<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/NCT01689948</url>
  </required_header>
  <id_info>
    <org_study_id>RC12_0080</org_study_id>
    <nct_id>NCT01689948</nct_id>
  </id_info>
  <brief_title>Alzheimer Disease : Rehabilitation's Intervention at Home</brief_title>
  <acronym>pré MATAPA</acronym>
  <official_title>Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its&#xD;
      prevalence and its medical and social consequences, AD represents a dual challenge to public&#xD;
      health and society. The elderly want to stay in their homes even when their lives are altered&#xD;
      by a chronic progressive disease. Their caregivers claim in turn a support at home. But this&#xD;
      desire is questioned because of the characteristics of the disease, e.g. the altered&#xD;
      relational function by the cognitive impairment and the behavioural disorders associated.&#xD;
&#xD;
      Outpatients non-drug therapies represent a potential support that adapts to patient with an&#xD;
      AD or mixed dementia, especially in their milder forms.&#xD;
&#xD;
      The aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention&#xD;
      at home and its acceptability by both the patient and the caregiver.&#xD;
&#xD;
      The study of its efficiency in terms of autonomy will be the next step.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protocol is based on weekly rehabilitation's intervention at home. All home visits and&#xD;
      assessments of the patient and his caregiver will be made by the rehabilitation's therapist&#xD;
      himself.&#xD;
&#xD;
      Twelve weekly interventions at home are planed. The first five are needed to define a&#xD;
      realistic and achievable goal of treatment which is accepted by the dyad and the therapist.&#xD;
      The following seven interventions will achieve this goal by rehabilitation's intervention&#xD;
      (e.g. occupational therapy, psychomotor approach).&#xD;
&#xD;
      Four filmed sessions for dyad's assessment are planned (at inclusion, at weeks 5 and 12 after&#xD;
      inclusion and 3 months after the last intervention).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    difficulties of recruitment&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)</measure>
    <time_frame>27 weeks</time_frame>
    <description>The main objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)</measure>
    <time_frame>5 weeks</time_frame>
    <description>This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the fifth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)</measure>
    <time_frame>13 weeks</time_frame>
    <description>This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)</measure>
    <time_frame>27 weeks</time_frame>
    <description>This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)</measure>
    <time_frame>5 weeks</time_frame>
    <description>This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)</measure>
    <time_frame>13 weeks</time_frame>
    <description>This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 12 weeks later (meaning after the last of the twelfth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Zarit's scale (caregiver burden)</measure>
    <time_frame>13 weeks</time_frame>
    <description>This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Zarit's scale (caregiver burden)</measure>
    <time_frame>27 weeks</time_frame>
    <description>This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Zarit's scale (caregiver burden)</measure>
    <time_frame>5 weeks</time_frame>
    <description>This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol consumption for the patient and the caregiver</measure>
    <time_frame>27 weeks</time_frame>
    <description>This objective is to compare the alcohol consumption for the patient and the caregiver observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Mini Mental State Examination (MMSE)(meaning evaluation of patient's cognitive impairment)</measure>
    <time_frame>27 weeks</time_frame>
    <description>This objective is to compare the mean scores of Mini Mental State Examination (MMSE) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the mean scores of Goal Attainment scales (GAS) (meaning evaluation of the satisfaction of the patient and of her/his caregiver)</measure>
    <time_frame>27 weeks</time_frame>
    <description>This objective is to compare the mean scores of Goal Attainment Scales (GAS) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Home rehabilitation therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weekly sessions of Home rehabilitation therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home rehabilitation therapy</intervention_name>
    <description>12 sessions of home rehabilitation therapy</description>
    <arm_group_label>Home rehabilitation therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient's inclusion criteria:&#xD;
&#xD;
          -  Aged 65 and over&#xD;
&#xD;
          -  AD or mixed dementia (DSM IV TR criteria), documented by a neuropsychological&#xD;
             assessment and a brain imaging&#xD;
&#xD;
          -  Living at home&#xD;
&#xD;
          -  Having a caregiver (more than 2 visits per week)&#xD;
&#xD;
          -  Agreement for the study&#xD;
&#xD;
        Caregiver's inclusion criteria :&#xD;
&#xD;
          -  More than 2 patient's visits per week&#xD;
&#xD;
          -  Agreement for the study&#xD;
&#xD;
        Patient's exclusion criteria:&#xD;
&#xD;
          -  Life expectancy less than 1 year&#xD;
&#xD;
          -  Guardianship&#xD;
&#xD;
          -  Already having a rehabilitation program's therapy&#xD;
&#xD;
          -  Participation in a pharmacological study&#xD;
&#xD;
        Caregiver's exclusion criteria:&#xD;
&#xD;
        - Medical condition requiring regular care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilles Berrut, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bellier Hospital, CHU of Nantes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bellier Hospital, CHU of Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Home care, rehabilitation therapy, Alzheimer's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT01689948
org study id: RC12_0080
nct id: NCT01689948
lead sponsor: 
has dmc: No
Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its
      prevalence and its medical and social consequences, AD represents a dual challenge to public
      health and society. The elderly want to stay in their homes even when their lives are altered
      by a chronic progressive disease. Their caregivers claim in turn a support at home. But this
      desire is questioned because of the characteristics of the disease, e.g. the altered
      relational function by the cognitive impairment and the behavioural disorders associated.

      Outpatients non-drug therapies represent a potential support that adapts to patient with an
      AD or mixed dementia, especially in their milder forms.

      The aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention
      at home and its acceptability by both the patient and the caregiver.

      The study of its efficiency in terms of autonomy will be the next step.
The protocol is based on weekly rehabilitation's intervention at home. All home visits and
      assessments of the patient and his caregiver will be made by the rehabilitation's therapist
      himself.

      Twelve weekly interventions at home are planed. The first five are needed to define a
      realistic and achievable goal of treatment which is accepted by the dyad and the therapist.
      The following seven interventions will achieve this goal by rehabilitation's intervention
      (e.g. occupational therapy, psychomotor approach).

      Four filmed sessions for dyad's assessment are planned (at inclusion, at weeks 5 and 12 after
      inclusion and 3 months after the last intervention).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
time frame: 27 weeks
description: The main objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
time frame: 5 weeks
description: This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the fifth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Instrumental Activities of Daily Living (IADL)
time frame: 13 weeks
description: This objective is to compare the mean scores of Instrumental Activities of Daily Living (IADL) observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
time frame: 27 weeks
description: This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
time frame: 5 weeks
description: This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Neuro Psychiatric Inventory (NPI)
time frame: 13 weeks
description: This objective is to compare the mean scores of Neuro Psychiatric Inventory(NPI) observed at inclusion (day 0) with those observed 12 weeks later (meaning after the last of the twelfth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Zarit's scale (caregiver burden)
time frame: 13 weeks
description: This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 13 weeks later (meaning after the twelfth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Zarit's scale (caregiver burden)
time frame: 27 weeks
description: This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Zarit's scale (caregiver burden)
time frame: 5 weeks
description: This objective is to compare the mean scores of Zarit's scale observed at inclusion (day 0) with those observed 5 weeks later (meaning after the last of the fifth weekly session of at home rehabilitation therapy).
measure: Alcohol consumption for the patient and the caregiver
time frame: 27 weeks
description: This objective is to compare the alcohol consumption for the patient and the caregiver observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Mini Mental State Examination (MMSE)(meaning evaluation of patient's cognitive impairment)
time frame: 27 weeks
description: This objective is to compare the mean scores of Mini Mental State Examination (MMSE) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
measure: Evaluation of the mean scores of Goal Attainment scales (GAS) (meaning evaluation of the satisfaction of the patient and of her/his caregiver)
time frame: 27 weeks
description: This objective is to compare the mean scores of Goal Attainment Scales (GAS) observed at inclusion (day 0) with those observed 27 weeks later (meaning 3 months after the last of the twelfth weekly session of at home rehabilitation therapy).
arm group label: Home rehabilitation therapy
arm group type: Experimental
description: 12 weekly sessions of Home rehabilitation therapy
intervention type: Behavioral
intervention name: Home rehabilitation therapy
description: 12 sessions of home rehabilitation therapy
arm group label: Home rehabilitation therapy
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gilles Berrut, Pr
role: Principal Investigator
affiliation: Bellier Hospital, CHU of Nantes
facility: 
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease