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MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements

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ClinicalTrials.gov Identifier: NCT03761680
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 23, 2019
Sponsor:
Collaborator:
Bern University of Applied Sciences
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: MEDPass mode of administration Dietary Supplement: Control Intervention Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, open-label, clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MEDPass Trial: MEDPass Versus Conventional Administration of Oral Nutritional Supplements: A RCT Comparing Energy and Protein Intake
Actual Study Start Date : November 22, 2018
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MEDPass Group
Allocation of ONS in the MEDPass mode
Dietary Supplement: MEDPass mode of administration
Allocation of 50 ml of ONS four times per day distributed with the medication rounds

Active Comparator: Control Group
Patients receive ONS between meals or at their request as usual
Dietary Supplement: Control Intervention
Patients receive ONS between meals or at their request as usual




Primary Outcome Measures :
  1. Average intake of energy / day (kcal, % of calculated daily requirement) [ Time Frame: throughout the hospitalization: min. 3 to max. 30 days ]

Secondary Outcome Measures :
  1. Average intake of protein /day (g, % of calculated daily requirement) [ Time Frame: throughout the hospitalization: min. 3 to max. 30 days ]
  2. Average intake of ONS / day (ml) [ Time Frame: throughout the hospitalisation: min. 3 to max. 30 days ]
  3. Development of hand grip strength (kg) [ Time Frame: throughout the hospitalisation: min. 3 to max. 30 days ]

    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


  4. Changes in body weight (kg) [ Time Frame: throughout the hospitalisation: min. 3 to max. 30 days ]

    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.


  5. Development of appetite visual analogue scale (VAS)-score (cm) [ Time Frame: throughout the hospitalisation: min. 3 to max. 30 days ]

    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.


  6. Development of nausea visual analogue scale (VAS)-score (cm) [ Time Frame: throughout the hospitalisation: min. 3 to max. 30 days ]

    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.


  7. Hospital length of stay (LOS) [ Time Frame: hospitalization, max. 30 days ]
  8. Mortality [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nutritional risk screening (NRS-2002) total score ≥3 points according to routine screening at admission within 72 hours
  • Expected hospital LOS ≥3 days after screening (as estimated by the treating physician)
  • Patient qualifies for ONS and approves prescription
  • Age >18 years
  • Willingness and ability to provide informed consent

Exclusion Criteria:

  • Initially admitted to critical care unit
  • Immediate post-operative phase (<7 days post-surgery)
  • Dysphagia with the inability to swallow liquids
  • Supplemental enteral and/or parenteral nutrition
  • Admitted with, or scheduled for, total parenteral nutrition or tube feeding
  • Mini Mental State examination < 16 points
  • hospitalized due to anorexia nervosa
  • hospitalized due to acute pancreatitis
  • hospitalized due to acute liver failure
  • cystic fibrosis
  • patients after gastric bypass surgery
  • patients with short bowel syndrome
  • terminal condition (end of life situation)
  • poor skills in German language (study language)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761680


Contacts
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Contact: Zeno Stanga, Prof.Dr.med. +41 31 632 42 46 zeno.stanga@insel.ch
Contact: Andreas Schönenberger, Prof.Dr.med. +41 31 308 83 65 andreas.schoenenberger@spitaltiefenau.ch

Locations
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Switzerland
University Hospital Inselspital, Berne, Facility Tiefenau Recruiting
Bern, BE, Switzerland, 3004
Sponsors and Collaborators
University Hospital Inselspital, Berne
Bern University of Applied Sciences
Investigators
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Study Chair: Zeno Stanga, Prof.Dr.med. University Hospital Inselspital, Berne
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03761680    
Other Study ID Numbers: 3804
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Malnutrition
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders