Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04926597

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

Led by Philipp Schuetz · Updated on 2024-11-20

1200

Participants Needed

18

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of continued nutritional support after hospital discharge compared to usual care in medical patients at nutritional risk. This trial focuses on adults who have experienced malnutrition, a condition linked to higher risks of death, rehospitalization, and loss of function, especially among elderly and multi-ill patients. Previous studies showed that in-hospital nutritional support helps reduce complications and mortality, but the long-term benefits after discharge remain unclear. Participants are randomly assigned to one of two groups. The intervention group receives customized nutritional support from an experienced dietician to meet their individual energy and protein needs, including oral nutritional supplements as needed. The control group receives general advice on healthy eating habits at discharge without ongoing nutritional support. Follow-up includes regular phone calls every 2 to 4 weeks to monitor adherence and adjust dietary plans as necessary. During the study, participants are monitored for up to three years. Researchers assess key outcomes such as time to death from any cause, hospital readmissions, major complications, and changes in functional status using the Barthel index. Quality of life is measured with the European Quality of Life 5 Dimensions index and a visual-analogue scale at regular intervals by phone. This comprehensive follow-up helps determine whether sustained nutritional support after discharge improves long-term health and recovery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Adult medical patients aged 18 years or older
  • Nutritional risk screening score of 3 points or more, including recent weight loss over 5% in 3 months or reduced food intake in the week before hospital admission
  • Presence of chronic diseases such as cancer, chronic kidney disease, chronic heart failure, COPD, or other chronic conditions lasting 1 year or more requiring ongoing medical care or limiting daily activities
Not Eligible

You will not qualify if you...

  • Patients after surgery
  • Unable to eat or drink by mouth
  • Need for long-term nutrition support
  • Terminal medical condition
  • Acute pancreatitis or acute liver failure
  • Patients discharged to a nursing home
  • Patients unlikely to comply with nutritional support, e.g., due to dementia
  • Hospitalization for COVID-19 requiring intensive care

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 years

Participants receive either individualized nutritional support including oral nutritional supplements and regular dietician phone calls every 2 to 4 weeks, or general information on healthy food habits at discharge without nutritional support.

Phone calls every 2 to 4 weeks for nutritional support group; general information provided at discharge for control group

Follow-up

Duration - Up to 3 years

Participants are monitored for outcomes such as mortality, hospital readmission, functional status, and quality of life via phone calls every 6 months.

Phone calls every 6 months

Trial Site Locations

Total: 18 locations

1

Hospital Universitari Vall Hebron de Barcelona

Barcelona, Spain

Actively Recruiting

2

Hospital Universitario de Getafe

Getafe, Spain

Actively Recruiting

3

Complejo AComplejo Asistencial Universitario de León

León, Spain

Actively Recruiting

4

Hospital U. Gregorio Marañón de Madrid

Madrid, Spain

Actively Recruiting

5

Hospital Universitario Regional de Málaga

Málaga, Spain

Actively Recruiting

6

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Actively Recruiting

7

Spital Zofingen

Zofingen, Canton of Aargau, Switzerland, 4800

Completed

8

Spital Emmental Burgdorf

Burgdorf, Canton of Bern, Switzerland, 3400

Completed

9

Spital Thun

Thun, Canton of Bern, Switzerland, 3600

Actively Recruiting

10

Spital Lachen

Lachen, Canton of Schwyz, Switzerland, 8853

Actively Recruiting

11

Kantonsspital Münsterlingen

Münsterlingen, Thurgau, Switzerland, 8596

Actively Recruiting

12

Kantonsspital Aarau, University Department of Internal Medicine

Aarau, Switzerland, 5001

Actively Recruiting

13

Bern University Hospital, Department of General Internal Medicine

Bern, Switzerland

Completed

14

Kantonsspital Lucerne, Department of Internal Medicine

Lucerne, Switzerland

Completed

15

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland, 9007

Completed

16

Klinik Hirslanden Zürich

Zurich, Switzerland, 8032

Completed

17

Stadtspital Zürich

Zurich, Switzerland, 8063

Completed

18

Universitätsspital Zürich

Zurich, Switzerland, 8091

Completed

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Research Team

P

Philipp Schuetz, Prof. Dr. med.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Design and rationale of the EFFORTII project: a multicentric randomised-controlled trial on the impact of continued nutritional therapy at hospital discharge.

Carla Wunderle, Pascal Tribolet, Nina Kaegi-Braun...

https://pubmed.ncbi.nlm.nih.gov/41857825