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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Malnutrition
• Intervention / Treatment: Diagnostic test: Indirect calorimetric; Diagnostic test: Bioimpedance; Behavioral: Questioners; Dietary supplement: Food dish; Dietary supplement: Plated food dish

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Measurements and questioners	Diagnostic test: Indirect calorimetric; • The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.; Diagnostic test: Bioimpedance; • The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .; Behavioral: 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
Active Comparator: Group A; Receiving Food dish every night for 6 months Measurements and questioners	Diagnostic test: Indirect calorimetric; • The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.; Diagnostic test: Bioimpedance; • The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .; Behavioral: 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; Dietary supplement: 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 .
Active Comparator: 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	Diagnostic test: Indirect calorimetric; • The patient will be measured with an indirect calorimetry device (Fitmate - COSMED Srl. Rome, Italy) to assess the nutritional requirement.; Diagnostic test: Bioimpedance; • The body composition test will be performed by the Bodystat®4000 Bioimpedance Device (BIA 4000, Bodystat, UK). .; Behavioral: 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; Dietary supplement: 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 .

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Pierre Singer, Prof, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2017
• Primary Completion (Actual): August 6, 2020
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 0390-16-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No