Effect of Nutritional Efforts on Discharged Elderly Patients

January 5, 2021 updated by: Jonas Anias Svendsen, Herlev Hospital

The study is a randomized controlled study, ongoing over 16 weeks. At discharge, the intervention group receives guidance from a clinical dietician, where an individual nutrition plan is made. The dietitian will perform a telephone follow-up after 4 and 30 days. It will also be possible for the participant, relatives or municipality to contact the dietician if nutritional questions arise.

At the time of discharge the intervention group will receive a package containing foods and drinks that will cover their nutritional needs the first day after discharge.

They will also get a goodiebag containing samples on protein-rich milk-based drinks. Data is collected on quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, as well as experience of discharge and cooperation with the municipality.

If there is a need, information about nutrition status will be sent to the municipality so the municipality can take over nutritional treatment.

The control group receives standard treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • 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 Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Unit for Dietetics and Nutrition Research, Herlev hosipital

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted to Oncology, Gastro-medical / Surgical, and Medical Department, HGH, Herlev.
  • Age: 50+
  • At admission, found in nutritional risk score ≥3 according to NRS-2002.
  • On special food concept, Herlev's Glories during hospitalization
  • Discharged to own home in a municipality in Planområde Midt (Ballerup, Herlev, Lyngby-Tårbæk, Gentofte, Gladsaxe, Rødovre, Egedal, Rudersdal, Furesø).
  • Can read, hear and understand Danish
  • Cognitive able to participate in the study, based on whether they are informed in time, place and own data.

Exclusion Criteria:

  • Food allergy or intolerance
  • Planned weight loss or following a special diet
  • Receives enteral or parenteral nutrition
  • Patients with moderate to severe dysphagia, defined with a need for gratin or a creamy diet
  • Patients who does not want a food package or goodiebag
  • Patients who are permanently bedridden
  • Patients who are discharged to nursing homes or rehabilitation
  • Patients in isolation
  • Late palliative patients
  • Terminal patients

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

Intervention group

Individual nutritional therapy
Dietary supplement: Individual nutritional therapy

Guidance from a clinical dietician.

Individual nutrition plan

A package containing foods and drinks, which will cover their nutritional needs the first day after discharge.

A goodiebag containing samples on protein-rich milk-based drinks.

Telephone follow-up after 4 and 30 days and the possibility to call the dietician in case of questions about nutrition.
No Intervention: Control

Control group

Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital readmissions
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days, 16 weeks, 6 months
30 days, 16 weeks, 6 months
Weight
Time Frame: 16 weeks
16 weeks
Protein intake
Time Frame: 16 weeks
24 hour recall
16 weeks
Energi Intake
Time Frame: 16 weeks
24 hour recall
16 weeks
Appetite
Time Frame: 16 weeks
SNAQ
16 weeks
Health related Quality of life
Time Frame: 16 weeks
EQ-5D
16 weeks
Physical function
Time Frame: 16 weeks
30-s CST
16 weeks
Hospital readmissions
Time Frame: 30 days, 16 weeks
30 days, 16 weeks
Combined adverse advents
Time Frame: 30 days, 16 weeks, 6 months
30 days, 16 weeks, 6 months

Collaborators and Investigators

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

Sponsor

Herlev 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)

May 1, 2018

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-58-0015 (Danish Data Protection Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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