Text Size

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

This study is currently recruiting participants.
Verified December 2011 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Jette Lindegaard Pedersen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01345032
First received: April 28, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Under Nutrition
 Other: Home visit
Other: Telephone consultation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Follow up on Nutrition Intervention After Discharge in Undernourished Geriatric Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Functional ability. [ Time Frame: Between discharge and 8 weeks after discharge ] [ Designated as safety issue: No ]
    Measurements: Barthel-100 Index, Cumulated Ambulation Score (CAS), handgribstrength, part of senior fitness test,fatigue test (Avlund)


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Between discharge and 8 weeks after discharge ] [ Designated as safety issue: No ]
    Measurements: SF-36, geriatric depression score (GDS), depression list (DL)

  • Mortality [ Time Frame: Between discharge and 30 after discharge ] [ Designated as safety issue: No ]
  • Readmission to hospital [ Time Frame: Between discharge and 30 days after discharge ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Between discharge and 30 days after discharge ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Between discharge and 90 days after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home visit Other: 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.
Other Names:
  • Aged 75 and over
  • Living alone
  • Receive help for home care services
  • Dietary advice after discharge by home visits
Experimental: Telephone consultation 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.
Other Names:
  • Aged 75 and over
  • Living alone
  • Receive help for home care services
  • Dietary advice after discharge by telephone consultation
No Intervention: Control

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

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 75 and over
  • undernourished according to Mini Nutritional Assessment (MNA)
  • living alone in own home
  • receive help from the home care services
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345032

Contacts
Contact: Jette Lindegaard Pedersen, MHSc. 0045 8949 1944 jetpeder@m.dk
Contact: Else Marie S. Damsgaard, Professor 0045 8949 1931 elsedams@rm.dk

Locations
Denmark
Geriatric Department Recruiting
Aarhus, Denmark, 8000
Contact: Jette Lindegaard Pedersen, MHSc.     0045 8949 1944     jetpeder@rm.dk    
Contact: Else Marie S. Damsgaard, Professor     0045 8949 1931        
Principal Investigator: Jette Lindegaard Pedersen, MHSc.            
Aarhus Universityhospital, Geriatric Department Recruiting
Aarhus, Denmark, 8000
Contact: Jette Lindegaard Pedersen, MHSc.     0045 8949 1944     jetpeder@rm.dk    
Principal Investigator: Jette Lindegaard Pedersen, MHSc.            
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Jette Lindegaard Pedersen, MHSc. Aarhus University Hospital
Study Chair: Else Marie S. Damsgaard, Professor Aarhus University Hospital
Study Chair: Preben Ulrich Pedersen, Ph.D. University of Aarhus
  More Information

No publications provided

Responsible Party: Jette Lindegaard Pedersen, Development nurse, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01345032     History of Changes
Other Study ID Numbers: 23012011
Study First Received: April 28, 2011
Last Updated: December 20, 2011
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 22, 2013