MalnutritionEFFORT IINCT04926597
Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery
A study testing nutritional supplement, individualized nutritional guidelines and general nutritional information in people with Malnutrition, run by Philipp Schuetz at 18 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- nutritional supplement, individualized nutritional guidelines and general nutritional information
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 5 Aug 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
Switzerland12 sites, 4 recruiting
- Recruiting
Kantonsspital Aarau, University Department of Internal Medicine
Aarau, 5001
Philipp Schuetz, Prof. Dr. med., +41 (0) 62 838 9524, Philipp.Schuetz@unibas.ch
Philipp Schuetz, Prof. Dr. med.
- Completed
Bern University Hospital, Department of General Internal Medicine
Bern
- Completed
Spital Emmental Burgdorf
Burgdorf, Canton of Bern, 3400
- Recruiting
Spital Lachen
Lachen, Canton of Schwyz, 8853
Thomas Bregenzer, Dr. med., +41 55 451 31 03, thomas.bregenzer@spital-lachen.ch
Thomas Bregenzer, Dr. med.
- Completed
Kantonsspital Lucerne, Department of Internal Medicine
Lucerne
- Recruiting
Kantonsspital Münsterlingen
Münsterlingen, Thurgau, 8596
Vojtech Pavlicek, Dr. med.
Vojtech Pavlicek, Dr. med.
- Completed
Kantonsspital Sankt Gallen
Sankt Gallen, 9007
- Recruiting
Spital Thun
Thun, Canton of Bern, 3600
Thomas Zehnder, Dr. med., +41 33 226 26 49, thomas.zehnder@spitalstsag.ch
Thomas Zehnder, Dr. med.
- Completed
Spital Zofingen
Zofingen, Canton of Aargau, 4800
- Completed
Klinik Hirslanden Zürich
Zurich, 8032
- Completed
Stadtspital Zürich
Zurich, 8063
- Completed
Universitätsspital Zürich
Zurich, 8091
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Vall Hebron de Barcelona
Barcelona
Rosa Burgos Peláez, Dr. med., rosa.burgos@vallhebron.cat
- Recruiting
Hospital Universitario de Getafe
Getafe
Leocardio Rodríguez Mañas, Dr. med., leocadio.rodriguez@salud.madrid.org
- Recruiting
Complejo AComplejo Asistencial Universitario de León
León
María Ballesteros, Dr. med., mdballesteros@telefonica.net
- Recruiting
Hospital U. Gregorio Marañón de Madrid
Madrid
Christina Cuerda, Dr. med., cuerda.cristina@gmail.com
- Recruiting
Hospital Universitario Regional de Málaga
Málaga
Gabriel Olveira Fuster, Dr. med., gabrielm.olveira.sspa@juntadeandalucia.es
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid
Daniel de Luis Román, Dr. med., dluisro@saludcastillayleon.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- nutritional supplement, individualized nutritional guidelines, general nutritional information
- Keywords
- Nutritional Support, Oral Nutritional Supplements, Frailty, Mortality, Morbidity
- Medical subject headings
- Malnutrition, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional supplementDietary 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).
individualized nutritional guidelinesOther
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 informationOther
general information about health food behavior upon hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: nutritional supplement; Other: individualized nutritional guidelines |
| 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 Receives: Other: general nutritional information |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to death from any cause (i.e., all-cause mortality)
time to death from any cause (i.e., all-cause mortality)
Measured: Enrollment to 3 years
Secondary outcomes (5)
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
Measured: 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 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start5 Aug 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, single blinded, open label randomised-controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipp Schuetz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philipp Schuetz, Kantonsspital Aarau
- Investigators
- Philipp Schuetz, Prof. Dr. med., Principal investigator, Kantonsspital Aarau, University Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926597
- Sponsor's protocol ID
- 2021-00278; ex20Schuetz
- Acronym
- EFFORT II
- Status last verified
- Nov 2024
- First submitted
- 1 Jun 2021
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41857825
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery Trial: The EFFORT II Project
- ClinicalTrials.gov ID
- NCT04926597
- Acronym / sponsor ID
- EFFORT II / 2021-00278; ex20Schuetz
- Conditions
- Malnutrition
- Keywords
- Nutritional Support, Oral Nutritional Supplements, Frailty, Mortality, Morbidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Philipp SchuetzUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, single blinded, open label randomised-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group: individualized nutritional support | Experimental | Dietary Supplement: nutritional supplement, Other: individualized nutritional guidelinesIntervention 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 | Other: general nutritional informationControl 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (8 listed)
- after surgery
- unable to ingest oral nutrition
- need for long-term nutrition,
- terminal condition
- acute pancreatitis or acute liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional supplementdaily 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). | Dietary supplement | Intervention group: individualized nutritional support |
| individualized nutritional guidelinesnutritional 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 | Intervention group: individualized nutritional support |
| general nutritional informationgeneral information about health food behavior upon hospital discharge | Other | Control group: general information on healthy food habits |
Primary outcome
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)
5 secondary outcomes
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 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)]
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 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 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)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 41857825Wunderle 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philipp Schuetz, Prof. Dr. med. principal investigator
Kantonsspital Aarau, University Department of Internal Medicine
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional supplement, individualized nutritional guidelines and general nutritional information in people with Malnutrition, run by Philipp Schuetz at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Switzerland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Schuetz, Prof. Dr. med. (+41 (0) 62 838 9524, Philipp.Schuetz@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to death from any cause (i.e., all-cause mortality) (time frame: Enrollment to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04926597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.