Implementation of Nutritional Efforts on Discharged Older Patients (KMH2)

July 3, 2026 updated by: Anne Marie Beck, Herlev and Gentofte Hospital

Implementation of Nutritional Treatment to Older Patients Discharged With the Liaison Team

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During hospitalization, many older patients are at risk of malnutrition. Malnutrition in older adults is related to reduced physical function, more complications, re-admissions, days in hospital and reduced quality of life. As hospitalizations are often short (approximately 5 days), it is important to focus on nutritional intake during the convalescence period.

Upon discharge, a "Nutrition Gap" often occurs in practice, where the patient does not consume sufficient nutrition to ensure an optimal convalescence period. The lack of nutritional follow-up in connection with the discharge of older patients has been shown to have a markedly negative effect on, among other things, functional ability and readmissions. A study from Herlev Hospital, where the effect of a nutritional treatment upon discharge of older patients was investigated, showed a significant effect on muscle strength, quality of life and nutritional status. Another study from Herlev Hospital has shown that by associating a clinical dietitian with a liaison team and thus focusing on nutrition, the readmission rate was halved.

The problem is that it has not been investigated whether such a cross-sectoral effort can be implemented in practice and the results confirmed.

Hypothesis 1 is that it is possible to include and retain the older patients who are discharged with the liaison team for an effort that includes treatment of the risk of malnutrition and that the older participants find the effort relevant

Hypothesis 2 is that nutritional treatment will be able to reduce the number of unintended readmissions and thereby be cost-effective. Furthermore, it is expected that the nutritional treatment will increase the participants' nutritional status, muscle strength, muscle mass, quality of life and possibly have a positive effect on mortality.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Anne Marie Beck, Ph.d.
  • Phone Number: +45 38682387

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital
        • Contact:
        • Contact:
          • Tina Munk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nutritional treament
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eligibility
Time Frame: Assessed at baseline
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
Time Frame: Assessed at baseline
Recruitment rate will be assessed as the number of patients recruited out of the number of eligible patients
Assessed at baseline
Retention
Time Frame: Assessed at three months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital re-admissions
Time Frame: 30 days, 12 weeks, 6 monts, 1 year and 3 year
health care records
30 days, 12 weeks, 6 monts, 1 year and 3 year
Mortality
Time Frame: 30 days, 12 weeks, 6 monts, 1 year and 3 year
health care records
30 days, 12 weeks, 6 monts, 1 year and 3 year
Health related Quality of life
Time Frame: 12 weeks
Euro-qol tool EQ5D5L
12 weeks
Muscle strenght
Time Frame: 4 days, 30 days, 12 weeks
30 seconds chair stand
4 days, 30 days, 12 weeks
Dietary intake
Time Frame: 30 days, 12 weeks
24 hours recall
30 days, 12 weeks
weight
Time Frame: 4 days, 30 days
body weight measurement
4 days, 30 days
muscle mass
Time Frame: 12 weeks
calf circumference
12 weeks
Appetite
Time Frame: 30 days, 12 weeks
SNAQ with a score from 5 to 20 where a score at or below 14 can predict weight loss
30 days, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Herlev and Gentofte Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F-24065575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to GDPR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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