Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of nutritional therapy in elderly malnourished patients. The hypothesises are that nutritional supplementation and dietary advice alone or in combination affects mortality, quality of life and health-care consumption after six month of treatment.

Official Title
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Effects of Six Months Treatment With Nutritional Supplements or Dietary Advice, Alone or in Combination on Mortality, Health-related Quality of Life and Health-care Consumption for Elderly Patients at Risk of Malnutrition.

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Nutritional supplementation with a liquid formula
* Other: Dietary advice
* Other: Combination of supplement and dietary advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥65 years old Admitted to one of the participating wards during the recruitment period Exclusion Criteria: Well-nourished No consent to participate Not able to communicate Not able to understand swedish Presumed life-expectancy <1 year Already receiving nutritional therapy including dietary advice, supplements, tube-feeding or parenteral nutrition Dietary restrictions due to illness or disease inconsistent with the intervention Impaired cognitive function or dementia Body mass index ≥35 Living in old peoples homes, sheltered housing, institution, service flats or nursing homes Participant in a study evaluating differences in 3-year mortality between well-nourished patients, patients at risk of malnutrition and malnourished patients

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplemention<br> | Dietary Supplement: Nutritional supplementation with a liquid formula<br>* The patient consumes 400 kcal from a liquid supplementation formula<br>|
| Experimental: Dietary advice<br> | Other: Dietary advice<br>* The patient receives dietary advice for one hour during the hospital stay.<br>|
| Experimental: Combination treatment<br> | Other: Combination of supplement and dietary advice<br>* The patient receives dietary advice for one hour during the hospital stay and consumes 400 kcal from liquid supplementation formula for six month after discharge.<br>|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | Six months, one year, three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life |  | Six months, one year, three years | 
| Health-care consumption |  | Six months, one year, three years | 
| Function in activities in daily life |  | Six months, one year, three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Malnutrition, Aged, Aged 80 and over, Nutrition therapy