Nutritional Intervention in Geriatric Patients

Study Overview
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Brief Summary
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This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. The intervention consists of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).

Official Title
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A Multidisciplinary Nutritional Intervention Programme Across Sectors to Improve the Nutritional Status of Geriatric Patients at Nutritional Risk - A Randomized Controlled Trial.

Conditions
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Malnutrition

Intervention / Treatment
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* Behavioral: Nutritional intervention programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 or above BMI <20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill Exclusion Criteria: Terminal illness Active cancer diagnosis Permanently living in a nursing home Not willing or able to give an informed consent.

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: Parallel Assignment
Interventional Model Description: Eligible patients were randomized to either the intervention group or control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional intervention programme<br>An individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks). | Behavioral: Nutritional intervention programme<br>* The intervention consisted of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks) conducted by a district nurse.<br>|
| No Intervention: Usual care<br>Usual care which means no individual dietary plan and no nutrition follow-up visits after discharge. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Change in body weight (kg) | Three months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status | Barthel Index (scale 0-100) | Three months follow-up | 
| Functional status | Handgrip strength (kg) | Three months follow-up | 
| Self-rated health | Self-rated health was measured with one single question with 5 possible responses on a Likert scale: In general, how would you rate your Health? | Three months follow-up | 
| Re-admission | All-cause unplanned readmissions | Up to three months | 
| Mortality | All-cause mortality | 1) Up to 90 days after discharge 2) Up to 120 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geriatrics, Nutritional risk, Multi-disciplinary intervention, Randomized Controlled Trial