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Effect of Nutritional Efforts on Discharged Elderly Patients

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Individual nutritional therapy
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Hospital readmissions, Seniors

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unit for Dietetics and Nutrition Research, Herlev hosipital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Intervention group Individual nutritional therapy

Control group Standard treatment

Outcomes

Primary Outcome Measures

Hospital readmissions

Secondary Outcome Measures

Mortality
Weight
Protein intake
24 hour recall
Energi Intake
24 hour recall
Appetite
SNAQ
Health related Quality of life
EQ-5D
Physical function
30-s CST
Hospital readmissions
Combined adverse advents

Full Information

First Posted
February 15, 2018
Last Updated
January 5, 2021
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03488329
Brief Title
Effect of Nutritional Efforts on Discharged Elderly Patients
Official Title
Effect of Nutritional Efforts on Discharged Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Hospital readmissions, Seniors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention group Individual nutritional therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group Standard treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Individual nutritional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital readmissions
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
30 days, 16 weeks, 6 months
Title
Weight
Time Frame
16 weeks
Title
Protein intake
Description
24 hour recall
Time Frame
16 weeks
Title
Energi Intake
Description
24 hour recall
Time Frame
16 weeks
Title
Appetite
Description
SNAQ
Time Frame
16 weeks
Title
Health related Quality of life
Description
EQ-5D
Time Frame
16 weeks
Title
Physical function
Description
30-s CST
Time Frame
16 weeks
Title
Hospital readmissions
Time Frame
30 days, 16 weeks
Title
Combined adverse advents
Time Frame
30 days, 16 weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Unit for Dietetics and Nutrition Research, Herlev hosipital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34656032
Citation
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.
Results Reference
derived
PubMed Identifier
32345358
Citation
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.
Results Reference
derived

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Effect of Nutritional Efforts on Discharged Elderly Patients

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