<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/NCT03761680</url>
  </required_header>
  <id_info>
    <org_study_id>3804</org_study_id>
    <nct_id>NCT03761680</nct_id>
  </id_info>
  <brief_title>MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements</brief_title>
  <official_title>MEDPass Trial: MEDPass Versus Conventional Administration of Oral Nutritional Supplements: A RCT Comparing Energy and Protein Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bern University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</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 aim of the randomized-controlled, single-center MEDPass trial is to assess the effects of&#xD;
      MEDPass versus conventional administration of oral nutritional supplements (ONS) on energy&#xD;
      and protein intake in medical and geriatric inpatients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Disease related malnutrition (DRM) in hospitalized patients is a common problem.The oral&#xD;
      nutritional support with ONS is one of the first and most common treatment approach in the&#xD;
      patients at nutritional risk. Treatment with ONS may reduce mortality and complications in&#xD;
      hospitalized patients.&#xD;
&#xD;
      There are no standards on the type of administration of ONS in terms of timing throughout the&#xD;
      day leading to individual approaches. ONS are conventionally served as snacks by nurses,&#xD;
      nursing aids or gastronomy personnel between the main meals. The MEDPass-mode offers a&#xD;
      different approach by serving ONS together with the medication, three or four times per day,&#xD;
      in unusually small portions. Preliminary trials suggest that compliance and cost&#xD;
      effectiveness may be improved with the MEDPass-mode.&#xD;
&#xD;
      Enhancing compliance to ONS may not consequently lead to improved total energy and protein&#xD;
      intake throughout the day. There has never been a large trial in which total energy- and&#xD;
      protein intake of the subjects was studied consequently and systematically throughout the&#xD;
      hospitalization. Therefore, this trial will bridge this gap by studying total energy- and&#xD;
      protein intake as primary outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</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>
    <intervention_model_description>Randomized, controlled, open-label, clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average intake of energy / day (kcal, % of calculated daily requirement)</measure>
    <time_frame>throughout the hospitalization: min. 3 to max. 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average intake of protein /day (g, % of calculated daily requirement)</measure>
    <time_frame>throughout the hospitalization: min. 3 to max. 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average intake of ONS / day (ml)</measure>
    <time_frame>throughout the hospitalisation: min. 3 to max. 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of hand grip strength (kg)</measure>
    <time_frame>throughout the hospitalisation: min. 3 to max. 30 days</time_frame>
    <description>Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past.&#xD;
Evaluated with the JAMAR® Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA).&#xD;
If possible, measurements are conducted on the dominant hand, three times with a break of at least 30 seconds between the measurements.&#xD;
The highest value is noted. Accuracy: 0.5 kg. Range: 0.0 - 90.0 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight (kg)</measure>
    <time_frame>throughout the hospitalisation: min. 3 to max. 30 days</time_frame>
    <description>Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past.&#xD;
Accuracy: 0.1 kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of appetite visual analogue scale (VAS)-score (cm)</measure>
    <time_frame>throughout the hospitalisation: min. 3 to max. 30 days</time_frame>
    <description>Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past.&#xD;
The present day is the focus of the assessment. On the front of the scale which is visible to the patient, only smileys are shown.&#xD;
The scale on the back ranges from 0-10 cm to objectify the measurement with 10 cm being the most desirable.&#xD;
Accuracy:0.1 cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of nausea visual analogue scale (VAS)-score (cm)</measure>
    <time_frame>throughout the hospitalisation: min. 3 to max. 30 days</time_frame>
    <description>Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past.&#xD;
The present day is the focus of the assessment. On the front of the scale which is visible to the patient, only smileys are shown.&#xD;
The scale on the back ranges from 0-10 cm to objectify the measurement with 10 cm being the most desirable.&#xD;
Accuracy: 0.1 cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay (LOS)</measure>
    <time_frame>hospitalization, max. 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>MEDPass Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Allocation of ONS in the MEDPass mode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive ONS between meals or at their request as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>MEDPass mode of administration</intervention_name>
    <description>Allocation of 50 ml of ONS four times per day distributed with the medication rounds</description>
    <arm_group_label>MEDPass Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control Intervention</intervention_name>
    <description>Patients receive ONS between meals or at their request as usual</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nutritional risk screening (NRS-2002) total score ≥3 points according to routine&#xD;
             screening at admission within 72 hours&#xD;
&#xD;
          -  Expected hospital LOS ≥3 days after screening (as estimated by the treating physician)&#xD;
&#xD;
          -  Patient qualifies for ONS and approves prescription&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Willingness and ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Initially admitted to critical care unit&#xD;
&#xD;
          -  Immediate post-operative phase (&lt;7 days post-surgery)&#xD;
&#xD;
          -  Dysphagia with the inability to swallow liquids&#xD;
&#xD;
          -  Supplemental enteral and/or parenteral nutrition&#xD;
&#xD;
          -  Admitted with, or scheduled for, total parenteral nutrition or tube feeding&#xD;
&#xD;
          -  Mini Mental State examination &lt; 16 points&#xD;
&#xD;
          -  hospitalized due to anorexia nervosa&#xD;
&#xD;
          -  hospitalized due to acute pancreatitis&#xD;
&#xD;
          -  hospitalized due to acute liver failure&#xD;
&#xD;
          -  cystic fibrosis&#xD;
&#xD;
          -  patients after gastric bypass surgery&#xD;
&#xD;
          -  patients with short bowel syndrome&#xD;
&#xD;
          -  terminal condition (end of life situation)&#xD;
&#xD;
          -  poor skills in German language (study language)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zeno Stanga, Prof.Dr.med.</last_name>
    <role>Study Chair</role>
    <affiliation>Insel Gruppe AG, University Hospital Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Inselspital, Berne, Facility Tiefenau</name>
      <address>
        <city>Bern</city>
        <state>BE</state>
        <zip>3004</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malnutrition</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>No</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/NCT03761680
org study id: 3804
nct id: NCT03761680
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the randomized-controlled, single-center MEDPass trial is to assess the effects of
      MEDPass versus conventional administration of oral nutritional supplements (ONS) on energy
      and protein intake in medical and geriatric inpatients.
