<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/NCT01697553</url>
  </required_header>
  <id_info>
    <org_study_id>I11 001</org_study_id>
    <nct_id>NCT01697553</nct_id>
  </id_info>
  <brief_title>Home-Based Technologies Coupled to Teleassistance Service in the Elderly</brief_title>
  <acronym>DOMOLIM</acronym>
  <official_title>Home-Based Technologies Coupled to Teleassistance Service: Efficacy for Preventing Falls at Home in Frail Elderly Population Losing Autonomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Limoges</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The growth of the elderly population is associated with the autonomy failure and the increase&#xD;
      of dependence problems. Fall incidents are the third cause of chronic disablement in older&#xD;
      persons and are one of the major risk factors for entering in dependence.&#xD;
&#xD;
      The recent progress in home technologies and medical care are opportunities to search how to&#xD;
      apply these tools to reduce and prevent falling at home.&#xD;
&#xD;
      The purpose of this study is to evaluate the cost effectiveness of simple home automation&#xD;
      pack coupled to teleassistance service for preventing home falls in frail elderly population.&#xD;
&#xD;
      1200 patients will be enrolled and randmosied within two arms:&#xD;
&#xD;
        -  home with automation pack coupled to teleassistance service&#xD;
&#xD;
        -  home without this technology&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is one of the first European randomized studies using the criteria MAST (Model for&#xD;
      Assessment of Telemedicine) for medico-economic evaluation of technology solutions for the&#xD;
      prevention and care in the elderly. The medico-economic evaluation of the overall&#xD;
      contribution of home automation kit associated with telecare will be conducted in accordance&#xD;
      with the recommendations of the research program Renewing Health FP7 the European Union. This&#xD;
      program has developed an analytical model common to all evaluations of telemedicine&#xD;
      applications that have an impact on health.&#xD;
&#xD;
      . The home-based technology in this study will be a simple home automation pack coupled to&#xD;
      teleassistance service. The automation pack will include: a remote intercom, an electronic&#xD;
      bracelet or pendentive, a pull shower in the bathroom, a light path, a smoke detector and a&#xD;
      gas detector in the kitchen. The central hotline will provide telephone support at all times.&#xD;
&#xD;
      Intercom is a remote transmitter which enables the platform to provide remote assistance with&#xD;
      the elderly at home.&#xD;
&#xD;
      Each person will have electronic bracelet or pendentive with a medallion which will be&#xD;
      provided with the dialer. It is a system that allows remote assistance to the elderly by&#xD;
      pressing the central medallion of the device to request assistance or report a dangerous&#xD;
      situation (risk of falling, or fall) to the platform of teleassistance.&#xD;
&#xD;
      The bathroom alarm zipper is a device installed in the shower that allows subjects to use it&#xD;
      when at risk of falling or fall detection. The shower is a high risk of fall for the elderly&#xD;
      due to movements very often results in an imbalance of seniors already weakened by aging.&#xD;
&#xD;
      The light path is a 1.5 m device installed near the bed and turns automatically on when the&#xD;
      person sets foot on the ground. It can provide adapted visibility by showing the right path&#xD;
      and improving consciousness.&#xD;
&#xD;
      The smoke and gas detector are devices installed on the ceiling of the kitchen. They allow&#xD;
      respectively detecting abnormally high rates of smoke or a gas leak in the house or&#xD;
      apartment.&#xD;
&#xD;
      The teleassistance platform is a central technical hotline located in Creuse area. It is&#xD;
      functional at any time. All electronic devices are connected to the plant. An alert is&#xD;
      signaled by an alarm, involving an immediate phone call to the resident of the house to&#xD;
      assess the situation. The resulting actions taken are either reassuring the person, giving&#xD;
      directions to the person or sending a message to aid in the event ascertained or suspected.&#xD;
&#xD;
      A monthly questionnary should be filled by patients.&#xD;
&#xD;
      Primary outcome:&#xD;
&#xD;
      The main judgment criterion will be the cumulated incidence of home falls requiring emergency&#xD;
      admission.&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
        1. Changes score ISO profile resource according to SMAF scale,&#xD;
&#xD;
        2. Proportion of participants with regular physical activity&#xD;
&#xD;
        3. Effect on admissions in institutions (nursing homes or senior residential care)&#xD;
&#xD;
        4. Time before management of stroke and the length of stay in rehabilitation unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of home falls requiring emergency admission</measure>
    <time_frame>at 12 months</time_frame>
    <description>The cumulated incidence of home falls requiring emergency admission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes score ISO profile resource according to SMAF scale</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with regular physical activity</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on admissions in institutions (nursing homes or senior residential care)</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time before management of stroke and the length of stay in rehabilitation unit</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Disablement in the Elderly</condition>
  <arm_group>
    <arm_group_label>Home automation pack coupled to teleassistance service</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Home without automation pack coupled to teleassistance service</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>home automation pack coupled to teleassistance service</intervention_name>
    <arm_group_label>Home automation pack coupled to teleassistance service</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home without automation pack coupled to teleassistance service</intervention_name>
    <arm_group_label>Home without automation pack coupled to teleassistance service</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 65 or over&#xD;
&#xD;
          -  Living at least for 1 year in the department of Creuse&#xD;
&#xD;
          -  Frail elderly or pre-frail according to the criteria of Fried&#xD;
&#xD;
          -  Patient with autonomy enough to get out of bed&#xD;
&#xD;
          -  Having a cognitive level acceptable (MMS ≥ 10)&#xD;
&#xD;
          -  Place of life arranged and adapted to the installation of the DSTA&#xD;
&#xD;
          -  Consentbsigned by the patient and / or its trusted person or his legal representative&#xD;
&#xD;
          -  Affiliation or beneficiary of a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under guardianship or protection of justice&#xD;
&#xD;
          -  patient home already equiped with automation pack different from theone of the&#xD;
             experiment&#xD;
&#xD;
          -  People who can not read or write&#xD;
&#xD;
          -  Diseases involving life-threatening in the short term (&lt;1 year)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thierry DANTOINE, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU Limoges</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thierry DANTOINE, MD</last_name>
    <phone>0555058621</phone>
    <email>thierry.dantoine@unilim.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Achille TCHALLA, MD</last_name>
    <phone>055556957</phone>
    <email>achille.tchalla@unilim.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CH Aubusson</name>
      <address>
        <city>Aubusson</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH Bourganeuf</name>
      <address>
        <city>Bourganeuf</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH de Gueret</name>
      <address>
        <city>Gueret</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thierry DANTOINE, MD</last_name>
    </contact>
    <investigator>
      <last_name>COLLINS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>April 1, 2015</last_update_submitted>
  <last_update_submitted_qc>April 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 3, 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/NCT01697553
org study id: I11 001
nct id: NCT01697553
lead sponsor: 
has dmc: No
The growth of the elderly population is associated with the autonomy failure and the increase
      of dependence problems. Fall incidents are the third cause of chronic disablement in older
      persons and are one of the major risk factors for entering in dependence.

      The recent progress in home technologies and medical care are opportunities to search how to
      apply these tools to reduce and prevent falling at home.

      The purpose of this study is to evaluate the cost effectiveness of simple home automation
      pack coupled to teleassistance service for preventing home falls in frail elderly population.

      1200 patients will be enrolled and randmosied within two arms:

        -  home with automation pack coupled to teleassistance service

        -  home without this technology
This study is one of the first European randomized studies using the criteria MAST (Model for
      Assessment of Telemedicine) for medico-economic evaluation of technology solutions for the
      prevention and care in the elderly. The medico-economic evaluation of the overall
      contribution of home automation kit associated with telecare will be conducted in accordance
      with the recommendations of the research program Renewing Health FP7 the European Union. This
      program has developed an analytical model common to all evaluations of telemedicine
      applications that have an impact on health.

      . The home-based technology in this study will be a simple home automation pack coupled to
      teleassistance service. The automation pack will include: a remote intercom, an electronic
      bracelet or pendentive, a pull shower in the bathroom, a light path, a smoke detector and a
      gas detector in the kitchen. The central hotline will provide telephone support at all times.

      Intercom is a remote transmitter which enables the platform to provide remote assistance with
      the elderly at home.

      Each person will have electronic bracelet or pendentive with a medallion which will be
      provided with the dialer. It is a system that allows remote assistance to the elderly by
      pressing the central medallion of the device to request assistance or report a dangerous
      situation (risk of falling, or fall) to the platform of teleassistance.

      The bathroom alarm zipper is a device installed in the shower that allows subjects to use it
      when at risk of falling or fall detection. The shower is a high risk of fall for the elderly
      due to movements very often results in an imbalance of seniors already weakened by aging.

      The light path is a 1.5 m device installed near the bed and turns automatically on when the
      person sets foot on the ground. It can provide adapted visibility by showing the right path
      and improving consciousness.

      The smoke and gas detector are devices installed on the ceiling of the kitchen. They allow
      respectively detecting abnormally high rates of smoke or a gas leak in the house or
      apartment.

      The teleassistance platform is a central technical hotline located in Creuse area. It is
      functional at any time. All electronic devices are connected to the plant. An alert is
      signaled by an alarm, involving an immediate phone call to the resident of the house to
      assess the situation. The resulting actions taken are either reassuring the person, giving
      directions to the person or sending a message to aid in the event ascertained or suspected.

      A monthly questionnary should be filled by patients.

      Primary outcome:

      The main judgment criterion will be the cumulated incidence of home falls requiring emergency
      admission.

      Secondary outcomes:

        1. Changes score ISO profile resource according to SMAF scale,

        2. Proportion of participants with regular physical activity

        3. Effect on admissions in institutions (nursing homes or senior residential care)

        4. Time before management of stroke and the length of stay in rehabilitation unit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: incidence of home falls requiring emergency admission
time frame: at 12 months
description: The cumulated incidence of home falls requiring emergency admission.
measure: Changes score ISO profile resource according to SMAF scale
time frame: at 12 months
measure: Proportion of participants with regular physical activity
time frame: at 12 months
measure: Effect on admissions in institutions (nursing homes or senior residential care)
time frame: at 12 months
measure: Time before management of stroke and the length of stay in rehabilitation unit
time frame: at 12 months
arm group label: Home automation pack coupled to teleassistance service
arm group type: Experimental
arm group label: Home without automation pack coupled to teleassistance service
arm group type: Active Comparator
intervention type: Other
intervention name: home automation pack coupled to teleassistance service
arm group label: Home automation pack coupled to teleassistance service
intervention type: Other
intervention name: Home without automation pack coupled to teleassistance service
arm group label: Home without automation pack coupled to teleassistance service
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Thierry DANTOINE, MD
role: Study Chair
affiliation: CHU Limoges
last name: Thierry DANTOINE, MD
phone: 0555058621
email: thierry.dantoine@unilim.fr
last name: Achille TCHALLA, MD
phone: 055556957
email: achille.tchalla@unilim.fr
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor