Clinical trial NCT01345032: The Effect of Nutrition Follow up After Hospital Discharge in Undernourished Elderly
Official title: The Effect of Follow up on Nutrition Intervention After Discharge in Undernourished Geriatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Under Nutrition
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 208
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional ability.
timeFrame: Between discharge and 8 weeks after discharge
Secondary outcomes:
measure: Quality of Life
timeFrame: Between discharge and 8 weeks after discharge
measure: Mortality
timeFrame: Between discharge and 30 after discharge
measure: Readmission to hospital
timeFrame: Between discharge and 30 days after discharge
measure: Readmission
timeFrame: Between discharge and 90 days after discharge
measure: Mortality
timeFrame: Between discharge and 90 days after discharge
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universityhospital, Geriatric Department
city: Aarhus
country: Denmark
facility: Geriatric Department
Study officials:
affiliation: Aarhus University Hospital
name: Jette Lindegaard Pedersen, MHSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Else Marie S. Damsgaard, Professor
role: STUDY_CHAIR
affiliation: University of Aarhus
name: Preben Ulrich Pedersen, Ph.D.
role: STUDY_CHAIR
References: