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

NCT05299541 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-03-29

No results posted yet for this study

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.

Conditions

  • Malnutrition
  • Quality of Life

Interventions

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 .

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 .

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Pierre Singer, Prof · Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-02
Primary Completion
2020-08-06
Completion
2021-01-11

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299541 on ClinicalTrials.gov