Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Geriatric Patients

December 20, 2022 updated by: Christian Bitz, Copenhagen University Hospital at Herlev

Effect of Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Undernourished Geriatric Medical Patients: a Randomized Controlled Trial.

Based on an established Follow-home-programme offered at discharge from hospital the aim of this study is to test a model of how nutritional intervention in elderly patients can be systematized and quality assured in the transition between sectors. Furthermore the aim is to demonstrate that this model has a positive effect on the functioning and well-being of the elderly patient.

The purpose of the Follow-home-programme is to facilitate the transition of the elderly patient between hospital and private home in order to follow-up on any medical, nursing- or retraining-related intervention necessary to the rehabilitation of the patient. However this offer does not focus on nutrition in particular. This is a problem as many elderly patients are known to develop a poor nutritional status due to low appetite, disease etc. Our hypothesis is that adding a systematic nutritional focus to the Follow-home intervention programme will promote the rehabilitation of the elderly patient further.

The nutritional intervention in our study will focus on improving energy- and protein intake and we will measure the effect on the patient's functional abilities, quality of life and rate of hospital readmissions. The intervention model will be based on individualized nutritional counselling by a registered dietician in the patients home.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is designed as a 12 week randomized, controlled intervention study. The study sample will consist of 80 geriatric patients admitted to a medical ward at Herlev University Hospital in Copenhagen, Denmark. The patients will be equally distributed into the control and the intervention group. The control group will follow the usual follow-home programme. The intervention group will also follow this programme, but will additionally be offered 3 home visits by a registered dietician. Interdisciplinary information exchange will take place through established communication channels eg. patient records, visitations.

Before and after the intervention data on the patient eg. hand-grip strength, nutritional status, dietary intake, functional abilities, well-being and activities of daily living will be gathered.

Study Type

Interventional

Enrollment (Actual)

72

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

  • Denmark
    • Copenhagen
      • Herlev, Copenhagen, Denmark, 2730
        • EFFECT, Copenhagen University Hospital at Herlev

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

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Geriatric medical patients
  • Age +70 years
  • Nutritional risk according to the level 1 screen in Nutritional Risk Screening 2002 (NRS2002)
  • Nutritional therapy for at least 3 days and at least in two daily meals during the hospitalization period
  • Participation in the standard Follow-home programme

Exclusion Criteria:

  • Dementia
  • Expected readmissions
  • Terminal disease
  • Non-danish speaking
  • Not able to perform Hand grip test
  • Planning weight reducing diet

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual nutritional therapy
Individual nutritional therapy provided by registered dietician by means of three Home-visits
Dietary supplement: Individual nutritional therapy
Individual nutritional therapy provided by registered dietician by means of three Home-visits
No Intervention: Standard Follow-home programme
Standard Follow-home programme without individual nutritional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hand grip strength
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional status
Time Frame: 12 week
Chair stand, mobility, disability and rehabilitation capacity
12 week
Nutritional status
Time Frame: 12 weeks
Weight, BMI, energy and protein intake, distribution of protein intake
12 weeks
Need of social services
Time Frame: 12 weeks
Home care, home nursing, meals-on-wheels
12 weeks
Readmissions
Time Frame: 6 months before and 1½ year after intervention
6 months before and 1½ year after intervention

Collaborators and Investigators

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

Sponsor

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Christian Bitz, Cand Scient, Copenhagen University Hospital at Herlev

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

March 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 24, 2013

First Submitted That Met QC Criteria

January 24, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFFECT.B01.2012

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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