RecruitingNot ApplicableNCT04926597

Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery

Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery Trial: The EFFORT II Project


Sponsor

Philipp Schuetz

Enrollment

1,200 participants

Start Date

Aug 5, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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

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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


Locations(18)

Hospital Universitari Vall Hebron de Barcelona

Barcelona, Spain

Hospital Universitario de Getafe

Getafe, Spain

Complejo AComplejo Asistencial Universitario de León

León, Spain

Hospital U. Gregorio Marañón de Madrid

Madrid, Spain

Hospital Universitario Regional de Málaga

Málaga, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Spital Zofingen

Zofingen, Canton of Aargau, Switzerland

Spital Emmental Burgdorf

Burgdorf, Canton of Bern, Switzerland

Spital Thun

Thun, Canton of Bern, Switzerland

Spital Lachen

Lachen, Canton of Schwyz, Switzerland

Kantonsspital Münsterlingen

Münsterlingen, Thurgau, Switzerland

Kantonsspital Aarau, University Department of Internal Medicine

Aarau, Switzerland

Bern University Hospital, Department of General Internal Medicine

Bern, Switzerland

Kantonsspital Lucerne, Department of Internal Medicine

Lucerne, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

Klinik Hirslanden Zürich

Zurich, Switzerland

Stadtspital Zürich

Zurich, Switzerland

Universitätsspital Zürich

Zurich, Switzerland

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NCT04926597


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