Effect of Nutritional Efforts on Discharged Elderly Patients

Sponsor
Herlev Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03488329
Collaborator
(none)
207
1
2
22
9.4

Study Details

Study Description

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
  • Dietary Supplement: Individual nutritional therapy
N/A

Study Design

Study Type:
Interventional
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
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Hospital readmissions [6 months]

Secondary Outcome Measures

  1. Mortality [30 days, 16 weeks, 6 months]

  2. Weight [16 weeks]

  3. Protein intake [16 weeks]

    24 hour recall

  4. Energi Intake [16 weeks]

    24 hour recall

  5. Appetite [16 weeks]

    SNAQ

  6. Health related Quality of life [16 weeks]

    EQ-5D

  7. Physical function [16 weeks]

    30-s CST

  8. Hospital readmissions [30 days, 16 weeks]

  9. Combined adverse advents [30 days, 16 weeks, 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unit for Dietetics and Nutrition Research, Herlev hosipital Herlev Denmark 2730

Sponsors and Collaborators

  • Herlev Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jonas Anias Svendsen, Research Associate, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT03488329
Other Study ID Numbers:
  • 2007-58-0015
First Posted:
Apr 5, 2018
Last Update Posted:
Jan 6, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jonas Anias Svendsen, Research Associate, Herlev Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2021