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

November 18, 2024 updated by: Philipp Schuetz

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
  • Switzerland
      • Aarau, Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau, University Department of Internal Medicine
        • Contact:
        • Principal Investigator:
          • Philipp Schuetz, Prof. Dr. med.
        • Sub-Investigator:
          • Beat Mueller, Prof. Dr. med
        • Sub-Investigator:
          • Nina Kägi-Braun, Dr. med.
        • Sub-Investigator:
          • Manuela Deiss
        • Sub-Investigator:
          • T Ehmann, Dr. med.
        • Sub-Investigator:
          • Pascal Tribolet
        • Sub-Investigator:
          • Carla Wunderle, PhD
      • Bern, Switzerland
        • Completed
        • Bern University Hospital, Department of General Internal Medicine
      • Lucerne, Switzerland
        • Completed
        • Kantonsspital Lucerne, Department of Internal Medicine
      • Sankt Gallen, Switzerland, 9007
        • Completed
        • Kantonsspital Sankt Gallen
      • Zürich, Switzerland, 8091
        • Completed
        • Universitatsspital Zurich
      • Zürich, Switzerland, 8032
        • Completed
        • Klinik Hirslanden Zürich
      • Zürich, Switzerland, 8063
        • Completed
        • Stadtspital Zürich
    • Aargau
      • Zofingen, Aargau, Switzerland, 4800
        • Completed
        • Spital Zofingen
    • Bern
      • Burgdorf, Bern, Switzerland, 3400
        • Completed
        • Spital Emmental Burgdorf
      • Thun, Bern, Switzerland, 3600
        • Recruiting
        • Spital Thun
        • Contact:
        • Principal Investigator:
          • Thomas Zehnder, Dr. med.
    • Schwyz
      • Lachen, Schwyz, Switzerland, 8853
        • Recruiting
        • Spital Lachen
        • Contact:
        • Principal Investigator:
          • Thomas Bregenzer, Dr. med.
    • Thurgau
      • Münsterlingen, Thurgau, Switzerland, 8596
        • Recruiting
        • Kantonsspital Münsterlingen
        • Contact:
          • Vojtech Pavlicek, Dr. med.
        • Principal Investigator:
          • Vojtech Pavlicek, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group: individualized nutritional support
Intervention group patients will receive individualized nutritional support to reach energy and protein goals with the support of an experienced, unblinded dietician and with use of oral nutritional supplements (ONS) as needed
Dietary supplement: nutritional 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).
Other: individualized 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.
Other: Control group: general information on healthy food habits
Control group patients will receive nutritional counselling (general information on healthy food habits) at discharge, but no nutritional support strategy will be used during follow-up
Other: general nutritional information
general information about health food behavior upon hospital discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to death from any cause (i.e., all-cause mortality)
Time Frame: Enrollment to 3 years
time to death from any cause (i.e., all-cause mortality)
Enrollment to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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 the first major complication
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 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)
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
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 (scores range from 0 to 100, with higher scores indicating better functional status)
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)
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 values range from 0 to 1, with higher scores indicating better quality of life)
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)
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 visual-analogue scale (EQ-5D VAS) (scores range from 0 to 100, with higher scores indicating better health status).
assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
Change in body weight
assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
Change in calf circumference to assess muscle mass
Time Frame: assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
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 bioelectrical impedance analysis (BIA) to assess body composition
Time Frame: 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
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
Time Frame: 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
assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipp Schuetz

Investigators

  • Principal Investigator: Philipp Schuetz, Prof. Dr. med., Kantonsspital Aarau, University Department of Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-00278; ex20Schuetz

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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