<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/NCT02256202</url>
  </required_header>
  <id_info>
    <org_study_id>EDCINPT</org_study_id>
    <nct_id>NCT02256202</nct_id>
  </id_info>
  <brief_title>Quality Assurance of Electronic Data Capturing (EDC) in Pain Treatment</brief_title>
  <official_title>Pilot Study of Quality Assurance in Interventional Pain Therapy in the Lumbal Spinal Column. Non-randomised, Evaluative, Multicentral Study Concerning the Applicability of a Tablet-PC.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qualitouch-HC Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mundipharma Pte Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Qualitouch-HC Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are actually no standardized quality assurance procedures included in pain treatment&#xD;
      processes.&#xD;
&#xD;
      In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested&#xD;
      in pain therapy centres using the validated questionnaire &quot;Activity Index&quot;. The acceptance of&#xD;
      electronic data capturing is tested in patients and therapy teams (doctors and nurses).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regarding the demand for a duly documented efficacy of the therapy applied, a standardized&#xD;
      procedure is imperative to show the medical and economic advantages of a given therapy. To&#xD;
      obtain valid results, it is necessary to use a standardized process, monitored with a&#xD;
      validated questionnaire.&#xD;
&#xD;
      In this multi-center study the Activity Index Questionnaire will be tested regarding its&#xD;
      outcome quality regarding usability and patient acceptance. Each center collects data of 10&#xD;
      patients with injection pain therapy. Each patient is interviewed twice and after the 2nd&#xD;
      interview each patient will fill out a feasibility questionnaire. During the whole study, the&#xD;
      use and consumption of oral analgetic drugs are monitored in a diary. The statistical&#xD;
      Analysis is done descriptive. Before entering the study, each patient has to give informed&#xD;
      consent to participate. National Registration Guidelines for post market surveillance will be&#xD;
      obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Tablet-PC in interviewing pain patients</measure>
    <time_frame>6-12 months</time_frame>
    <description>The feasibility of the Tablet-PC in EDC will be assessed by standardized interviews (three times) of the study doctor, the study nurse and the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Problems in application of EDC in Tablet-PC</measure>
    <time_frame>12 months</time_frame>
    <description>We measure the Problems of the Application of the EDC, e.g. Patient can't ush the button to answer the questions, e.g. some patients do not understand a question. The answers are usually given by Likert scales.</description>
  </secondary_outcome>
  <enrollment type="Actual">64</enrollment>
  <condition>Pain</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Monitoring interviews to show medical and economic advantages of given therapy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Back pain patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness for therapeutic pain injection in lumbar spine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment, technical Problems in interviewing patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Theiler</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stadtspital Triemli Zurich, Department of Rheumatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stadtspital Triemli</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8063</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>October 22, 2015</last_update_submitted>
  <last_update_submitted_qc>October 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02256202
org study id: EDCINPT
nct id: NCT02256202
lead sponsor: 
collaborator: 
has dmc: No
There are actually no standardized quality assurance procedures included in pain treatment
      processes.

      In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested
      in pain therapy centres using the validated questionnaire "Activity Index". The acceptance of
      electronic data capturing is tested in patients and therapy teams (doctors and nurses).
Regarding the demand for a duly documented efficacy of the therapy applied, a standardized
      procedure is imperative to show the medical and economic advantages of a given therapy. To
      obtain valid results, it is necessary to use a standardized process, monitored with a
      validated questionnaire.

      In this multi-center study the Activity Index Questionnaire will be tested regarding its
      outcome quality regarding usability and patient acceptance. Each center collects data of 10
      patients with injection pain therapy. Each patient is interviewed twice and after the 2nd
      interview each patient will fill out a feasibility questionnaire. During the whole study, the
      use and consumption of oral analgetic drugs are monitored in a diary. The statistical
      Analysis is done descriptive. Before entering the study, each patient has to give informed
      consent to participate. National Registration Guidelines for post market surveillance will be
      obtained.
observational model: Cohort
time perspective: Prospective
measure: Feasibility of Tablet-PC in interviewing pain patients
time frame: 6-12 months
description: The feasibility of the Tablet-PC in EDC will be assessed by standardized interviews (three times) of the study doctor, the study nurse and the patient.
measure: Problems in application of EDC in Tablet-PC
time frame: 12 months
description: We measure the Problems of the Application of the EDC, e.g. Patient can't ush the button to answer the questions, e.g. some patients do not understand a question. The answers are usually given by Likert scales.
intervention type: Other
intervention name: Interview
description: Monitoring interviews to show medical and economic advantages of given therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Theiler
role: Principal Investigator
affiliation: Stadtspital Triemli Zurich, Department of Rheumatology
facility: 
country: Switzerland
responsible party type: Sponsor