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| Name | Class |
|---|---|
| Bern University of Applied Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDPass Group | Experimental | Allocation of ONS in the MEDPass mode |
|
| Control Group | Active Comparator | Patients receive ONS between meals or at their request as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDPass mode of administration | Dietary Supplement | Allocation of 50 ml of ONS four times per day distributed with the medication rounds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average intake of energy / day (kcal, % of calculated daily requirement) | throughout the hospitalization: min. 3 to max. 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Average intake of protein /day (g, % of calculated daily requirement) | throughout the hospitalization: min. 3 to max. 30 days | |
| Average intake of ONS / day (ml) | throughout the hospitalisation: min. 3 to max. 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeno Stanga, Prof.Dr.med. | Insel Gruppe AG, University Hospital Bern | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Inselspital, Berne, Facility Tiefenau | Bern | Canton of Bern | 3004 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36525797 | Derived | Kurmann S, Reber E, Schonenberger KA, Schuetz P, Uhlmann K, Vasiloglou MF, Schoenenberger AW, Bertschi D, Sterchi AB, Stanga Z. MEDPass versus conventional administration of oral nutritional supplements - A randomized controlled trial comparing coverage of energy and protein requirements. Clin Nutr. 2023 Feb;42(2):108-115. doi: 10.1016/j.clnu.2022.11.015. Epub 2022 Dec 5. | |
| 33726841 |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized, controlled, open-label, clinical trial
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| Control Intervention | Dietary Supplement | Patients receive ONS between meals or at their request as usual |
|
| Development of hand grip strength (kg) | 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 JAMARĀ® 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 | throughout the hospitalisation: min. 3 to max. 30 days |
| Changes in body weight (kg) | 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. | throughout the hospitalisation: min. 3 to max. 30 days |
| Development of appetite visual analogue scale (VAS)-score (cm) | 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. | throughout the hospitalisation: min. 3 to max. 30 days |
| Development of nausea visual analogue scale (VAS)-score (cm) | 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. | throughout the hospitalisation: min. 3 to max. 30 days |
| Hospital length of stay (LOS) | hospitalization, max. 30 days |
| Mortality | 30 days |
| Derived |
| Kurmann S, Reber E, Vasiloglou MF, Schuetz P, Schoenenberger AW, Uhlmann K, Sterchi AB, Stanga Z. Energy and protein intake in medical and geriatric inpatients with MEDPass versus conventional administration of oral nutritional supplements: study protocol for the randomized controlled MEDPass Trial. Trials. 2021 Mar 16;22(1):210. doi: 10.1186/s13063-021-05145-4. |