NCT06706661

Brief Summary

The aim of the study is to implement a nutritional treatment when discharging older patients at risk of malnutrition. Data collected in the study will include an assessment of whether a combination of nutritional treatment and a liaison team reduces the risk of readmissions and mortality, improves nutritional status, physical function and quality of life

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2025Dec 2030

First Submitted

Initial submission to the registry

November 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 6, 2025

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 4, 2025

Status Verified

April 1, 2025

Enrollment Period

6 years

First QC Date

November 22, 2024

Last Update Submit

November 27, 2025

Conditions

Keywords

fooddieticianmalnutritionnutrition riskquality of lifemuscle strengthreadmissionsmortalitymultimodal

Outcome Measures

Primary Outcomes (3)

  • Eligibility

    Eligibility will be assessed as the number of patients who fulfil the inclusion criteria out of the number of patients discharged with the liaison team

    Assessed at baseline

  • Recruitment

    Recruitment rate will be assessed as the number of patients recruited out of the number of eligible patients

    Assessed at baseline

  • Retention

    Retention rate will be assessed as the number of patients who complete the nutritional treatment out of the total number of patients recruited

    Assessed at three months

Secondary Outcomes (8)

  • Mortality

    30 days, 12 weeks, 6 monts, 1 year and 3 year

  • Hospital re-admissions

    30 days, 12 weeks, 6 monts, 1 year and 3 year

  • Health related Quality of life

    12 weeks

  • Appetite

    30 days, 12 weeks

  • Muscle strenght

    4 days, 30 days, 12 weeks

  • +3 more secondary outcomes

Study Arms (1)

Nutritional treament

EXPERIMENTAL

At the day of discharge the intervention group (IG) receives a package containing foods and drinks covering dietary requirements for the next 24 h. Further, a goodie-bag containing samples of protein-rich milk-based drinks is provided. At day 4 after discharge, the IG receives dietetic counselling including a recommendation of daily exercise, and an individual nutrition plan. Information regarding recommendations of nutritional therapy after discharge is systematically and electronically communicated to the municipality. The dietician performes telephone follow-ups on day 30 and a home visit at 12 weeks

Other: Nutritional treatment

Interventions

At the day of discharge the intervention group (IG) receives a package containing foods and drinks covering dietary requirements for the next 24 h. Further, a goodie-bag containing samples of protein-rich milk-based drinks is provided. At day 4 after discharge, the IG receives dietetic counselling including a recommendation of daily exercise, and an individual nutrition plan. Information regarding recommendations of nutritional therapy after discharge is systematically and electronically communicated to the municipality. The dietician performes telephone follow-ups on day 30 and a home visit at 12 weeks

Nutritional treament

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prescription of the Liaison team At nutritional risk according to NRS2002 Age 50+ Can read, hear and understand Danish or English Cognitive able to participate in the study, based on whether they are informed in time, place and own data

You may not qualify if:

  • Receives enteral or parenteral nutrition Following a special diet including texture modified food and drinks Short life expectancy Not deemed eligible by the project staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

Related Publications (2)

  • Beck A, Andersen UT, Leedo E, Jensen LL, Martins K, Quvang M, Rask KO, Vedelspang A, Ronholt F. Does adding a dietician to the liaison team after discharge of geriatric patients improve nutritional outcome: a randomised controlled trial. Clin Rehabil. 2015 Nov;29(11):1117-28. doi: 10.1177/0269215514564700. Epub 2014 Dec 31.

  • Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Thomsen T, Olesen SS, Rasmussen HH, Beck AM. A multimodal nutritional intervention after discharge improves quality of life and physical function in older patients - a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5500-5510. doi: 10.1016/j.clnu.2021.09.029. Epub 2021 Sep 24.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Tina Munk, Ph D

CONTACT

Anne Marie Beck, Ph.d.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 26, 2024

Study Start

January 6, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

December 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Due to GDPR

Locations