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

Quality of Life Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05299541
• Other study ID #: 0390-16-RMC
• Status: Terminated
• Phase: N/A
• Start date: April 2, 2017
• Est. completion date: January 11, 2021

Study information

• Verified date: March 2022
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: January 11, 2021
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Quality of Life

Intervention

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.
• 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 .

Locations

Country	Name	City	State
Israel	Rabin medical center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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