Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.

November 6, 2020 updated by: Uppsala University

Effects of Six Months Treatment With Nutritional Supplements or Dietary Advice, Alone or in Combination on Mortality, Health-related Quality of Life and Health-care Consumption for Elderly Patients at Risk of Malnutrition.

The purpose of this study is to evaluate the effects of nutritional therapy in elderly malnourished patients. The hypothesises are that nutritional supplementation and dietary advice alone or in combination affects mortality, quality of life and health-care consumption after six month of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

671

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Dalarna
      • Falun, Dalarna, Sweden, 79129
        • Falu Lasarett
    • Sörmland
      • Eskilstuna, Sörmland, Sweden, 61188
        • Mälarsjukhuset in Eskilstuna
      • Nyköping, Sörmland, Sweden, 61188
        • Nyköpings lasarett
    • Uppland
      • Uppsala, Uppland, Sweden, 75125
        • Akademiska Sjukhuset
    • Västmanland
      • Västerås, Västmanland, Sweden, 72189
        • Västmanlands Sjukhus Västerås

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥65 years old
  • Admitted to one of the participating wards during the recruitment period

Exclusion Criteria:

  • Well-nourished
  • No consent to participate
  • Not able to communicate
  • Not able to understand swedish
  • Presumed life-expectancy <1 year
  • Already receiving nutritional therapy including dietary advice, supplements, tube-feeding or parenteral nutrition
  • Dietary restrictions due to illness or disease inconsistent with the intervention
  • Impaired cognitive function or dementia
  • Body mass index ≥35
  • Living in old peoples homes, sheltered housing, institution, service flats or nursing homes
  • Participant in a study evaluating differences in 3-year mortality between well-nourished patients, patients at risk of malnutrition and malnourished patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Supplemention
Dietary supplement: Nutritional supplementation with a liquid formula
The patient consumes 400 kcal from a liquid supplementation formula
Experimental: Dietary advice
Other: Dietary advice
The patient receives dietary advice for one hour during the hospital stay.
Experimental: Combination treatment
Other: Combination of supplement and dietary advice
The patient receives dietary advice for one hour during the hospital stay and consumes 400 kcal from liquid supplementation formula for six month after discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: Six months, one year, three years
Six months, one year, three years

Secondary Outcome Measures

Outcome Measure
Time Frame
Health-related quality of life
Time Frame: Six months, one year, three years
Six months, one year, three years
Health-care consumption
Time Frame: Six months, one year, three years
Six months, one year, three years
Function in activities in daily life
Time Frame: Six months, one year, three years
Six months, one year, three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Västmanland County Council, Sweden

Investigators

  • Principal Investigator: Leif Bergkvist, Centre for clinical research, Landstinget Västmanland/Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTV-69151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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