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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.
 
ClinicalTrials.gov Identifier: NCT03488329
Recruitment Status : Active, not recruiting
First Posted : April 5, 2018
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jonas Anias Svendsen, Herlev Hospital

Tracking Information
First Submitted Date  ICMJE February 15, 2018
First Posted Date  ICMJE April 5, 2018
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
Hospital readmissions [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
  • Mortality [ Time Frame: 30 days, 16 weeks, 6 months ]
  • Weight [ Time Frame: 16 weeks ]
  • Protein intake [ Time Frame: 16 weeks ]
    24 hour recall
  • Energi Intake [ Time Frame: 16 weeks ]
    24 hour recall
  • Appetite [ Time Frame: 16 weeks ]
    SNAQ
  • Health related Quality of life [ Time Frame: 16 weeks ]
    EQ-5D
  • Physical function [ Time Frame: 16 weeks ]
    30-s CST
  • Hospital readmissions [ Time Frame: 30 days, 16 weeks ]
  • Combined adverse advents [ Time Frame: 30 days, 16 weeks, 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
  • Mortality [ Time Frame: 30 days, 8 weeks, 6 months ]
  • Weight [ Time Frame: 16 weeks ]
  • Protein intake [ Time Frame: 16 weeks ]
    24 hour recall
  • Energi Intake [ Time Frame: 16 weeks ]
    24 hour recall
  • Appetite [ Time Frame: 16 weeks ]
    SNAQ
  • Quality of life [ Time Frame: 16 weeks ]
    EQ-5D
  • Physical function [ Time Frame: 16 weeks ]
    30-s CST
  • Hospital readmissions [ Time Frame: 30 days, 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Nutritional Efforts on Discharged Elderly Patients
Official Title  ICMJE Effect of Nutritional Efforts on Discharged Elderly Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Malnutrition
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Experimental: Intervention

    Intervention group

    Individual nutritional therapy

    Intervention: Dietary Supplement: Individual nutritional therapy
  • No Intervention: Control

    Control group

    Standard treatment

Publications * Munk T, Svendsen JA, Knudsen AW, Østergaard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 2, 2019)
207
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2018)
200
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03488329
Other Study ID Numbers  ICMJE 2007-58-0015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonas Anias Svendsen, Herlev Hospital
Study Sponsor  ICMJE Herlev Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Herlev Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP