NCT03488329

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

February 15, 2018

Last Update Submit

January 5, 2021

Conditions

Malnutrition

Keywords

Hospital readmissionsSeniors

Outcome Measures

Primary Outcomes (1)

  • Hospital readmissions

    6 months

Secondary Outcomes (9)

  • Mortality

    30 days, 16 weeks, 6 months

  • Weight

    16 weeks

  • Protein intake

    16 weeks

  • Energi Intake

    16 weeks

  • Appetite

    16 weeks

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group Individual nutritional therapy

Dietary Supplement: Individual nutritional therapy

Control

NO INTERVENTION

Control group Standard treatment

Interventions

Individual nutritional therapyDIETARY_SUPPLEMENT

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.

Intervention

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Dietetics and Nutrition Research, Herlev hosipital

Herlev, 2730, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 34656032DERIVED

  • Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Beck AM. Effect of nutritional interventions on discharged older patients: study protocol for a randomized controlled trial. Trials. 2020 Apr 28;21(1):365. doi: 10.1186/s13063-020-04301-6.

    PMID: 32345358DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

February 15, 2018

First Posted

April 5, 2018

Study Start

May 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)