<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/NCT02255058</url>
  </required_header>
  <id_info>
    <org_study_id>Linde001</org_study_id>
    <nct_id>NCT02255058</nct_id>
  </id_info>
  <brief_title>MIND Score for Prolonged Mechanical Ventilation</brief_title>
  <acronym>MIND</acronym>
  <official_title>Psychometric Validation of the Multi-INdependency Dimensions (MIND) Score for Patients Under Prolonged Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linde AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Linde AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It was decided to develop a comprehensive disability score specifically designed for patients&#xD;
      receiving prolonged mechanical ventilation (PMV); the collection of information included in&#xD;
      the score should not impose any further intervention beyond what is routinely performed. So a&#xD;
      new questionnaire was created (called the Multi-INdependency Dimensions (MIND) that included&#xD;
      3 sections (nurse, physiotherapist and medical doctor), 11 categories and 18 items. Each&#xD;
      question was adapted to have a 5 item Likert scale.&#xD;
&#xD;
      The primary objective of the study will be to evaluate the psychometric performance of the&#xD;
      MIND score in terms of validity, reliability and sensitivity to change over time. The&#xD;
      secondary objective will be to assess the inclusion of biological markers on the overall&#xD;
      performance of the MIND score&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following recruitment all participants will be assessed by a medical doctor or respiratory&#xD;
      therapist (trained on the study) who will fill out the MIND questionnaire on admission and&#xD;
      make sure the other scales/questionnaires are also completed. On the same day of the&#xD;
      collection of MIND, MRC score for quadriceps and biceps strength, Sequential Organ Failure&#xD;
      Assessment (SOFA) score, Glasgow coma scale, Hospital Anxiety-depression scale (HADS),&#xD;
      EuroQol-5D, Gussago Dependence Nursing Scale (GNS) will be also gathered. After 1 day and 30&#xD;
      days the MIND questionnaire will be also evaluated. Index of ADL-(Katz index) will be&#xD;
      evaluated on discharge as well as weaning rate and survival.&#xD;
&#xD;
      Sample Size Determination&#xD;
&#xD;
      Based on the method of Rouquette A et al (1) we estimated a sample size of 200 patients to&#xD;
      allow for the Rasch modelling to be applied.&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      Assessment of construct validity:&#xD;
&#xD;
      Confirmation of the structure (e.g. multitrait analysis), clinical validity (comparison of&#xD;
      disability score according to external clinical criteria)&#xD;
&#xD;
      Assessment of reliability:&#xD;
&#xD;
      Internal consistency reliability (using Cronbach's alpha), test-retest reliability (using&#xD;
      intraclass correlations)&#xD;
&#xD;
      Assessment of sensitivity to change over time:&#xD;
&#xD;
      Comparison of change in disability score according to change in external clinical criteria&#xD;
      Guidance for interpretation of disability score: Estimation of thresholds for patients'&#xD;
      classification&#xD;
&#xD;
      1-Rouquette A, Falissard B Sample size requirements for the internal validation of&#xD;
      psychiatric scales Int J Methods Psychiatr Res. 2011 Dec;20(4):235-49. doi: 10.1002/mpr.352.&#xD;
      Epub 2011 Oct 24.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>To evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the inclusion of biological markers on the overall performance of the MIND score</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">129</enrollment>
  <condition>Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>The study is a Prospective observational cohort study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with Prolonged mechanical Ventilation and a Diagnosis of Acute lung injury,&#xD;
        COPD/Chronic Lung Disease, Neuromuscular Disorders, Post-Operative, Cardiovascular&#xD;
        Disorders, Trauma, Other.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with Prolonged mechanical Ventilation and a Diagnosis of Acute lung&#xD;
             injury, COPD/Chronic Lung Disease, Neuromuscular Disorders, Post-Operative,&#xD;
             Cardiovascular Disorders, Trauma, Other.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Expected length of stay &lt;48h, unable to achieve consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joao C Winck, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Linde AG, Global Business Unit Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>REMEO El Pilar</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>REMEO Bogota</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>REMEO Medellin</name>
      <address>
        <city>Medellin</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>REMEO Centre</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>REMEO Mahlow</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Colombia</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>February 27, 2015</last_update_submitted>
  <last_update_submitted_qc>February 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 2, 2015</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>Neuromuscular Diseases</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/NCT02255058
org study id: Linde001
nct id: NCT02255058
lead sponsor: 
has dmc: No
It was decided to develop a comprehensive disability score specifically designed for patients
      receiving prolonged mechanical ventilation (PMV); the collection of information included in
      the score should not impose any further intervention beyond what is routinely performed. So a
      new questionnaire was created (called the Multi-INdependency Dimensions (MIND) that included
      3 sections (nurse, physiotherapist and medical doctor), 11 categories and 18 items. Each
      question was adapted to have a 5 item Likert scale.

      The primary objective of the study will be to evaluate the psychometric performance of the
      MIND score in terms of validity, reliability and sensitivity to change over time. The
      secondary objective will be to assess the inclusion of biological markers on the overall
      performance of the MIND score
Following recruitment all participants will be assessed by a medical doctor or respiratory
      therapist (trained on the study) who will fill out the MIND questionnaire on admission and
      make sure the other scales/questionnaires are also completed. On the same day of the
      collection of MIND, MRC score for quadriceps and biceps strength, Sequential Organ Failure
      Assessment (SOFA) score, Glasgow coma scale, Hospital Anxiety-depression scale (HADS),
      EuroQol-5D, Gussago Dependence Nursing Scale (GNS) will be also gathered. After 1 day and 30
      days the MIND questionnaire will be also evaluated. Index of ADL-(Katz index) will be
      evaluated on discharge as well as weaning rate and survival.

      Sample Size Determination

      Based on the method of Rouquette A et al (1) we estimated a sample size of 200 patients to
      allow for the Rasch modelling to be applied.

      Statistical analysis

      Assessment of construct validity:

      Confirmation of the structure (e.g. multitrait analysis), clinical validity (comparison of
      disability score according to external clinical criteria)

      Assessment of reliability:

      Internal consistency reliability (using Cronbach's alpha), test-retest reliability (using
      intraclass correlations)

      Assessment of sensitivity to change over time:

      Comparison of change in disability score according to change in external clinical criteria
      Guidance for interpretation of disability score: Estimation of thresholds for patients'
      classification

      1-Rouquette A, Falissard B Sample size requirements for the internal validation of
      psychiatric scales Int J Methods Psychiatr Res. 2011 Dec;20(4):235-49. doi: 10.1002/mpr.352.
      Epub 2011 Oct 24.
observational model: Cohort
time perspective: Prospective
measure: To evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time
time frame: 6 Months
measure: To assess the inclusion of biological markers on the overall performance of the MIND score
time frame: 6 Months
intervention type: Other
intervention name: No intervention
description: The study is a Prospective observational cohort study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Joao C Winck, MD,PhD
role: Study Director
affiliation: Linde AG, Global Business Unit Healthcare
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Colombia
country: Germany
responsible party type: Sponsor
mesh term: Neuromuscular Diseases