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

NCT04926597 | Recruiting

• 1 other identifier: 2021-00278; ex20Schuetz
• Study Type: interventional
• Target: 1,200
• Locations: 2 countries
• Sites: 18

Brief 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.

Conditions

Malnutrition

Keywords

Nutritional Support; Oral Nutritional Supplements; Frailty; Mortality; Morbidity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

  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

  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)

  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)

  assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]

Other Outcomes (4)

• 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

  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

Study Arms (2)

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

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

Other: general nutritional information

Interventions

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).

Intervention group: individualized nutritional support

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.

Intervention group: individualized nutritional support

general nutritional information OTHER

general information about health food behavior upon hospital discharge

Control group: general information on healthy food habits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipp Schuetz: lead

Study Sites (18)

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, 4800, Switzerland

COMPLETED

Spital Emmental Burgdorf

Burgdorf, Canton of Bern, 3400, Switzerland

COMPLETED

Spital Thun

Thun, Canton of Bern, 3600, Switzerland

RECRUITING

Spital Lachen

Lachen, Canton of Schwyz, 8853, Switzerland

RECRUITING

Kantonsspital Münsterlingen

Münsterlingen, Thurgau, 8596, Switzerland

RECRUITING

Kantonsspital Aarau, University Department of Internal Medicine

Aarau, 5001, 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, 9007, Switzerland

COMPLETED

Klinik Hirslanden Zürich

Zurich, 8032, Switzerland

COMPLETED

Stadtspital Zürich

Zurich, 8063, Switzerland

COMPLETED

Universitätsspital Zürich

Zurich, 8091, Switzerland

COMPLETED

MeSH Terms

Conditions

Malnutrition; Frailty

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Philipp Schuetz, Prof. Dr. med.

  Kantonsspital Aarau, University Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Schuetz, Prof. Dr. med.

CONTACT

+41 (0) 62 838 9524; Philipp.Schuetz@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This trial is single blinded (regarding outcome assessment)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Pragmatic, single blinded, open label randomised-controlled trial

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 15, 2021
• Study Start: August 5, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CH (12); ES (6)