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

Primary Purpose

Malnutrition, Quality of Life

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Food dish
Indirect calorimetric
Bioimpedance
Questioners
Plated food dish
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rabin medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control

Group A

Group B

Arm Description

Measurements and questioners

Receiving Food dish every night for 6 months Measurements and questioners

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 14, 2022
Last Updated
March 28, 2022
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05299541
Brief Title
Nutritional Support in Patients With Nutritional Risk. How we Can Improved the Prognosis and Quality of Life
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulties recruiting new subjects
Study Start Date
April 2, 2017 (Actual)
Primary Completion Date
August 6, 2020 (Actual)
Study Completion Date
January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Quality of Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Measurements and questioners
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Receiving Food dish every night for 6 months Measurements and questioners
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Food dish
Intervention Description
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 .
Intervention Type
Diagnostic Test
Intervention Name(s)
Indirect calorimetric
Intervention Description
• The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.
Intervention Type
Diagnostic Test
Intervention Name(s)
Bioimpedance
Intervention Description
• The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .
Intervention Type
Behavioral
Intervention Name(s)
Questioners
Intervention Description
At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given: HADS, Quality of life 36SF and FIM
Intervention Type
Dietary Supplement
Intervention Name(s)
Plated food dish
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Improve quality of life
Description
HADS questionnaire (hospital anxiety ans depression scale), scale 0-21. 0-7: normal; 8-10: borderline; 11-21: abnormal.
Time Frame
6 months
Title
Improve quality of life
Description
FIM questionnaire (functional indepence measure) scale 0 to 7, 1= total asistance, 7=complete independence, the highst score the best.
Time Frame
6 months
Title
Improve quality of life
Description
sf-36 questionnaire (short form health survey), scale 0-100, the highest the score the less disability
Time Frame
6 months
Title
changed Mortality
Description
six mounth follow up through ATD (American Trans Data Corp)
Time Frame
6 months
Title
changed financials costs per patient in health system
Description
follow up through electronic medical records
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Singer, Prof
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin medical center
City
Petah Tikva
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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