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Trial record 1 of 1 for:    Jonas Anias Svendsen
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Effect of Nutritional Efforts on Discharged Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03488329
Recruitment Status : Active, not recruiting
First Posted : April 5, 2018
Last Update Posted : February 18, 2020
Information provided by (Responsible Party):
Jonas Anias Svendsen, Herlev Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Individual nutritional therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Nutritional Efforts on Discharged Elderly Patients
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Hospital readmissions [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days, 16 weeks, 6 months ]
  2. Weight [ Time Frame: 16 weeks ]
  3. Protein intake [ Time Frame: 16 weeks ]
    24 hour recall

  4. Energi Intake [ Time Frame: 16 weeks ]
    24 hour recall

  5. Appetite [ Time Frame: 16 weeks ]

  6. Health related Quality of life [ Time Frame: 16 weeks ]

  7. Physical function [ Time Frame: 16 weeks ]
    30-s CST

  8. Hospital readmissions [ Time Frame: 30 days, 16 weeks ]
  9. Combined adverse advents [ Time Frame: 30 days, 16 weeks, 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03488329

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Unit for Dietetics and Nutrition Research, Herlev hosipital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jonas Anias Svendsen, Research Associate, Herlev Hospital Identifier: NCT03488329    
Other Study ID Numbers: 2007-58-0015
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonas Anias Svendsen, Herlev Hospital:
Hospital readmissions
Additional relevant MeSH terms:
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Nutrition Disorders