<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/NCT02992054</url>
  </required_header>
  <id_info>
    <org_study_id>9215</org_study_id>
    <nct_id>NCT02992054</nct_id>
  </id_info>
  <brief_title>An Innovative Occupational Program Using New Technologies (KODRO) Life of Nursing</brief_title>
  <acronym>KODRO</acronym>
  <official_title>Randomized Controlled Trial for Assessing the Effects Resulting From an Innovative Occupational Program Using New Technologies (KODRO) on Nursing Home Residents' Quality of Life (Pilot Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled trial for assessing the effects resulting from an innovative&#xD;
      occupational program using new technologies (KODRO) on nursing home residents' quality of&#xD;
      life&#xD;
&#xD;
      Context : improving quality of life (QOL) for the nursing homes residents (NHR) is a national&#xD;
      priority (2010 report from French ANESM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      KODRO stimulation program makes available stimulating activities through the use of a tactile&#xD;
      tablet computer. These tablets are linked to an internet-based service platform The project&#xD;
      main objective is to demonstrate by way of a randomized controlled trial the significance of&#xD;
      the improvement of residents' QOL achieved by 2 one-hour KODRO sessions per week during 6&#xD;
      months (KODRO nursing homes) when compared with the usual stimulation activity program&#xD;
      (nursing homes &quot;controls&quot;) (difference for the QOL-AD score &gt; 2 points).At last, the&#xD;
      objective of the study is also observational, i.e. to determine the quality of life of NHR at&#xD;
      baseline, in its differents aspects.Subjects &amp; methods Analysis will be conducted to compare&#xD;
      quantitative parameters at the beginning of the trial to verify the comparability of the two&#xD;
      groups and of the mean average change between parameters measured at baseline, 3 months, and&#xD;
      6 months in both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The number of patients were enough for statistic treatment&#xD;
  </why_stopped>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Quality of life: QOL-AD score: questionnaire</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Different aspects of QOL score: questionnaire</measure>
    <time_frame>6 Months</time_frame>
    <description>Measurement of apathy&#xD;
depression&#xD;
anxiety&#xD;
autonomy&#xD;
self-esteem&#xD;
overall well-being&#xD;
behavioral problems&#xD;
psychotropic medication use</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">239</enrollment>
  <condition>Home Residents</condition>
  <arm_group>
    <arm_group_label>Stimulating activities with the use of tactile tablet computer</arm_group_label>
    <description>Stimulating activities through the use of a tactile tablet computer. These tablets are linked to an internet-based service platform and offer a very easy and intuitive interaction for the user, even when this person is suffering from a moderate cognitive and/or physical impairment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stimulating activities with usual stimulation activity program</arm_group_label>
    <description>No Stimulating activities through the use of a tactile tablet computer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>stimulating activities</intervention_name>
    <arm_group_label>Stimulating activities with the use of tactile tablet computer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Nursing home residents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nursing home residents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to participate in the ocupational therapy using KODRO (Demential end of life&#xD;
             ...)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Months</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hubert BLAIN, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02992054
org study id: 9215
nct id: NCT02992054
lead sponsor: 
has dmc: No
Randomized controlled trial for assessing the effects resulting from an innovative
      occupational program using new technologies (KODRO) on nursing home residents' quality of
      life

      Context : improving quality of life (QOL) for the nursing homes residents (NHR) is a national
      priority (2010 report from French ANESM).
KODRO stimulation program makes available stimulating activities through the use of a tactile
      tablet computer. These tablets are linked to an internet-based service platform The project
      main objective is to demonstrate by way of a randomized controlled trial the significance of
      the improvement of residents' QOL achieved by 2 one-hour KODRO sessions per week during 6
      months (KODRO nursing homes) when compared with the usual stimulation activity program
      (nursing homes "controls") (difference for the QOL-AD score > 2 points).At last, the
      objective of the study is also observational, i.e. to determine the quality of life of NHR at
      baseline, in its differents aspects.Subjects & methods Analysis will be conducted to compare
      quantitative parameters at the beginning of the trial to verify the comparability of the two
      groups and of the mean average change between parameters measured at baseline, 3 months, and
      6 months in both groups.
observational model: Case-Control
time perspective: Prospective
measure: Quality of life: QOL-AD score: questionnaire
time frame: 6 months
measure: Different aspects of QOL score: questionnaire
time frame: 6 Months
description: Measurement of apathy
depression
anxiety
autonomy
self-esteem
overall well-being
behavioral problems
psychotropic medication use
arm group label: Stimulating activities with the use of tactile tablet computer
description: Stimulating activities through the use of a tactile tablet computer. These tablets are linked to an internet-based service platform and offer a very easy and intuitive interaction for the user, even when this person is suffering from a moderate cognitive and/or physical impairment.
arm group label: Stimulating activities with usual stimulation activity program
description: No Stimulating activities through the use of a tactile tablet computer
intervention type: Other
intervention name: stimulating activities
arm group label: Stimulating activities with the use of tactile tablet computer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Months
maximum age: 100 Years
healthy volunteers: No
last name: Hubert BLAIN, MD, PHD
role: Principal Investigator
affiliation: University Hospital, Montpellier
responsible party type: Sponsor
sharing ipd: No