Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission

Malnutrition Clinical Trial

— Nutriker  

Official title:

Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04244851
• Other study ID #: 35RC19_30034_NUTRIKer
• Secondary ID: 2019-A01809-48
• Status: Recruiting
• Start date: February 4, 2020
• Est. completion date: October 4, 2020

Study information

• Verified date: January 2020
• Source: Rennes University Hospital
• Contact: cecile ferragu
• Phone: 0299282555
• Email: cecile.ferragu[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge.

This study aims to determine care pathways of malnourished patients after hospital discharge and to determine what they need to better take care of their malnutrition.

Description:

All patients hospitalized in the post-emergency unit of Rennes University Hospital during the study period will be screened for malnutrition.

Data concerning newly diagnosed malnourished patients will be recorded and those patients will be contacted 3 months after their hospital discharge.

A qualitative study will be conducted among malnourished patients and their families : a sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 4, 2020
• Est. primary completion date: October 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Malnourished patients, hospitalized in the post-emergency unit during the study period, according to the malnutrition diagnostic criteria defined by the French Health Authority :

• age = 70 years old: weight loss = 5% within 1 month or = 10% within 6 months and/or BMI <21 and or serum albumin level < 35 g/l

• age < 70 years old : weight loss = 5% in 1 month or = 10% in 6 months or = 10% compared to the usual weight before the onset of the disease; or BMI <18.5 kg / m2

Non-inclusion criteria :

• refusing to participate in the study

• age < 18 years old

• patients under tutorship or guardianship

• patients living in retirement home

• Patients without a fixed address

Exclusion criteria :

-patients transferred in another unit

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Malnourished patients
Data of included patients will be recorded during hospitalization using medical charts. Every patient will be contacted by phone 3 months after hospital discharge. A sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evolution of malnutrition after hospital discharge	Malnutrition diagnostic criteria defined by the French Health Authority : If age = 70 years old : weight loss = 5% within 1 month and/or = 10% within 6 months and/or BMI < 21 kg/m² and/or serum albumin level < 35 g/l; If age < 70 years old: weight loss = 5% within 1 month and/or = 10% within 6 months and/or BMI < 18,5 kg/m² level	3 months after discharge
Secondary	Describe the path of care following the hospitalization of patients diagnosed with malnutrition at the hospital	Number of hospital readmissions; Number of family physician consultations	3 months after discharge
Secondary	Evaluate appropriation of patient regarding malnutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Secondary	Evaluate the perception of patient regarding malnutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Secondary	Evaluate expectations of patient regarding malnutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Secondary	Evaluate the needs of health professionals regarding undernutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Secondary	Evaluate the expectations of health professionals regarding undernutrition	Qualitative study by semi-structured patient interviews	3 months after discharge
Secondary	Evaluate knowledge of health professionals regarding undernutrition	Qualitative study by semi-structured patient interviews	3 months after discharge