Nutritional Support in Patients With Nutritional Risk. How we Can Improved the Prognosis and Quality of Life

Study Overview
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Brief Summary
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Background: Many malnourished hospital patients remain after discharge. We aimed to enhance the meal experience after discharge by delivering meals together with physical support at the home and tested if this increased food intake affected survival and quality of life. Patients and Methods: 60 discharged patients suffering from nutritional (MUST>2) and financial frailty were included. Control group (C) took their regular nutrition at home for 6 months and study group (S) received a daily dinner tray sponsored by the municipality. Hazalla philanthropic organization encouraged the patients at lunch for 6 months. Body composition (Quadstat 4000, Bodystat, UK), energy requirements (Fitmate- COSMED, Italy) were measured at recruitement. Primary outcome was 180 days survival. In addition, in the recruitment stage and after a period of 3 and 6 months, depression and anxiety questionnaire (HADS), quality of Life Questionnaire-SF36and FIM questionnaire - designed to examine the level of independence of patients with disability were performed at days 0, 90 and 180. Statistical analysis used T- Test and ANOVA Repeated Measures. The study was approved by local IRB.

Official Title
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Nutritional Support in Patients Who Have Been Diagnosed at Nutritional Risk in the Hospital and Discharged Home. How we Can Improved the Prognosis and Quality of Life.

Conditions
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Malnutrition, Quality of Life

Intervention / Treatment
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* Dietary Supplement: Food dish
* Diagnostic Test: Indirect calorimetric
* Diagnostic Test: Bioimpedance
* Behavioral: Questioners
* Dietary Supplement: Plated food dish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MUST =>2 Region of living Bney-Brak or Petah-tikwa Fine cognitive state Exclusion Criteria: Progressive cancer Dementia Fiddling by PEG or Enteral nutrient via Naso gastric tube Psychiatrics disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Measurements and questioners | Diagnostic Test: Indirect calorimetric<br>* • The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.<br>Diagnostic Test: Bioimpedance<br>* • The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .<br>Behavioral: Questioners<br>* At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given: HADS, Quality of life 36SF and FIM<br>|
| Active Comparator: Group A<br>Receiving Food dish every night for 6 months Measurements and questioners | Dietary Supplement: Food dish<br>* All patients will be assessed for nutritional risk estimates (MUST) as well as a nutritional PANDORA estimate that predicts mortality, the Pandora estimate will be measured even after 3 and 6 months Group A - will receive a dish of food every evening by a person employed by a rescue organization for 6 months At the end of the meal once a week All dishes will be photographed at the end of the meal by Android camera, iPhone A NUTRITION DAY success photo form will be completed and collected .<br>Diagnostic Test: Indirect calorimetric<br>* • The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.<br>Diagnostic Test: Bioimpedance<br>* • The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .<br>Behavioral: Questioners<br>* At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given: HADS, Quality of life 36SF and FIM<br>|
| Active Comparator: Group B<br>Receiving Food dish every night for 6 months, at this group extra attention have given to the dish plating and appearance by professional (BOCUSE), Measurements and questioners | Diagnostic Test: Indirect calorimetric<br>* • The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.<br>Diagnostic Test: Bioimpedance<br>* • The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .<br>Behavioral: Questioners<br>* At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given: HADS, Quality of life 36SF and FIM<br>Dietary Supplement: Plated food dish<br>* All patients will be assessed for nutritional risk estimates (MUST) as well as a nutritional PANDORA estimate that predicts mortality, the Pandora estimate will be measured even after 3 and 6 months Group b - will receive a food dish every evening by a person employed by a rescue organization with improved appearance of a plate for 6 months. At the end of the meal once a week All dishes will be photographed at the end of the meal by Android camera, iPhone A NUTRITION DAY success photo form will be completed and collected .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve quality of life | HADS questionnaire (hospital anxiety ans depression scale), scale 0-21. 0-7: normal; 8-10: borderline; 11-21: abnormal. | 6 months | 
| Improve quality of life | FIM questionnaire (functional indepence measure) scale 0 to 7, 1= total asistance, 7=complete independence, the highst score the best. | 6 months | 
| Improve quality of life | sf-36 questionnaire (short form health survey), scale 0-100, the highest the score the less disability | 6 months | 
| changed Mortality | six mounth follow up through ATD (American Trans Data Corp) | 6 months | 
| changed financials costs per patient in health system | follow up through electronic medical records | 6 months |