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

NCT ID: NCT01345032

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Under Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home visits

Nutritional follow-up after discharge, conducted as nutritional counselling performed as in-person counselling in the participants homes

Group Type EXPERIMENTAL

Home visit

Intervention Type OTHER

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.

Telephone consultation

Nutritional follow-up after discharge, conducted as nutritional counselling performed as telephone consultation

Group Type EXPERIMENTAL

Telephone consultation

Intervention Type OTHER

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.

Control

No follow-up after discharge

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home visit

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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Aged 75 and over Living alone Receive help for home care services Dietary advice after discharge by home visits Aged 75 and over Living alone Receive help for home care services Dietary advice after discharge by telephone consultation

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jette Lindegaard Pedersen

Clinical research nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jette Lindegaard Pedersen, MHSc.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Else Marie S. Damsgaard, Professor

Role: STUDY_CHAIR

Aarhus University Hospital

Preben Ulrich Pedersen, Ph.D.

Role: STUDY_CHAIR

University of Aarhus

Locations

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Aarhus Universityhospital, Geriatric Department

Aarhus, , Denmark

Site Status

Geriatric Department

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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23012011

Identifier Type: -

Identifier Source: org_study_id