xml: <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/NCT05982145</url>
    </required_header>
    <id_info>
      <org_study_id>GA-2021-04</org_study_id>
      <nct_id>NCT05982145</nct_id>
    </id_info>
    <brief_title>The Use of Compression in Institutions and at People's Homes</brief_title>
    <official_title>The Use of Compression in Institutions and at People's Homes: A Satisfaction Study, Representations, Opinions and Expectations of Users and Caregivers and Creation of a Morphological Database. A Qualitative and Quantitative Multicentric Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sigvaris Corporation</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Gerontopole Auvergne Rhone-Alpes (AURA)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The compression therapy is a main treatment for chronic venous disease and its different&#xD;
        phases. It has proven its effectiveness and usefulness in preventive phase and curative&#xD;
        phase. Gérontopôle AURA leads with his partner Sigvaris a large study about the compression&#xD;
        in institutions and at patient's homes. Indeed, through 3 studies, the mains goals are to&#xD;
        identify the facilities and difficulties about the use of the actual tools. The final aim is&#xD;
        to propose a future compression device wich could be adapted and that responds to the needs&#xD;
        of users and the realities of the field. First study: Construction of a representative&#xD;
        morphological database of people who are 60 years old and older. Indeed, the actually sizing&#xD;
        tables are not specifics so not adapted to the morphology of the wearer. This can have an&#xD;
        impact on the effectiveness of the treatment and the comfort of the patient. Second study:&#xD;
        Have a deep comprehension about the pathway of the compression stockings and bandage in&#xD;
        public and private establishment specifically retirements homes for dependant elderly people&#xD;
        and hospital. The objectives are to understand and identify the role of health professionals&#xD;
        from prescription to implementation to the compressive tools and have their feeds backs.&#xD;
        Moreover, the goal is to collect the uses and constraints related to compression systems and&#xD;
        to identify the possible improvements, needs and hindrances in link with compressions&#xD;
        products. Third study: Study of acceptability of a new adjustable compression solution for&#xD;
        venous ulcers. The main goal is to understand the needs and expectations by the users and to&#xD;
        know if a new adjustable compression system could be accepted by them. For that, it's&#xD;
        important to have a feed back about the use of the compression by the caregivers, medical&#xD;
        staff and patients and evaluate the comfort about the use of the compression at patient's&#xD;
        home and in institutions. Getting their advices, opinions are necessary too.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The mains goals are to identify the facilities and difficulties about the use of the actual&#xD;
        tools. The final aim is to propose a future compression device wich could be adapted and that&#xD;
        responds to the needs of users and the realities of the field.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 14, 2020</start_date>
    <completion_date type="Actual">June 30, 2021</completion_date>
    <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>data about leg's length</measure>
      <time_frame>Months 5</time_frame>
      <description>Collect representative data about leg's length. Measure by questionary and taking measures</description>
    </primary_outcome>
    <primary_outcome>
      <measure>data about measure of hydration</measure>
      <time_frame>Months 5</time_frame>
      <description>Collect representative data about measure of hydration. Measure by questionary and taking measures</description>
    </primary_outcome>
    <primary_outcome>
      <measure>data about the Group Iso Resource (GIR)</measure>
      <time_frame>Months 5</time_frame>
      <description>Collect representative data about the Group Iso Resource (GIR). Measure by questionary and taking measures</description>
    </primary_outcome>
    <primary_outcome>
      <measure>data about the capacity of the person to getting out of the bed.</measure>
      <time_frame>Months 5</time_frame>
      <description>Collect representative data about the capacity of the person to getting out of the bed. Measure by questionary and taking measures</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>caregivers's experiences and representations about compression systems of venous leg ulcer</measure>
      <time_frame>Months 6</time_frame>
      <description>Measure by individuals interviews</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patients' experiences and representations about compression systems of venous leg ulcer</measure>
      <time_frame>Months 6</time_frame>
      <description>Measure by individuals interviews</description>
    </secondary_outcome>
    <other_outcome>
      <measure>caregivers's in institution experiences and representations about the pathway of compression systems in institution</measure>
      <time_frame>Months 18</time_frame>
      <description>Measure by Focus Groups</description>
    </other_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Actual">39</enrollment>
    <condition>Aging</condition>
    <arm_group>
      <arm_group_label>Patients who are 60 years old and over</arm_group_label>
      <description>Patients who are 60 years old and over had a questionary and a measure of their leg's length</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients with / or had venous leg ulcers</arm_group_label>
      <description>Patients with / or had venous leg ulcers actually have individual interviews</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Caregivers who treat patients with venous leg ulcers (except nursing homes)</arm_group_label>
      <description>Caregivers who treat patients with venous leg ulcers (except nursing homes) actually have individual interviews</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Caregivers in nursing homes for dependant elderly people and institutions like hospital</arm_group_label>
      <description>Caregivers in nursing homes for dependant elderly people and institutions like hospital actually have focus groups</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Individual interviews</intervention_name>
      <description>Identify the needs and expectations of the users about the compression therapy; Identify the possible facilities and difficulties in link with the management of the venous leg ulcers; Identify care experiences; Identify experiences about the actual compressions systems</description>
      <arm_group_label>Caregivers who treat patients with venous leg ulcers (except nursing homes)</arm_group_label>
      <arm_group_label>Patients with / or had venous leg ulcers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Focus groups</intervention_name>
      <description>Identify facilities and difficulties in link with the prescription and implementation of the compression therapy everyday</description>
      <arm_group_label>Caregivers in nursing homes for dependant elderly people and institutions like hospital</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionary and measures</intervention_name>
      <description>To take measurement of patients who lives in institution or at their home and take measure of hydration and some other measures like the Group Iso Resource (GIR) and the capacity of the person to getting out of the bed.</description>
      <arm_group_label>Patients who are 60 years old and over</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          -  Group 1 : People who are 60 years old and older&#xD;
  &#xD;
            -  Group 2 : Patients who had or have venous leg ulcers&#xD;
  &#xD;
            -  Group 3 : Caregivers who work near and treat patients with venous leg ulcers&#xD;
  &#xD;
            -  Group 4 : Caregivers in nursing homes and institutions like hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Group 1 :&#xD;
  &#xD;
          Patients who are 60 years old and over Patients who have or not a compression therapy&#xD;
          Patients who have a social security system Patients who have received information of the&#xD;
          study and who approbate their participation&#xD;
  &#xD;
          - Group 2 et 3 : People who have or had venous leg ulcers People who use or have used&#xD;
          compression therapy People who can understand and exchange with the researcher People who&#xD;
          have received information of the study and who approbate their participation&#xD;
  &#xD;
          - Group 4 : Professionals who work in the investigated institution Professionals who have a&#xD;
          link with patients who have a compression therapy Professionals who have received&#xD;
          information of the study and who approbate their participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Group 1 :&#xD;
  &#xD;
          Patients who refused to participate at the study Patients who are under 60 years old.&#xD;
  &#xD;
          - Group 2 et 3 : People with cognitive disorders People who have no link with venous leg&#xD;
          ulcers People who have or had wounds except venous leg ulcers People who refused to&#xD;
          participate&#xD;
  &#xD;
          - Group 4 : Professionals who have no link with patients who have compression therapy&#xD;
          Profession who refused to participate&#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>Nathalie Barth, PHD</last_name>
      <role>Study Chair</role>
      <affiliation>Gerontopole Auvergne Rhone-Alpes (AURA)</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Gérontopole AURA</name>
        <address>
          <city>Saint-Étienne</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2021</verification_date>
    <study_first_submitted>August 5, 2021</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Compression; Vein</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982145
  org study id: GA-2021-04
  nct id: NCT05982145
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The compression therapy is a main treatment for chronic venous disease and its different
        phases. It has proven its effectiveness and usefulness in preventive phase and curative
        phase. Gérontopôle AURA leads with his partner Sigvaris a large study about the compression
        in institutions and at patient's homes. Indeed, through 3 studies, the mains goals are to
        identify the facilities and difficulties about the use of the actual tools. The final aim is
        to propose a future compression device wich could be adapted and that responds to the needs
        of users and the realities of the field. First study: Construction of a representative
        morphological database of people who are 60 years old and older. Indeed, the actually sizing
        tables are not specifics so not adapted to the morphology of the wearer. This can have an
        impact on the effectiveness of the treatment and the comfort of the patient. Second study:
        Have a deep comprehension about the pathway of the compression stockings and bandage in
        public and private establishment specifically retirements homes for dependant elderly people
        and hospital. The objectives are to understand and identify the role of health professionals
        from prescription to implementation to the compressive tools and have their feeds backs.
        Moreover, the goal is to collect the uses and constraints related to compression systems and
        to identify the possible improvements, needs and hindrances in link with compressions
        products. Third study: Study of acceptability of a new adjustable compression solution for
        venous ulcers. The main goal is to understand the needs and expectations by the users and to
        know if a new adjustable compression system could be accepted by them. For that, it's
        important to have a feed back about the use of the compression by the caregivers, medical
        staff and patients and evaluate the comfort about the use of the compression at patient's
        home and in institutions. Getting their advices, opinions are necessary too.
  The mains goals are to identify the facilities and difficulties about the use of the actual
        tools. The final aim is to propose a future compression device wich could be adapted and that
        responds to the needs of users and the realities of the field.
  observational model: Case-Only
  time perspective: Retrospective
  measure: data about leg's length
  time frame: Months 5
  description: Collect representative data about leg's length. Measure by questionary and taking measures
  measure: data about measure of hydration
  time frame: Months 5
  description: Collect representative data about measure of hydration. Measure by questionary and taking measures
  measure: data about the Group Iso Resource (GIR)
  time frame: Months 5
  description: Collect representative data about the Group Iso Resource (GIR). Measure by questionary and taking measures
  measure: data about the capacity of the person to getting out of the bed.
  time frame: Months 5
  description: Collect representative data about the capacity of the person to getting out of the bed. Measure by questionary and taking measures
  measure: caregivers's experiences and representations about compression systems of venous leg ulcer
  time frame: Months 6
  description: Measure by individuals interviews
  measure: patients' experiences and representations about compression systems of venous leg ulcer
  time frame: Months 6
  description: Measure by individuals interviews
  measure: caregivers's in institution experiences and representations about the pathway of compression systems in institution
  time frame: Months 18
  description: Measure by Focus Groups
  arm group label: Patients who are 60 years old and over
  description: Patients who are 60 years old and over had a questionary and a measure of their leg's length
  arm group label: Patients with / or had venous leg ulcers
  description: Patients with / or had venous leg ulcers actually have individual interviews
  arm group label: Caregivers who treat patients with venous leg ulcers (except nursing homes)
  description: Caregivers who treat patients with venous leg ulcers (except nursing homes) actually have individual interviews
  arm group label: Caregivers in nursing homes for dependant elderly people and institutions like hospital
  description: Caregivers in nursing homes for dependant elderly people and institutions like hospital actually have focus groups
  intervention type: Other
  intervention name: Individual interviews
  description: Identify the needs and expectations of the users about the compression therapy; Identify the possible facilities and difficulties in link with the management of the venous leg ulcers; Identify care experiences; Identify experiences about the actual compressions systems
  arm group label: Caregivers who treat patients with venous leg ulcers (except nursing homes)
  arm group label: Patients with / or had venous leg ulcers
  intervention type: Other
  intervention name: Focus groups
  description: Identify facilities and difficulties in link with the prescription and implementation of the compression therapy everyday
  arm group label: Caregivers in nursing homes for dependant elderly people and institutions like hospital
  intervention type: Other
  intervention name: Questionary and measures
  description: To take measurement of patients who lives in institution or at their home and take measure of hydration and some other measures like the Group Iso Resource (GIR) and the capacity of the person to getting out of the bed.
  arm group label: Patients who are 60 years old and over
  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: Nathalie Barth, PHD
  role: Study Chair
  affiliation: Gerontopole Auvergne Rhone-Alpes (AURA)
  facility: 
  country: France
  responsible party type: Sponsor