Malnutrition
Conditions
Keywords
Nutritional Support, Oral Nutritional Supplements, Frailty, Mortality, Morbidity
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTnutritional supplement
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).
OTHERindividualized nutritional guidelines
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.
OTHERgeneral nutritional information
general information about health food behavior upon hospital discharge
Sponsors
Philipp Schuetz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This trial is single blinded (regarding outcome assessment)
Intervention model description
Pragmatic, single blinded, open label randomised-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 .
Exclusion criteria
* after surgery * unable to ingest oral nutrition * need for long-term nutrition, * terminal condition * acute pancreatitis or acute liver failure * patients discharged to a nursing home * patients unlikely to comply with nutritional support treatment (e.g., dementia) * COVID-Hospitalisation requiring intensive care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to death from any cause (i.e., all-cause mortality) | Enrollment to 3 years | time to death from any cause (i.e., all-cause mortality) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the first major complication | 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 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 to non-elective hospital readmission after discharge from the index hospital stay | assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)] | Time to non-elective hospital readmission after discharge from the index hospital stay |
| Changes in functional status measured by the Barthel's index | 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 (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) | 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 values range from 0 to 1, with higher scores indicating better quality of life) |
| Changes in quality of life measured with the visual-analogue scale (EQ-5D VAS) | 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 visual-analogue scale (EQ-5D VAS) (scores range from 0 to 100, with higher scores indicating better health status). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in bioelectrical impedance analysis (BIA) to assess body composition | assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits | 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 | assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits | Change in hand grip by means of handgrip strength through dynamometry (North Coast Medical Exacta™ Hydraulic Hand Dynamometer) to assess muscle strength |
| Change in calf circumference to assess muscle mass | assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits | Change in calf circumference to assess muscle mass |
| Change in body weight | assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits | Change in body weight |
Countries
Spain, Switzerland
Contacts
Primary ContactPhilipp Schuetz, Prof. Dr. med.
Outcome results
None listed