<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/NCT02196428</url>
  </required_header>
  <id_info>
    <org_study_id>USZ 14809.2</org_study_id>
    <nct_id>NCT02196428</nct_id>
  </id_info>
  <brief_title>Medical Telemonitoring Plus Individual Teleconsultation in Elderly</brief_title>
  <official_title>Medical Telemonitoring Plus Individual Teleconsultation Based on an Ambient Assisted Living (AAL-) Wizard - an Interdisciplinary, Integrated Innovation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to explore the requirements and conditions of medical&#xD;
      teleconsultation and remote diagnostics (telemonitoring) of older people in the residential&#xD;
      environment with an emphasis on the need for adaptation, feasibility and acceptance of&#xD;
      telemedicine services to a web based documentation and communication platform (Ambient&#xD;
      Assisted Living Wizard).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The technical development of the so-called &quot;AAL Wizard&quot; is basis for the study. The&#xD;
      AAL-Wizard is an IHE(Integrating the Healthcare Enterprise)-compliant, web based&#xD;
      documentation and communication platform with an integrated electronic patient record, which&#xD;
      can be used by the study participants during the study. Vital parameters are collected with&#xD;
      the help of certified medical products according to the guidelines &quot;93/42/EEC(European&#xD;
      Economic Community) on medical devices&quot; (e.g. blood pressure devices, scales, pedometers),&#xD;
      transmitted electronically, documented and archived directly in the system. Vital parameters&#xD;
      out of range will be prioritized displayed in the AAL Wizard (e.g. traffic light system,&#xD;
      short message notification, pop-up function, etc.) and the study participant will be&#xD;
      contacted by the tele doctor (teleconsultation) . The decision on the necessary intervention&#xD;
      (e.g. contact of the in-house home care, therapeutic and diagnostic recommendations or&#xD;
      recommendation of a primary care consultation /hospital submission) are in the responsibility&#xD;
      of the tele doctor based on the communication with the patient and the family doctor's&#xD;
      recommendations for the treatment of his patient.&#xD;
&#xD;
      At the beginning of the study, the tele doctors of the Clinical Telemedicine at the&#xD;
      University Hospital Zurich (USZ) perform an appointment with the respective study&#xD;
      participants. The electronic patient record will be set up and the process of the&#xD;
      telemonitoring will be defined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>User profile of medical telemonitoring and teleconsultation</measure>
    <time_frame>10 months</time_frame>
    <description>Objective criteria:&#xD;
Age, sex, weight, height, education, civil status, diagnosis, medical history, medication, alcohol and tabacco consumption using interval, nominal and ordinal scales.&#xD;
Subjective criteria:&#xD;
Subjective state of health : German questionnaire Short Form (SF)-36/SF-12&#xD;
Integration into social networks and assessment of social support, self-management skills: 10-item questionnaire using 5-point Likert scale responses do not apply at all (1) to apply (5).&#xD;
Health literacy: 13-item questionnaire using 4-point Likert scale responses do not apply (1) to apply (4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Demand of health information</measure>
    <time_frame>10 months</time_frame>
    <description>Text analysis with inductive category developement of teleconsultation services via telephone, video and online consultation and telemonitoring</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptance medical telemonitoring and teleconsultation</measure>
    <time_frame>10 months</time_frame>
    <description>Observed acceptance in relation to the intervention&#xD;
compliance using inducive category development&#xD;
quality of service : 3-item questionnaire using 5-point Likert scale responses do not apply at all (1) to apply (5)&#xD;
Acceptance of user using inducive category development</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptance and demand of health information of secondary end users of telemedical services</measure>
    <time_frame>10 months</time_frame>
    <description>Acceptance and demand of health information of telemedical service of secondary end users (family practitioner, other caregivers, family) using text analysis with inductive category developement and open structured, inductive questionnaires.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Telemedicine</condition>
  <arm_group>
    <arm_group_label>Telemonitoring and Teleconsultation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemonitoring and Teleconsultation</intervention_name>
    <description>The interventions of this study are supported by a so-called Ambient Assisted Living Wizard (AAL Wizard). This is an IHE-compliant documentation and communication platform with an integrated electronic health record, which enables the study participants (elderly) to manage and store their relevant health data. It includes personal master data and the documentation of telemonitoring data. Additionally, the AAL-Wizard provides the communication modules such as telephone -, video- and time- and online consultation. The tele doctor assess the data (eg, vital signs and content of the medical teleconsultation) and collaborates in this way with the older person, family physicians and other health care providers based on an innovative and flexible telemedical home care service.</description>
    <arm_group_label>Telemonitoring and Teleconsultation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  german speaking&#xD;
&#xD;
          -  voluntary participation&#xD;
&#xD;
          -  written consent of the trial participant after enlightenment&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  apply to health conditions (physical and / or psychological) when verbal communication&#xD;
             and / or the operation of the AAL Wizard and an independent living in their own living&#xD;
             area is not possible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christiane Brockes, MD, PD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Rämistrasse 100, 8091 Zurich, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Telemedicine, University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>December 3, 2015</last_update_submitted>
  <last_update_submitted_qc>December 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ambient Assisted Living (AAL)</keyword>
  <keyword>Telemonitoring</keyword>
  <keyword>Teleconsultation</keyword>
  <!-- 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/NCT02196428
org study id: USZ 14809.2
nct id: NCT02196428
lead sponsor: 
has dmc: No
The aim of this study is to explore the requirements and conditions of medical
      teleconsultation and remote diagnostics (telemonitoring) of older people in the residential
      environment with an emphasis on the need for adaptation, feasibility and acceptance of
      telemedicine services to a web based documentation and communication platform (Ambient
      Assisted Living Wizard).
The technical development of the so-called "AAL Wizard" is basis for the study. The
      AAL-Wizard is an IHE(Integrating the Healthcare Enterprise)-compliant, web based
      documentation and communication platform with an integrated electronic patient record, which
      can be used by the study participants during the study. Vital parameters are collected with
      the help of certified medical products according to the guidelines "93/42/EEC(European
      Economic Community) on medical devices" (e.g. blood pressure devices, scales, pedometers),
      transmitted electronically, documented and archived directly in the system. Vital parameters
      out of range will be prioritized displayed in the AAL Wizard (e.g. traffic light system,
      short message notification, pop-up function, etc.) and the study participant will be
      contacted by the tele doctor (teleconsultation) . The decision on the necessary intervention
      (e.g. contact of the in-house home care, therapeutic and diagnostic recommendations or
      recommendation of a primary care consultation /hospital submission) are in the responsibility
      of the tele doctor based on the communication with the patient and the family doctor's
      recommendations for the treatment of his patient.

      At the beginning of the study, the tele doctors of the Clinical Telemedicine at the
      University Hospital Zurich (USZ) perform an appointment with the respective study
      participants. The electronic patient record will be set up and the process of the
      telemonitoring will be defined.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: User profile of medical telemonitoring and teleconsultation
time frame: 10 months
description: Objective criteria:
Age, sex, weight, height, education, civil status, diagnosis, medical history, medication, alcohol and tabacco consumption using interval, nominal and ordinal scales.
Subjective criteria:
Subjective state of health : German questionnaire Short Form (SF)-36/SF-12
Integration into social networks and assessment of social support, self-management skills: 10-item questionnaire using 5-point Likert scale responses do not apply at all (1) to apply (5).
Health literacy: 13-item questionnaire using 4-point Likert scale responses do not apply (1) to apply (4).
measure: Demand of health information
time frame: 10 months
description: Text analysis with inductive category developement of teleconsultation services via telephone, video and online consultation and telemonitoring
measure: Acceptance medical telemonitoring and teleconsultation
time frame: 10 months
description: Observed acceptance in relation to the intervention
compliance using inducive category development
quality of service : 3-item questionnaire using 5-point Likert scale responses do not apply at all (1) to apply (5)
Acceptance of user using inducive category development
measure: Acceptance and demand of health information of secondary end users of telemedical services
time frame: 10 months
description: Acceptance and demand of health information of telemedical service of secondary end users (family practitioner, other caregivers, family) using text analysis with inductive category developement and open structured, inductive questionnaires.
arm group label: Telemonitoring and Teleconsultation
arm group type: Other
intervention type: Other
intervention name: Telemonitoring and Teleconsultation
description: The interventions of this study are supported by a so-called Ambient Assisted Living Wizard (AAL Wizard). This is an IHE-compliant documentation and communication platform with an integrated electronic health record, which enables the study participants (elderly) to manage and store their relevant health data. It includes personal master data and the documentation of telemonitoring data. Additionally, the AAL-Wizard provides the communication modules such as telephone -, video- and time- and online consultation. The tele doctor assess the data (eg, vital signs and content of the medical teleconsultation) and collaborates in this way with the older person, family physicians and other health care providers based on an innovative and flexible telemedical home care service.
arm group label: Telemonitoring and Teleconsultation
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Christiane Brockes, MD, PD
role: Principal Investigator
affiliation: University Hospital Zurich, Rämistrasse 100, 8091 Zurich, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor