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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

Tracking Information
First Submitted Date  ICMJE November 23, 2018
First Posted Date  ICMJE December 3, 2018
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE November 22, 2018
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
Average intake of energy / day (kcal, % of calculated daily requirement) [ Time Frame: throughout the hospitalization: min. 3 to max. 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
  • Average intake of protein /day (g, % of calculated daily requirement) [ Time Frame: throughout the hospitalization: min. 3 to max. 30 days ]
  • Average intake of ONS / day (ml) [ Time Frame: throughout the hospitalisation: min. 3 to max. 30 days ]
  • 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
  • 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.
  • 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.
  • 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.
  • Hospital length of stay (LOS) [ Time Frame: hospitalization, max. 30 days ]
  • Mortality [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MEDPass Trial: MedPass Versus Conventional Administration of Oral Nutritional Supplements
Official Title  ICMJE MEDPass Trial: MEDPass Versus Conventional Administration of Oral Nutritional Supplements: A RCT Comparing Energy and Protein Intake
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, controlled, open-label, clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malnutrition
Intervention  ICMJE
  • Dietary Supplement: MEDPass mode of administration
    Allocation of 50 ml of ONS four times per day distributed with the medication rounds
  • Dietary Supplement: Control Intervention
    Patients receive ONS between meals or at their request as usual
Study Arms  ICMJE
  • Experimental: MEDPass Group
    Allocation of ONS in the MEDPass mode
    Intervention: Dietary Supplement: MEDPass mode of administration
  • Active Comparator: Control Group
    Patients receive ONS between meals or at their request as usual
    Intervention: Dietary Supplement: Control Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03761680
Other Study ID Numbers  ICMJE 3804
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Bern University of Applied Sciences
Investigators  ICMJE
Study Chair: Zeno Stanga, Prof.Dr.med. University Hospital Inselspital, Berne
PRS Account University Hospital Inselspital, Berne
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP