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.
Malnutrition is a strong and independent long-term risk factor for mortality, rehospitalisation and functional decline, particularly in the elderly, polymorbid medical patient population. The randomized-controlled Effect of early nutritional support on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial (EFFORT, Lancet 2019) included 2028 patients in eight Swiss hospitals and found that nutritional support during the inhospital stay reduces very efficiently the risk for complications and mortality with numbers needed to treat (NNT) of 23 and 37, respectively. Yet, the nutritional intervention was not continued after hospital discharge of patients and long-term follow-up data of patients showed a lack of sustained effect of the initial nutritional support strategy. There is a current lack of trial data investigating whether long-term use of nutritional support has a sustained effect on clinical outcomes in this patient population. This study is to compare the continuous use of nutritional support with the use of approved oral nutritional supplements to reach protein and energy goals and to analyze whether medical patients at nutritional risk show a sustained benefit from long-term nutritional support after hospital discharge, and why and how nutritional support affects the course of disease from a mechanistic physio-pathological standpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,200
daily 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).
nutritional 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 information about health food behavior upon hospital discharge
Hospital Universitari Vall Hebron de Barcelona
Barcelona, Spain
RECRUITINGtime to death from any cause (i.e., all-cause mortality)
time to death from any cause (i.e., all-cause mortality)
Time frame: Enrollment to 3 years
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 frame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
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)
Time frame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
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)
Time frame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
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)
Time frame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
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Hospital Universitario de Getafe
Getafe, Spain
RECRUITINGComplejo AComplejo Asistencial Universitario de León
León, Spain
RECRUITINGHospital U. Gregorio Marañón de Madrid
Madrid, Spain
RECRUITINGHospital Universitario Regional de Málaga
Málaga, Spain
RECRUITINGHospital Clínico Universitario de Valladolid
Valladolid, Spain
RECRUITINGSpital Zofingen
Zofingen, Canton of Aargau, Switzerland
COMPLETEDSpital Emmental Burgdorf
Burgdorf, Canton of Bern, Switzerland
COMPLETEDSpital Thun
Thun, Canton of Bern, Switzerland
RECRUITINGSpital Lachen
Lachen, Canton of Schwyz, Switzerland
RECRUITING...and 8 more locations
Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS)
Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS) (scores range from 0 to 100, with higher scores indicating better health status).
Time frame: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]