About this trial
This study is to compare the sustained post-discharge nutritional support to reach individual energy and protein goals to usual care home nutrition in medical patients at nutritional risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed Consent as documented by signature
Adult (age ≥18 years), medical patients
Nutritional risk screening using the Nutritional Risk Screening (NRS): total score ≥3 points consisting of ≥1 points for impairment of the nutritional status [weight loss >5% in 3 month or food intake of 50-75% in the last week before hospital admission] plus ≥1 for the severity of the disease (i.e., cancer, chronic kidney disease, chronic heart failure, COPD) and other chronic diseases according to the definition of the "National Center for Chronic Disease Prevention and Health Promotion": Chronic diseases are defined broadly as conditions that last 1 year or more and require ongoing medical attention or limit activities of daily living or both .
Disqualifiers
after surgery
unable to ingest oral nutrition
need for long-term nutrition,
terminal condition
Trial design
Parallel
Treatments tested in this trial
nutritional supplement
Dietary supplementdaily use of one or more specific oral nutritional supplement with high energy/protein content (i.e., Resource Ultra, Resource 2.0 (Fibre), Resource Ultra Fruit).
individualized nutritional guidelines
Other interventionnutritional plan supervised by an experienced study dietician based on the usual home nutrition with possibility to increase intake by adaptation to patient preferences, between meal snaking and food enrichment/fortification. Every 2-4 weeks phone call by unblinded study dietician to follow nutritional intervention.
general nutritional information
Other interventiongeneral information about health food behavior upon hospital discharge
Treatment groups
Trial outcomes
Primary outcomes
time to death from any cause (i.e., all-cause mortality)
time to death from any cause (i.e., all-cause mortality)
Secondary outcomes
Time to non-elective hospital readmission after discharge from the index hospital stay
Time to non-elective hospital readmission after discharge from the index hospital stay
Time to the first major complication
time to the first major complication including death, bacterial infection with need for antibiotic treatment, major cardiovascular event (i.e., stroke, intracranial bleeding, cardiac arrest, myocardial infarction) or pulmonary embolism, acute renal failure, gastro-intestinal events (including hemorrhage, intestinal perforation, acute pancreatitis)
Changes in functional status measured by the Barthel's index
Changes in functional status measured by the Barthel's index (scores range from 0 to 100, with higher scores indicating better functional status)
Changes in quality of life measured with the European Quality of Life 5 Dimensions index (German Version, EQ-5D index)
Changes in quality of life measured with the European Quality of Life 5 Dimensions index (German Version, EQ-5D index values range from 0 to 1, with higher scores indicating better quality of life)
Other outcomes
Change in body weight
Change in body weight
Change in calf circumference to assess muscle mass
Change in calf circumference to assess muscle mass
Change in bioelectrical impedance analysis (BIA) to assess body composition
Change in bioelectrical impedance analysis (BIA) to assess body composition
Change in hand grip by means of handgrip strength through dynamometry (North Coast Medical Exacta™ Hydraulic Hand Dynamometer) to assess muscle strength
Change in hand grip by means of handgrip strength through dynamometry (North Coast Medical Exacta™ Hydraulic Hand Dynamometer) to assess muscle strength
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Philipp Schuetz
Lead sponsor
Kantonsspital Aarau
Sponsor institution