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

Not Applicable

Terminated

• Conditions: Quality of Life; Malnutrition
• Interventions: Diagnostic Test: Indirect calorimetric; Dietary Supplement: Food dish; Diagnostic Test: Bioimpedance; Behavioral: Questioners; Dietary Supplement: Plated food dish

• Registration Number: NCT05299541
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-02
• Primary Completion: 2020-08-06
• Study Completion: 2021-01-11
• Study First Submitted: 2022-02-14
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Study First Posted: 2022-03-29
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Bioimpedance	Receiving Food dish every night for 6 months Measurements and questioners
Control	Questioners	Measurements and questioners
Group B	Plated food dish	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
Control	Indirect calorimetric	Measurements and questioners
Control	Bioimpedance	Measurements and questioners
Group A	Food dish	Receiving Food dish every night for 6 months Measurements and questioners
Group A	Questioners	Receiving Food dish every night for 6 months Measurements and questioners
Group B	Indirect calorimetric	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
Group A	Indirect calorimetric	Receiving Food dish every night for 6 months Measurements and questioners
Group B	Bioimpedance	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
Group B	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

Primary Outcome Measures

Name	Time	Method
Improve quality of life	6 months	sf-36 questionnaire (short form health survey), scale 0-100, the highest the score the less disability
changed Mortality	6 months	six mounth follow up through ATD (American Trans Data Corp)
changed financials costs per patient in health system	6 months	follow up through electronic medical records

Trial Locations

Locations (1)

Rabin medical center; 🇮🇱 Petah Tikva, Israel