- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01345032
The Effect of Nutrition Follow up After Hospital Discharge in Undernourished Elderly
The Effect of Follow up on Nutrition Intervention After Discharge in Undernourished Geriatric Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aarhus, Denmark, 8000
- Aarhus Universityhospital, Geriatric Department
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Aarhus, Denmark, 8000
- geriatric Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home visits
Nutritional follow-up after discharge, conducted as nutritional counselling performed as in-person counselling in the participants homes
|
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:
|
|
Experimental: Telephone consultation
Nutritional follow-up after discharge, conducted as nutritional counselling performed as 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:
|
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No Intervention: Control
No follow-up after discharge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional ability.
Time Frame: Between discharge and 8 weeks after discharge
|
Measurements: Barthel-100 Index, Cumulated Ambulation Score (CAS), handgrip strength, part of senior fitness test,fatigue test (Avlund)
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Between discharge and 8 weeks after discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life
Time Frame: Between discharge and 8 weeks after discharge
|
Measurements: SF-36, geriatric depression score (GDS), depression list (DL)
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Between discharge and 8 weeks after discharge
|
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Mortality
Time Frame: Between discharge and 30 after discharge
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Between discharge and 30 after discharge
|
|
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Readmission to hospital
Time Frame: Between discharge and 30 days after discharge
|
Between discharge and 30 days after discharge
|
|
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Readmission
Time Frame: Between discharge and 90 days after discharge
|
Between discharge and 90 days after discharge
|
|
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Mortality
Time Frame: Between discharge and 90 days after discharge
|
Between discharge and 90 days after discharge
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23012011
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.
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