Study Stopped
Difficulties recruiting new subjects
Nutritional Support in Patients With Nutritional Risk. How we Can Improved the Prognosis and Quality of Life
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2021
CompletedFirst Submitted
Initial submission to the registry
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 29, 2022
CompletedMarch 29, 2022
March 1, 2022
3.3 years
February 14, 2022
March 28, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (3)
Control
ACTIVE COMPARATORMeasurements and questioners
Group A
ACTIVE COMPARATORReceiving Food dish every night for 6 months Measurements and questioners
Group B
ACTIVE COMPARATORReceiving 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
Interventions
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 .
• The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.
• The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .
At 3 times point , in the recruit + 3 month and 6 month 3 questioners will be given: HADS, Quality of life 36SF and FIM
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
You may qualify if:
- MUST =\>2
- Region of living Bney-Brak or Petah-tikwa
- Fine cognitive state
You may not qualify if:
- Progressive cancer
- Dementia
- Fiddling by PEG or Enteral nutrient via Naso gastric tube
- Psychiatrics disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rabin medical center
Petah Tikva, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Singer, Prof
Rabin Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ICU Manager
Study Record Dates
First Submitted
February 14, 2022
First Posted
March 29, 2022
Study Start
April 2, 2017
Primary Completion
August 6, 2020
Study Completion
January 11, 2021
Last Updated
March 29, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share