Nutritional Support in Patients With Nutritional Risk. How we Can Improved the Prognosis and Quality of Life
NCT ID: NCT05299541
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
60 participants
INTERVENTIONAL
2017-04-02
2021-01-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
Measurements and questioners
Indirect calorimetric
• The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.
Bioimpedance
• The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .
Questioners
At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given:
HADS, Quality of life 36SF and FIM
Group A
Receiving Food dish every night for 6 months Measurements and questioners
Food dish
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 .
Indirect calorimetric
• The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.
Bioimpedance
• The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .
Questioners
At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given:
HADS, Quality of life 36SF and FIM
Group B
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
Indirect calorimetric
• The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.
Bioimpedance
• The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .
Questioners
At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given:
HADS, Quality of life 36SF and FIM
Plated food dish
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 .
Interventions
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Food dish
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 .
Indirect calorimetric
• The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.
Bioimpedance
• The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .
Questioners
At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given:
HADS, Quality of life 36SF and FIM
Plated food dish
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 .
Eligibility Criteria
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Inclusion Criteria
* Region of living Bney-Brak or Petah-tikwa
* Fine cognitive state
Exclusion Criteria
* Dementia
* Fiddling by PEG or Enteral nutrient via Naso gastric tube
* Psychiatrics disorder
18 Years
90 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Pierre Singer
ICU Manager
Principal Investigators
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Pierre Singer, Prof
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Rabin medical center
Petah Tikva, , Israel
Countries
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Other Identifiers
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0390-16-RMC
Identifier Type: -
Identifier Source: org_study_id
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