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Effect of Nutritional Efforts on Discharged Elderly Patients

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ClinicalTrials.gov Identifier: NCT03488329
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : May 11, 2018
Sponsor:
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)
Estimated Enrollment : 200 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 : January 2020
Estimated Study Completion Date : January 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 ]
    SNAQ

  6. Quality of life [ Time Frame: 16 weeks ]
    EQ-5D

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

  8. Hospital readmissions [ Time Frame: 30 days, 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to Oncology, Gastro-medical / Surgical, and Medical Department, HGH, Herlev.
  • Age: 65+
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03488329


Contacts
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Contact: Jonas A Svendsen, MSc 38681448 ext 45 jonas.anias.svendsen@regionh.dk
Contact: Tina Munk, Ph.D. 61160138 ext 45 tina.munk@regionh.dk

Locations
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Denmark
Unit for Dietetics and Nutrition Research, Herlev hosipital Recruiting
Herlev, Denmark, 2730
Contact: Tina Munk, PhD    61160138 ext 45    tina.munk@regionh.dk   
Contact: Jonas A Svendsen, MSc    38681448 ext 45    jonas.anias.svendsen@regionh.dk   
Sponsors and Collaborators
Herlev Hospital

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Responsible Party: Jonas Anias Svendsen, Research Associate, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03488329     History of Changes
Other Study ID Numbers: 2007-58-0015
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
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
Seniors
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders