Continued nutritional support after hospital discharge for malnourished patients
Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery Trial: The EFFORT II Project
This study is testing if extra nutritional support after leaving the hospital can help malnourished patients recover better and live longer compared to standard home nutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kantonsspital Aarau Academic / other |
| Locations | 18 sites (Barcelona and 17 other locations) |
| Trial ID | NCT04926597 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of ongoing nutritional support on malnourished medical patients after they are discharged from the hospital. It compares the outcomes of patients receiving individualized nutritional supplements to those receiving standard home nutrition. The research focuses on how sustained nutritional intervention can impact mortality, frailty, and functional recovery in this vulnerable population. By analyzing the long-term benefits of nutritional support, the study seeks to address gaps in current post-discharge care for patients at nutritional risk.
Who should consider this trial
Good fit: Ideal candidates for this study are adult medical patients aged 18 and older who are at nutritional risk due to conditions like cancer, chronic kidney disease, or chronic heart failure.
Not a fit: Patients who are unable to ingest oral nutrition or have terminal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce mortality and improve recovery outcomes for malnourished patients after hospital discharge.
How similar studies have performed: Previous studies have shown that nutritional support during hospitalization can reduce complications and mortality, but this approach of continued support post-discharge is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barcelona and 17 other locations
- Hospital Universitari Vall Hebron de Barcelona — Barcelona, Spain (Recruiting)
- Hospital Universitario de Getafe — Getafe, Spain (Recruiting)
- Complejo AComplejo Asistencial Universitario de León — León, Spain (Recruiting)
- Hospital U. Gregorio Marañón de Madrid — Madrid, Spain (Recruiting)
- Hospital Universitario Regional de Málaga — Málaga, Spain (Recruiting)
- Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)
- Spital Zofingen — Zofingen, Canton of Aargau, Switzerland (Completed)
- Spital Emmental Burgdorf — Burgdorf, Canton of Bern, Switzerland (Completed)
- Spital Thun — Thun, Canton of Bern, Switzerland (Recruiting)
- Spital Lachen — Lachen, Canton of Schwyz, Switzerland (Recruiting)
- Kantonsspital Münsterlingen — Münsterlingen, Thurgau, Switzerland (Recruiting)
- Kantonsspital Aarau, University Department of Internal Medicine — Aarau, Switzerland (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, Switzerland (Completed)
- Klinik Hirslanden Zürich — Zurich, Switzerland (Completed)
- Stadtspital Zürich — Zurich, Switzerland (Completed)
- Universitätsspital Zürich — Zurich, Switzerland (Completed)
Study contacts
- Principal investigator: Philipp Schuetz, Prof. Dr. med. — Kantonsspital Aarau, University Department of Internal Medicine
- Study coordinator: Philipp Schuetz, Prof. Dr. med.
- Email: Philipp.Schuetz@unibas.ch
- Phone: +41 (0) 62 838 9524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.