Disease related malnutrition (DRM) in hospitalized patients is a common problem.The oral
      nutritional support with ONS is one of the first and most common treatment approach in the
      patients at nutritional risk. Treatment with ONS may reduce mortality and complications in
      hospitalized patients.

      There are no standards on the type of administration of ONS in terms of timing throughout the
      day leading to individual approaches. ONS are conventionally served as snacks by nurses,
      nursing aids or gastronomy personnel between the main meals. The MEDPass-mode offers a
      different approach by serving ONS together with the medication, three or four times per day,
      in unusually small portions. Preliminary trials suggest that compliance and cost
      effectiveness may be improved with the MEDPass-mode.

      Enhancing compliance to ONS may not consequently lead to improved total energy and protein
      intake throughout the day. There has never been a large trial in which total energy- and
      protein intake of the subjects was studied consequently and systematically throughout the
      hospitalization. Therefore, this trial will bridge this gap by studying total energy- and
      protein intake as primary outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, controlled, open-label, clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Average intake of energy / day (kcal, % of calculated daily requirement)
time frame: throughout the hospitalization: min. 3 to max. 30 days
measure: Average intake of protein /day (g, % of calculated daily requirement)
time frame: throughout the hospitalization: min. 3 to max. 30 days
measure: Average intake of ONS / day (ml)
time frame: throughout the hospitalisation: min. 3 to max. 30 days
measure: Development of hand grip strength (kg)
time frame: throughout the hospitalisation: min. 3 to max. 30 days
description: Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past.
Evaluated with the JAMAR® Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA).
If possible, measurements are conducted on the dominant hand, three times with a break of at least 30 seconds between the measurements.
The highest value is noted. Accuracy: 0.5 kg. Range: 0.0 - 90.0 kg
measure: Changes in body weight (kg)
time frame: throughout the hospitalisation: min. 3 to max. 30 days
description: Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past.
Accuracy: 0.1 kg.
measure: Development of appetite visual analogue scale (VAS)-score (cm)
time frame: throughout the hospitalisation: min. 3 to max. 30 days
description: Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past.
The present day is the focus of the assessment. On the front of the scale which is visible to the patient, only smileys are shown.
The scale on the back ranges from 0-10 cm to objectify the measurement with 10 cm being the most desirable.
Accuracy:0.1 cm.
measure: Development of nausea visual analogue scale (VAS)-score (cm)
time frame: throughout the hospitalisation: min. 3 to max. 30 days
description: Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past.
The present day is the focus of the assessment. On the front of the scale which is visible to the patient, only smileys are shown.
The scale on the back ranges from 0-10 cm to objectify the measurement with 10 cm being the most desirable.
Accuracy: 0.1 cm.
measure: Hospital length of stay (LOS)
time frame: hospitalization, max. 30 days
measure: Mortality
time frame: 30 days
arm group label: MEDPass Group
arm group type: Experimental
description: Allocation of ONS in the MEDPass mode
arm group label: Control Group
arm group type: Active Comparator
description: Patients receive ONS between meals or at their request as usual
intervention type: Dietary Supplement
intervention name: MEDPass mode of administration
description: Allocation of 50 ml of ONS four times per day distributed with the medication rounds
arm group label: MEDPass Group
intervention type: Dietary Supplement
intervention name: Control Intervention
description: Patients receive ONS between meals or at their request as usual
arm group label: Control Group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Zeno Stanga, Prof.Dr.med.
role: Study Chair
affiliation: Insel Gruppe AG, University Hospital Bern
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No