<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/NCT03240094</url>
  </required_header>
  <id_info>
    <org_study_id>NL53619.081.15</org_study_id>
    <nct_id>NCT03240094</nct_id>
  </id_info>
  <brief_title>Feasibility and Effectiveness of Nutritional Telemonitoring in Community-dwelling Elderly.</brief_title>
  <official_title>PhysioDom Home Dietary Intake Monitoring: Telemonitoring of Nutritional Parameters and Other Outcomes in Community Dwelling Elderly People: a Process and Effect Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Union</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Consorci Sanitari de Terrassa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Viveris Technologies SA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>STMicroelectronics Grenoble 2 SAS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sirlan Technologies SAS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Habitat Health Environment</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universite Paris 13</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Meditecnologia SA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cybermoor Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Telecom Sante</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zorggroep Noordwest-Veluwe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Opella</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wageningen University</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>
      An optimal nutritional status is essential for healthy ageing. Telemonitoring might&#xD;
      contribute to maintaining or improving nutritional status in elderly people.The objectives of&#xD;
      this effect study are to test the feasibility and effectiveness of telemonitoring of&#xD;
      nutritional parameters in community-dwelling older adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2016</start_date>
  <completion_date type="Actual">May 9, 2017</completion_date>
  <primary_completion_date type="Actual">May 9, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nutritional status (MNA)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by Mini Nutritional Assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioural determinant: Knowledge</measure>
    <time_frame>6 months</time_frame>
    <description>Measured with 11 knowledge statements to be answered by true/false/don't know</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural determinant: Goalsetting</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural determinant: Intention to eat healthy</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural determinant: Intention to improve physical activity</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural determinant: Self efficacy</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by two items to be answered on a 5 point likert scale on a 5-point likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural determinant: Perceived behavioural control</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by five items to be answered on a 5 point likert scale on a 5-point likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural determinants: Attitude</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by 14 items to be answered on a 5 point likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet quality (DHD-index)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by Dutch Healthy Diet index (DHD-index)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite (SNAQ)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by Simplified Nutritional Appetite Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight (kg)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by weighing scale of the brand A&amp;D, type UC-411PBT-C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning (SPPB)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by Short Physical Performance Battery (SPPB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional status (KATZ-15)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by KATZ-15</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-36)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by Short-Form 36</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Undernutrition</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Nutritional telemonitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention group receive a telemonitoring intervention, including self-measurements of body weight, nutritional status, appetite, diet quality, and physical activity. Additionally, participants receive guidance on nutrition and physical activity by means of customized and general television messages and/or if necessary personal guidance by a nurse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group receive usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional telemonitoring</intervention_name>
    <description>Participants receive a weighing scale, pedometer and television channel in order to perform self measurements and receive guidance on nutrition and physical activity. Nurses use a website in order to receive telemonitoring measurements and decide about proper follow-up. In case of risk of undernutrition, nurses provide personal advice to optimize nutritional status of the participant.</description>
    <arm_group_label>Nutritional telemonitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Having a care referral for at least one of the following types of care:&#xD;
&#xD;
          -  Domestic care&#xD;
&#xD;
          -  Personal care&#xD;
&#xD;
          -  Nursing care&#xD;
&#xD;
          -  Individual or group support&#xD;
&#xD;
          -  Living in a sheltered home or service flat&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment (Mini Mental State Examination (MMSE) &lt; 20)&#xD;
&#xD;
          -  Receiving terminal care&#xD;
&#xD;
          -  Not having a television at home&#xD;
&#xD;
          -  Clients with a visual impairment (not able to watch the television screen)&#xD;
&#xD;
          -  Clients with a physical impairment in such a way, that they are not able to use the&#xD;
             telemonitoring system&#xD;
&#xD;
          -  Clients with nursing home care&#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>Lisette de Groot, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Wageningen University &amp; Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marije van Doorn, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen University &amp; Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeanne de Vries, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen University &amp; Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Annemien Haveman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen University &amp; Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wageningen University &amp; Research</name>
      <address>
        <city>Wageningen</city>
        <zip>6700AA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ehealth</keyword>
  <keyword>Older adults</keyword>
  <keyword>Undernutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03240094
org study id: NL53619.081.15
nct id: NCT03240094
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An optimal nutritional status is essential for healthy ageing. Telemonitoring might
      contribute to maintaining or improving nutritional status in elderly people.The objectives of
      this effect study are to test the feasibility and effectiveness of telemonitoring of
      nutritional parameters in community-dwelling older adults.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Nutritional status (MNA)
time frame: 6 months
description: Measured by Mini Nutritional Assessment
measure: Behavioural determinant: Knowledge
time frame: 6 months
description: Measured with 11 knowledge statements to be answered by true/false/don't know
measure: Behavioural determinant: Goalsetting
time frame: 6 months
description: Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
measure: Behavioural determinant: Intention to eat healthy
time frame: 6 months
description: Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
measure: Behavioural determinant: Intention to improve physical activity
time frame: 6 months
description: Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.
measure: Behavioural determinant: Self efficacy
time frame: 6 months
description: Measured by two items to be answered on a 5 point likert scale on a 5-point likert scale.
measure: Behavioural determinant: Perceived behavioural control
time frame: 6 months
description: Measured by five items to be answered on a 5 point likert scale on a 5-point likert scale.
measure: Behavioural determinants: Attitude
time frame: 6 months
description: Measured by 14 items to be answered on a 5 point likert scale
measure: Diet quality (DHD-index)
time frame: 6 months
description: Measured by Dutch Healthy Diet index (DHD-index)
measure: Appetite (SNAQ)
time frame: 6 months
description: Measured by Simplified Nutritional Appetite Questionnaire
measure: Body weight (kg)
time frame: 6 months
description: Measured by weighing scale of the brand A&D, type UC-411PBT-C
measure: Physical functioning (SPPB)
time frame: 6 months
description: Measured by Short Physical Performance Battery (SPPB)
measure: Functional status (KATZ-15)
time frame: 6 months
description: Measured by KATZ-15
measure: Quality of life (SF-36)
time frame: 6 months
description: Measured by Short-Form 36
arm group label: Nutritional telemonitoring
arm group type: Experimental
description: Participants in the intervention group receive a telemonitoring intervention, including self-measurements of body weight, nutritional status, appetite, diet quality, and physical activity. Additionally, participants receive guidance on nutrition and physical activity by means of customized and general television messages and/or if necessary personal guidance by a nurse.
arm group label: Usual care
arm group type: No Intervention
description: Participants in the control group receive usual care.
intervention type: Other
intervention name: Nutritional telemonitoring
description: Participants receive a weighing scale, pedometer and television channel in order to perform self measurements and receive guidance on nutrition and physical activity. Nurses use a website in order to receive telemonitoring measurements and decide about proper follow-up. In case of risk of undernutrition, nurses provide personal advice to optimize nutritional status of the participant.
arm group label: Nutritional telemonitoring
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Lisette de Groot, Professor
role: Study Chair
affiliation: Wageningen University & Research
last name: Marije van Doorn, MSc
role: Principal Investigator
affiliation: Wageningen University & Research
last name: Jeanne de Vries, PhD
role: Principal Investigator
affiliation: Wageningen University & Research
last name: Annemien Haveman, PhD
role: Principal Investigator
affiliation: Wageningen University & Research
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: Undecided