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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group: individualized nutritional support | Experimental | 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 |
|
| Control group: general information on healthy food habits | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional supplement | Dietary 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). |
| Measure | Description | Time Frame |
|---|---|---|
| time to death from any cause (i.e., all-cause mortality) | time to death from any cause (i.e., all-cause mortality) | Enrollment to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to non-elective hospital readmission after discharge from the index hospital stay | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | 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 | Change in calf circumference to assess muscle mass |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philipp Schuetz, Prof. Dr. med. | Contact | +41 (0) 62 838 9524 | Philipp.Schuetz@unibas.ch |
| Name | Affiliation | Role |
|---|---|---|
| Philipp Schuetz, Prof. Dr. med. | Kantonsspital Aarau, University Department of Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall Hebron de Barcelona | Recruiting | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41857825 | Derived | Wunderle C, Tribolet P, Kaegi-Braun N, Haller V, Escher R, Aujesky D, Trennepohl Da Costa Heinen G, Brandle M, Bregenzer T, Henzen C, Zehnder T, Schait S, Gassmann C, Dorfschmid M, Ballesteros-Pomar MD, Cuerda C, Burgos R, De Luis D, Olveira G, Rodriguez-Manas L, Stanga Z, Mueller B, Schuetz P. Design and rationale of the EFFORTII project: a multicentric randomised-controlled trial on the impact of continued nutritional therapy at hospital discharge. BMJ Open. 2026 Mar 18;16(3):e115456. doi: 10.1136/bmjopen-2025-115456. |
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Pragmatic, single blinded, open label randomised-controlled trial
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This trial is single blinded (regarding outcome assessment)
| individualized nutritional guidelines | Other | 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. |
|
| general nutritional information | Other | general information about health food behavior upon hospital discharge |
|
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 | 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) | 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) | 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)] |
| 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 | 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 | 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 |
| Hospital Universitario de Getafe | Recruiting | Getafe | Spain |
|
| Complejo AComplejo Asistencial Universitario de León | Recruiting | León | Spain |
|
| Hospital U. Gregorio Marañón de Madrid | Recruiting | Madrid | Spain |
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| Hospital Universitario Regional de Málaga | Recruiting | Málaga | Spain |
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| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | Spain |
|
| Spital Zofingen | Completed | Zofingen | Canton of Aargau | 4800 | Switzerland |
| Spital Emmental Burgdorf | Completed | Burgdorf | Canton of Bern | 3400 | Switzerland |
| Spital Thun | Recruiting | Thun | Canton of Bern | 3600 | Switzerland |
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| Spital Lachen | Recruiting | Lachen | Canton of Schwyz | 8853 | Switzerland |
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| Kantonsspital Münsterlingen | Recruiting | Münsterlingen | Thurgau | 8596 | Switzerland |
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| Kantonsspital Aarau, University Department of Internal Medicine | Recruiting | Aarau | 5001 | Switzerland |
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| Bern University Hospital, Department of General Internal Medicine | Completed | Bern | Switzerland |
| Kantonsspital Lucerne, Department of Internal Medicine | Completed | Lucerne | Switzerland |
| Kantonsspital Sankt Gallen | Completed | Sankt Gallen | 9007 | Switzerland |
| Klinik Hirslanden Zürich | Completed | Zurich | 8032 | Switzerland |
| Stadtspital Zürich | Completed | Zurich | 8063 | Switzerland |
| Universitätsspital Zürich | Completed | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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