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

ConditionMalnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilipp Schuetz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

after surgery

unable to ingest oral nutrition

need for long-term nutrition,

terminal condition

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • individualized nutritional guidelines

    Other intervention

    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 intervention

    general information about health food behavior upon hospital discharge

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Intervention group: individualized nutritional supportExperimental treatment 2 interventions
Group B: Control group: general information on healthy food habitsOther 1 intervention

Trial outcomes

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)

Time frame
Enrollment to 3 years

Secondary outcomes

1

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

Time frame
assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
2

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)

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

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)

Time frame
assessed from Day 0 (study enrolment), then every 6 month through phone calls up to end of trial (approx 3 years)]
4

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)

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

Other outcomes

1

Change in body weight

Change in body weight

Time frame
assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
2

Change in calf circumference to assess muscle mass

Change in calf circumference to assess muscle mass

Time frame
assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
3

Change in bioelectrical impedance analysis (BIA) to assess body composition

Change in bioelectrical impedance analysis (BIA) to assess body composition

Time frame
assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits
4

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

Time frame
assessed from Day 0 (study enrolment), then at 3, 6 and 12 months by home visits

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philipp Schuetz

Lead sponsor

Kantonsspital Aarau

Sponsor institution