The Effect of Nutrition Follow up After Hospital Discharge in Undernourished Elderly

December 30, 2015 updated by: Jette Lindegaard Pedersen, Aarhus University Hospital

The Effect of Follow up on Nutrition Intervention After Discharge in Undernourished Geriatric Patients

The purpose of this study is to test two different interventions of nutrition follow up after discharge from geriatric ward in undernourished geriatric patients. The patients are randomized to a home visit arm, a telephone consultation arm, or a control arm. Patients in the home visit arm and their home care helper will get visits from a clinical dietician at one week, two weeks and four weeks after discharge, in order to follow up on the nutrition intervention. Patients in the telephone consultation arm and their home care helper will be contacted by a clinical dietician at one week, two weeks and four weeks after discharge, in order to follow up on the nutrition intervention. The control arm will not be contacted.

The primarily outcome is functional ability. Secondary outcomes are quality of life, readmission and mortality.

Study Overview

Status

Completed

Conditions

Detailed Description

Under nutrition among geriatric patients is a recurrent and well documented problem. Up to 55 % of the elderly are undernourished at the time of admission. Hospitalisation and acute illness are associated to loss of muscles and physical ability, complications, dependency, morbidity and mortality. Elderly who live alone are more vulnerable to nutritional problems, than elderly who live together with another person or in a nursing home. Geriatric patients, who are admitted to geriatric ward Aarhus University Hospital due to various acute somatic disorders, aged 75 and older and who are living alone with help from the home care facilities can participate in the study. According to the power calculation 150 patients must be included, 50 patients in each arm of the study. Informed consent will be obtained before inclusion and discharge from hospital. Randomization will be computerised and determine if the patient will be allocated to the "home visit" group, the "telephone consultation" group or the "control group". Patients who suffer from mental disorder (MMSE<22) or active cancer are excluded as well as patients who live together with another person or live in a nursing home. During hospitalisation the three groups will receive the same nutritional care as all patients in nutritional risk. This includes nutritional intervention during hospitalization and an individual diet plan at discharge. Patients in the home visit arm will get visits from a clinical dietician at one week, two weeks and four weeks after discharge. Patients in the telephone consultation arm will be contacted by a clinical dietician at one week, two weeks and four weeks after discharge. In both intervention groups the patients and their home care helpers will get dietary advice and follow up on their individual diet plan. The main outcome is functional ability from discharge and to 8 weeks after discharge. Secondary outcomes are quality of life, readmission at 30 and 90 days and mortality at 30 and 90 days.

Study Type

Interventional

Enrollment (Actual)

208

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

      • Aarhus, Denmark, 8000
        • Aarhus Universityhospital, Geriatric Department
      • Aarhus, Denmark, 8000
        • geriatric Department

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 75 and over
  • undernourished according to Mini Nutritional Assessment (MNA)
  • living alone in own home
  • admitted and discharged from geriatric ward Aarhus, Denmark, due to various acute somatic disorders

Exclusion Criteria:

  • active cancer
  • mental disorder (MMSE<22)
  • live together with another person
  • live in a nursing home

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home visits
Nutritional follow-up after discharge, conducted as nutritional counselling performed as in-person counselling in the participants homes
Patients and their homecare helper will receive visits from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the visits is follow up on the individual diet plan distributed at discharge and supply dietary advice.
Other Names:
  • Aged 75 and over
  • Living alone
  • Receive help for home care services
  • Dietary advice after discharge by home visits
Experimental: Telephone consultation
Nutritional follow-up after discharge, conducted as nutritional counselling performed as telephone consultation
Patients and their homecare helper will be contacted on telephone from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the telephone contact is follow up on the individual diet plan distributed at discharge and supply dietary advice.
Other Names:
  • Aged 75 and over
  • Living alone
  • Receive help for home care services
  • Dietary advice after discharge by telephone consultation
No Intervention: Control
No follow-up after discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional ability.
Time Frame: Between discharge and 8 weeks after discharge
Measurements: Barthel-100 Index, Cumulated Ambulation Score (CAS), handgrip strength, part of senior fitness test,fatigue test (Avlund)
Between discharge and 8 weeks after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Between discharge and 8 weeks after discharge
Measurements: SF-36, geriatric depression score (GDS), depression list (DL)
Between discharge and 8 weeks after discharge
Mortality
Time Frame: Between discharge and 30 after discharge
Between discharge and 30 after discharge
Readmission to hospital
Time Frame: Between discharge and 30 days after discharge
Between discharge and 30 days after discharge
Readmission
Time Frame: Between discharge and 90 days after discharge
Between discharge and 90 days after discharge
Mortality
Time Frame: Between discharge and 90 days after discharge
Between discharge and 90 days after discharge

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Jette Lindegaard Pedersen, MHSc., Aarhus University Hospital
  • Study Chair: Else Marie S. Damsgaard, Professor, Aarhus University Hospital
  • Study Chair: Preben Ulrich Pedersen, Ph.D., University of Aarhus

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

June 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23012011

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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