip and knee osteoarthritis. Arthritis Rheum. 2007 May 15;57(4):633-8. doi: 10.1002/art.22685.</citation>
    <PMID>17471534</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</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 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgical Procedures, Operative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Osteoarthritis, Hip</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/NCT02229279
org study id: TLM-HAD
nct id: NCT02229279
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to assess the medical and economic relevance of teleconsulting
      for Rehabilitation After Hip and Knee Surgical Procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional subscore of simplified WOMAC Scale
time frame: up to 30 days after start of rehabilitation
measure: Joint Paint measured with visual analogue scale
time frame: up to 30 days after start of rehabilitation
measure: Patient satisfaction questionnaire
time frame: The last 1 day of the rehabilitation
measure: Medical and paramedical staff satisfaction questionnaire
time frame: 6 months after enrollment of the first patient
measure: Overall costs of treatment
time frame: 6 months after enrollment of the first patient
measure: Number of hospitalizations and use of emergency units
time frame: Within 30 days after start of rehabilitation
arm group label: Teleconsulting
arm group type: Active Comparator
description: Teleconsulting
arm group label: No Teleconsulting
arm group type: No Intervention
intervention type: Device
intervention name: Teleconsulting
arm group label: Teleconsulting
other name: Telemedicine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominique Copin, MD
role: Principal Investigator
affiliation: Fondation Santé Service, Pôle Rééducation - Handicap
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: 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
citation: Tubach F, Baron G, Falissard B, Logeart I, Dougados M, Bellamy N, Ravaud P. Using patients' and rheumatologists' opinions to specify a short form of the WOMAC function subscale. Ann Rheum Dis. 2005 Jan;64(1):75-9. doi: 10.1136/ard.2003.019539.
PMID: 15608303
citation: Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.
PMID: 15208174
citation: Baron G, Tubach F, Ravaud P, Logeart I, Dougados M. Validation of a short form of the Western Ontario and McMaster Universities Osteoarthritis Index function subscale in hip and knee osteoarthritis. Arthritis Rheum. 2007 May 15;57(4):633-8. doi: 10.1002/art.22685.
PMID: 17471534
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Osteoarthritis, Hip