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Completed

NCT Number: NCT03488329

Effect of Nutritional Efforts on Discharged Elderly Patients

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit for Dietetics and Nutrition Research, Herlev hosipital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individual nutritional therapy

Dietary 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.

Primary outcomes

  1. Hospital readmissions

    Time frame: 6 months

Secondary outcomes

  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. Health related 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

  9. Combined adverse advents

    Time frame: 30 days, 16 weeks, 6 months

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2018
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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