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

Primary Purpose

Under Nutrition

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Home visit
Telephone consultation
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Under Nutrition

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus Universityhospital, Geriatric Department
  • Geriatric Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Home visits

Telephone consultation

Control

Arm Description

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

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

No follow-up after discharge

Outcomes

Primary Outcome Measures

Functional ability.
Measurements: Barthel-100 Index, Cumulated Ambulation Score (CAS), handgrip strength, part of senior fitness test,fatigue test (Avlund)

Secondary Outcome Measures

Quality of Life
Measurements: SF-36, geriatric depression score (GDS), depression list (DL)
Mortality
Readmission to hospital
Readmission
Mortality

Full Information

First Posted
April 28, 2011
Last Updated
December 30, 2015
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01345032
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Under Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home visits
Arm Type
Experimental
Arm Description
Nutritional follow-up after discharge, conducted as nutritional counselling performed as in-person counselling in the participants homes
Arm Title
Telephone consultation
Arm Type
Experimental
Arm Description
Nutritional follow-up after discharge, conducted as nutritional counselling performed as telephone consultation
Arm Title
Control
Arm Type
No Intervention
Arm Description
No follow-up after discharge
Intervention Type
Other
Intervention Name(s)
Home visit
Other Intervention Name(s)
Aged 75 and over, Living alone, Receive help for home care services, Dietary advice after discharge by home visits
Intervention Description
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
Intervention Name(s)
Telephone consultation
Other Intervention Name(s)
Aged 75 and over, Living alone, Receive help for home care services, Dietary advice after discharge by telephone consultation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional ability.
Description
Measurements: Barthel-100 Index, Cumulated Ambulation Score (CAS), handgrip strength, part of senior fitness test,fatigue test (Avlund)
Time Frame
Between discharge and 8 weeks after discharge
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Measurements: SF-36, geriatric depression score (GDS), depression list (DL)
Time Frame
Between discharge and 8 weeks after discharge
Title
Mortality
Time Frame
Between discharge and 30 after discharge
Title
Readmission to hospital
Time Frame
Between discharge and 30 days after discharge
Title
Readmission
Time Frame
Between discharge and 90 days after discharge
Title
Mortality
Time Frame
Between discharge and 90 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jette Lindegaard Pedersen, MHSc.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Else Marie S. Damsgaard, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Preben Ulrich Pedersen, Ph.D.
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus Universityhospital, Geriatric Department
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Geriatric Department
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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