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

Last updated: November 18, 2024
Sponsor: Philipp Schuetz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Diet And Nutrition

Treatment

individualized nutritional guidelines

nutritional supplement

general nutritional information

Clinical Study ID

NCT04926597
2021-00278; ex20Schuetz
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 [weightloss >5% in 3 month or food intake of 50-75% in the last week before hospitaladmission] plus ≥1 for the severity of the disease (i.e., cancer, chronic kidneydisease, chronic heart failure, COPD) and other chronic diseases according to thedefinition of the "National Center for Chronic Disease Prevention and HealthPromotion": Chronic diseases are defined broadly as conditions that last 1 year ormore and require ongoing medical attention or limit activities of daily living orboth .

Exclusion

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

Study Design

Total Participants: 1200
Treatment Group(s): 3
Primary Treatment: individualized nutritional guidelines
Phase:
Study Start date:
August 05, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Hospital Universitari Vall Hebron de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario de Getafe

    Getafe,
    Spain

    Active - Recruiting

  • Complejo AComplejo Asistencial Universitario de León

    León,
    Spain

    Active - Recruiting

  • Hospital U. Gregorio Marañón de Madrid

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Regional de Málaga

    Málaga,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • Spital Zofingen

    Zofingen, Aargau 4800
    Switzerland

    Completed

  • Spital Emmental Burgdorf

    Burgdorf, Bern 3400
    Switzerland

    Completed

  • Spital Thun

    Thun, Bern 3600
    Switzerland

    Active - Recruiting

  • Spital Lachen

    Lachen, Schwyz 8853
    Switzerland

    Active - Recruiting

  • Kantonsspital Münsterlingen

    Münsterlingen, Thurgau 8596
    Switzerland

    Active - Recruiting

  • Kantonsspital Aarau, University Department of Internal Medicine

    Aarau, 5001
    Switzerland

    Active - Recruiting

  • Bern University Hospital, Department of General Internal Medicine

    Bern,
    Switzerland

    Completed

  • Kantonsspital Lucerne, Department of Internal Medicine

    Lucerne,
    Switzerland

    Completed

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007
    Switzerland

    Completed

  • Klinik Hirslanden Zürich

    Zürich, 8032
    Switzerland

    Completed

  • Stadtspital Zürich

    Zürich, 8063
    Switzerland

    Completed

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Completed

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