Nutritional Intervention in Geriatric Patients

April 24, 2017 updated by: Rikke Terp, University Hospital, Gentofte, Copenhagen

A Multidisciplinary Nutritional Intervention Programme Across Sectors to Improve the Nutritional Status of Geriatric Patients at Nutritional Risk - A Randomized Controlled Trial.

This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. The intervention consists of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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:

  • Age 65 or above
  • BMI <20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill

Exclusion Criteria:

  • Terminal illness
  • Active cancer diagnosis
  • Permanently living in a nursing home
  • Not willing or able to give an informed consent.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nutritional intervention programme
An individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).
Behavioral: Nutritional intervention programme
The intervention consisted of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks) conducted by a district nurse.
NO_INTERVENTION: Usual care
Usual care which means no individual dietary plan and no nutrition follow-up visits after discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: Three months follow-up
Change in body weight (kg)
Three months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional status
Time Frame: Three months follow-up
Barthel Index (scale 0-100)
Three months follow-up
Functional status
Time Frame: Three months follow-up
Handgrip strength (kg)
Three months follow-up
Self-rated health
Time Frame: Three months follow-up
Self-rated health was measured with one single question with 5 possible responses on a Likert scale: In general, how would you rate your Health?
Three months follow-up
Re-admission
Time Frame: Up to three months
All-cause unplanned readmissions
Up to three months
Mortality
Time Frame: 1) Up to 90 days after discharge 2) Up to 120 days after discharge
All-cause mortality
1) Up to 90 days after discharge 2) Up to 120 days after discharge

Collaborators and Investigators

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

Sponsor

University Hospital, Gentofte, Copenhagen

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 (ACTUAL)

October 15, 2012

Primary Completion (ACTUAL)

August 17, 2015

Study Completion (ACTUAL)

December 31, 2015

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (ACTUAL)

April 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Geriatric-Project-2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Malnutrition

Clinical Trials on Nutritional intervention programme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe